Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
NCT02969707, Not applicable, Completed, Stanford University; results first posted 2021-08-30
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia | ClinicalTrials.gov |
| NCT number | NCT02969707 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 101 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Stanford University | ClinicalTrials.gov |
| Conditions | Fibromyalgia | ClinicalTrials.gov |
| Interventions | MagPro TMS system (MagVenture, Denmark), Hypnosis | ClinicalTrials.gov |
| First posted | 2016-11-21 | ClinicalTrials.gov |
| Last updated | 2024-12-20 | ClinicalTrials.gov |
| Results first posted | 2021-08-30 | ClinicalTrials.gov |
| Limitations and caveats | fMRI BOLD data were preprocessed using fMRIPrep 1.5.10 (Esteban, Markiewicz, et al. (2018); Esteban, Blair, et al. (2018); RRID:SCR\_016216), which is based on Nipype 1.4.2 (Gorgolewski et al. (2011); Gorgolewski et al. (2018); RRID:SCR\_002502) with MNI152NLin2009cAsym and anatomical output spaces. BOLD time series were bandpass filtered to include data in the window of 0.0025-0.025 Hz, which is on the low end of the spectrum. A more typical bandpass window is 0.01 - 0.1 Hz. | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Baseline and at 15-20 min post-TMS (up to 30 min) | Functional MRI (fMRI) measures changes in oxygenated blood in the brain; at rest these levels fluctuate over time. These fluctuations can be similar between different brain regions. FC is the similarity in fluctuations of these fMRI signals and suggests how strongly two regions communicate with each other. We measured how inhibitory continuous theta-burst stimulation (cTBS) over L-DLPFC changes FC between L-DLPFC and dACC. This was done by estimating z-transformed correlation coefficients (CC) for each voxel (-1 to 1) between the L-DLPFC and dACC pre and post cTBS intervention. Negative FC was assigned to voxels with a weight \< 0, positive FC to voxels with weight\> 0. Total FC includes positive and negative voxels. The change in FC is regarded as the change in the sum of these weighted voxels from pre to post cTBS for total, positive and negative FC, respectively. Greater sums of voxels correspond to more significant levels of coordinated activity (positive, negative, or total). | ClinicalTrials.gov |
| Secondary | The Change in the Neural Network Underlying Hypnotic Intensity | Baseline and 2 hours | Blood oxygen level dependent (BOLD) signal and interleaved TMS-BOLD analyses will be used to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on modulating the neural network that underlies hypnotic intensity. | ClinicalTrials.gov |
| Secondary | Change in Hypnotic Induction Profile Score | Baseline and Immediately post rTMS (up to 30 min) | The investigators used the Hypnotic Induction Profile (HIP) to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on enhancing hypnotizability. HIP scores range from 0 to 10 (low to high hypnotizability). | ClinicalTrials.gov |
| Secondary | Change in The Hypnosis Intensity Scale | Baseline and immediately post rTMS (up to 2 hrs) | The investigators used the Hypnotic Intensity Scale (HIS) to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on enhancing hypnotic intensity. HIS scores range from 0 to 10 (low to high hypnotic intensity). | ClinicalTrials.gov |
| Secondary | The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Baseline and at 15-20 min post-TMS (up to 30 min) | We examined the effect of active, inhibitory cTBS over L-DLPFC on functional connectivity (FC) in key nodes in the neural network underlying the conflict regulation system. FC between each voxel in the L-DLPFC and the entire dACC was established by estimating z-transformed correlation coefficients (CC) for each voxel (-1 to 1) pre and post cTBS intervention. This paradigm was also used for voxels in the Default Mode Network (DMN) (Schaefer, 2018; Yeo, 2011) to the entire right inferior frontal gyrus (rIFG). Negative FC was assigned to voxels with a weight \< 0, positive FC to voxels with weight \> 0. Total FC includes positive and negative voxels. The change in FC is regarded as the change in the sum of these weighted voxels from pre to post cTBS for total, positive and negative FC, respectively. Greater sums of voxels correspond to more significant levels of coordinated activity (positive, negative, or total). | ClinicalTrials.gov |
| Secondary | The Change in Stroop Performance | Baseline and at 15-20 min post-TMS (up to 30 min) | Stroop effect is measured by the response time of a participant during the stroop task. Increases in response time indicate increased stroop effect (SE) and vice versa. | ClinicalTrials.gov |
| Secondary | Stroop Task | Baseline and at 15-20 min post-TMS (up to 30 min) | Active, inhibitory cTBS effect over L-DLPFC on the neural network that underlies the hypnotic Stroop modulation effect was determined by first estimating the average of connectivity weights for all parcel pairs linking Ventral Attentional Network (VAN) to the DMN. Parcels are determined by extracting mean resting state BOLD time-series for each region of the Schaefer 100 parcellation. A correlation matrix between all parcels is created and FC weights for each pair are established by estimating z-transformed correlation coefficients (CC) (-1 to 1). Each parcel pair is then assigned to one of the 7 resting state networks defined by Yeo et al., (2011). Negative FC is defined for parcel pairs with a weight \< 0, positive FC pairs with weight \> 0 and total FC includes all pairs. FC is thus the average value between parcel pairs in the DMN and VAN pre/post TMS. Greater sums of weighted pairs correspond to more significant levels of coordinated activity (positive, negative, or total). | ClinicalTrials.gov |
| Secondary | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With no Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Spearman's correlation was used to determine the linear relationship between the response time taken to answer incongruent Stroop task blocks (a measure of Stroop performance) and the change the resting-state network FC between the VAN and the DMN when no hypnosis intervention was implemented. | ClinicalTrials.gov |
| Secondary | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Spearman's correlation was used to determine the linear relationship between the response time taken to answer incongruent Stroop task blocks (a measure of Stroop performance) and the change the resting-state network FC between the VAN and the DMN when the hypnosis intervention was implemented. | ClinicalTrials.gov |
| Secondary | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With no Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Spearman's correlation was used to determine the linear relationship between the Stroop interference and the change the resting-state network FC between the VAN and the DMN when no hypnosis intervention was implemented. In psychology, the Stroop effect is the delay in reaction time between congruent and incongruent stimuli. | ClinicalTrials.gov |
| Secondary | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Spearman's correlation was used to determine the linear relationship between the Stroop interference and the change the resting-state network FC between the VAN and the DMN when the hypnosis intervention was implemented. In psychology, the Stroop effect is the delay in reaction time between congruent and incongruent stimuli. | ClinicalTrials.gov |
| Secondary | Change in the Numeric Pain Rating Scale | Baseline and immediately post-rTMS (up to 30 minutes) | To determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on modulating the neural network that underlies hypnotic analgesia (HA). Numeric Pain Rating Scale scores range from 0 to 10 (low to high pain intensity). | ClinicalTrials.gov |
| Secondary | Change in Sense of Agency Rating Scale (SOARS) | Baseline and immediately post-rTMS (up to 30 min) | The investigators used the Sense of Agency Rating Scale (SOARS) to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on altering the subjective sense of agency during hypnotizability. SOARS scores are calculated for Involuntariness and Effortlessness, each range from 0 to 35 (low to high). | ClinicalTrials.gov |
| Secondary | Metabolic Alterations in Fibromyalgia (FMS) Defined by Excitatory / Inhibitory Ratio | Baseline Scan (up to 15 min) | E/I ratio is defined as the logarithm of the concentration of Glx (excitatory neurotransmitter metabolite complex) /GABA+ (inhibitory neurotransmitter metabolite complex) relative to either water or creatine peak signal and it is a unitless measure ranging from -1 to 1. Logarithmic transformations are used to account for non-normal distributions of metabolite concentrations across participants and ratios \> 0 are thought to be excitatory neurotransmitter dominant while ratios \<0 are thought to be inhibition dominant. | ClinicalTrials.gov |
| Secondary | Alterations in Pain Perception in Fibromyalgia | Baseline visit (up to 30 min) | To characterize clinical pain measures, which are defined as thermal pain threshold and thermal pain tolerance. Thermal pain threshold is determined as the temperature of a thermode determined as painful (degrees Celsius) by a participant. Thermal pain tolerance extends this to the point at which discontinuation is necessary (degrees Celsius). | ClinicalTrials.gov |
| Secondary | Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable. | ClinicalTrials.gov |
| Secondary | Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable. | ClinicalTrials.gov |
| Secondary | Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable. | ClinicalTrials.gov |
| Secondary | Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable. | ClinicalTrials.gov |
| Secondary | Metabolic Changes in L-DLPFC Pre- and Post-rTMS | Baseline Scan and at 15-20 min post-TMS (up to 30 min) | To determine the relationship between the metabolic alterations pre and post-rTMS. Metabolic changes as measured by MEGA-PRESS spectroscopy were assessed by quantification of excitatory (Glx) and inhibitory (GABA+) neurotransmitter complexes. The E/I ratio is defined as the logarithm of the concentration of Glx/GABA+relative to either the reference water or creatine signal and it is a unitless measure ranging from -1 to 1. Logarithmic transformations are used to account for non-normal distributions of metabolite concentrations across participants and ratios \> 0 are thought to be excitatory neurotransmitter dominant while ratios \<0 are thought to be inhibition dominant. | ClinicalTrials.gov |
Outcomes 20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Baseline and at 15-20 min post-TMS (up to 30 min) | Participants with resting-state scans for both pre and post-TMS conditions that passed QC and motion-based scan inclusion criteria; outlier data were excluded. | Z-transformed CC | MEAN | ClinicalTrials.gov |
| SECONDARY | The Change in the Neural Network Underlying Hypnotic Intensity | Baseline and 2 hours | During the study, data were not collected using interleaved TMS-BOLD, as originally planned. | ClinicalTrials.gov | ||
| SECONDARY | Change in Hypnotic Induction Profile Score | Baseline and Immediately post rTMS (up to 30 min) | Participants with available data are included in the analysis | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in The Hypnosis Intensity Scale | Baseline and immediately post rTMS (up to 2 hrs) | Participants who completed the protocol and completed HIS ratings are included in the analysis. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Baseline and at 15-20 min post-TMS (up to 30 min) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) fMRI imaging problems, 2) missing data. For the analyses below additional outliers were excluded on a test by test basis. | Z-transformed CC | MEAN | ClinicalTrials.gov |
| SECONDARY | The Change in Stroop Performance | Baseline and at 15-20 min post-TMS (up to 30 min) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) poor Stroop task performance, 2) fMRI imaging problems, 3) missing data. For the analyses below additional outliers were excluded on a test by test basis. | Seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Stroop Task | Baseline and at 15-20 min post-TMS (up to 30 min) | Subjects who had pre and post TMS resting-state fMRI scans that passed QC and motion-based inclusion criteria | Z-transformed CC | MEAN | ClinicalTrials.gov |
| SECONDARY | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With no Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) poor Stroop task performance, 2) fMRI imaging problems, 3) missing data. Subjects who had pre and post TMS resting-state fMRI scans that passed QC and motion-based inclusion criteria were included. | Correlation Coefficient | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) poor Stroop task performance, 2) fMRI imaging problems, 3) missing data. Subjects who had pre and post TMS resting-state fMRI scans that passed QC and motion-based inclusion criteria were included. | Correlation Coefficient | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With no Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) poor Stroop task performance, 2) fMRI imaging problems, 3) missing data. Subjects who had pre and post TMS resting-state fMRI scans that passed QC and motion-based inclusion criteria were included. | Correlation Coefficient | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With Hypnosis Intervention. | Baseline and at 15-20 min post-TMS (up to 1 hr) | Population consisted of patients with fibromyalgia who underwent either active or sham cTBS either in combination with hypnosis or without it. Participants were excluded from the original sample for 1) poor Stroop task performance, 2) fMRI imaging problems, 3) missing data. Subjects who had pre and post TMS resting-state fMRI scans that passed QC and motion-based inclusion criteria were included. | Correlation Coefficient | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change in the Numeric Pain Rating Scale | Baseline and immediately post-rTMS (up to 30 minutes) | Participants with available data are included in the analysis | mean change of scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Sense of Agency Rating Scale (SOARS) | Baseline and immediately post-rTMS (up to 30 min) | Participants who completed the protocol and completed all items of the SOARS are included in the analysis. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Metabolic Alterations in Fibromyalgia (FMS) Defined by Excitatory / Inhibitory Ratio | Baseline Scan (up to 15 min) | Participants with baseline MegaPress scan data | Ratio | MEAN | ClinicalTrials.gov |
| SECONDARY | Alterations in Pain Perception in Fibromyalgia | Baseline visit (up to 30 min) | Participants with baseline MegaPress scan data | Degrees Celsius | MEAN | ClinicalTrials.gov |
| SECONDARY | Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Participants with baseline MegaPress scan data | Coefficient of determination | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Participants with baseline MegaPress scan data | Coefficient of determination | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Participants with baseline MegaPress scan data | Coefficient of determination | NUMBER | ClinicalTrials.gov |
| SECONDARY | Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) | Baseline visit (up to 45 min) | Participants with baseline MegaPress scan data | Coefficient of determination | NUMBER | ClinicalTrials.gov |
| SECONDARY | Metabolic Changes in L-DLPFC Pre- and Post-rTMS | Baseline Scan and at 15-20 min post-TMS (up to 30 min) | Participants with available data | Ratio | MEAN | ClinicalTrials.gov |
Results by group 64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Active rTMS | Change in sum of positive z-transformed CC. | 61.98 | Standard Error 21.63 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Sham rTMS | Change in sum of positive z-transformed CC. | 4.16 | Standard Error 16.43 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Active rTMS | Change in sum of negative z-transformed CC. | -21.41 | Standard Error 16.8 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Sham rTMS | Change in sum of negative z-transformed CC. | -13.22 | Standard Error 16.8 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Active rTMS | Change in sum of all z-transformed CC. | 40.56 | Standard Error 32.34 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) | Sham rTMS | Change in sum of all z-transformed CC. | -9.06 | Standard Error 28.25 | Z-transformed CC | ClinicalTrials.gov |
| Change in Hypnotic Induction Profile Score | Active rTMS | .63 | Standard Deviation 1.18 | score on a scale | ClinicalTrials.gov | |
| Change in Hypnotic Induction Profile Score | Sham rTMS | .31 | Standard Deviation 1.67 | score on a scale | ClinicalTrials.gov | |
| Change in The Hypnosis Intensity Scale | Active rTMS | .475 | Standard Deviation 2.242 | score on a scale | ClinicalTrials.gov | |
| Change in The Hypnosis Intensity Scale | Sham rTMS | -.128 | Standard Deviation 1.490 | score on a scale | ClinicalTrials.gov | |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Active rTMS | Change in sum of all z-transformed CC in L-DLPFC. | 0.01 | Standard Deviation 0.14 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Sham rTMS | Change in sum of all z-transformed CC in L-DLPFC. | -0.003 | Standard Deviation 0.13 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Active rTMS | Change in sum of positive z-transformed CC in L-DLPFC. | 33.76 | Standard Deviation 136.5 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Sham rTMS | Change in sum of positive z-transformed CC in L-DLPFC. | 6.39 | Standard Deviation 99.82 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Active rTMS | Change in sum of negative z-transformed CC in L-DLPFC. | -20.36 | Standard Deviation 88.88 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Sham rTMS | Change in sum of negative z-transformed CC in L-DLPFC. | -10.11 | Standard Deviation 96.55 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Active rTMS | Change in sum of all z-transformed CC in DMN. | 0.004 | Standard Deviation 0.05 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Sham rTMS | Change in sum of all z-transformed CC in DMN. | -0.01 | Standard Deviation 0.05 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Active rTMS | Change in sum of positive z-transformed CC in DMN. | -31.20 | Standard Deviation 137.73 | Z-transformed CC | ClinicalTrials.gov |
| The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. | Sham rTMS | Change in sum of positive z-transformed CC in DMN. | 21.12 | Standard Deviation 153.54 | Z-transformed CC | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Active rTMS | 49 | ClinicalTrials.gov | |
| Overall Study | STARTED | Sham rTMS | 52 | ClinicalTrials.gov | |
| Overall Study | Received Intervention | Active rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | Received Intervention | Sham rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | Completed Pain Evaluation Study Day | Active rTMS | 41 | ClinicalTrials.gov | |
| Overall Study | Completed Pain Evaluation Study Day | Sham rTMS | 44 | ClinicalTrials.gov | |
| Overall Study | Completed Mechanistic Evaluation Study Day | Active rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | Completed Mechanistic Evaluation Study Day | Sham rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Active rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Sham rTMS | 40 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Active rTMS | 9 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Sham rTMS | 12 | ClinicalTrials.gov |
Adverse events 6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Medication Withdrawal During Washout | Metabolism and nutrition disorders | Active rTMS | 0 | 49 | 0 | ClinicalTrials.gov |
| other | Medication Withdrawal During Washout | Metabolism and nutrition disorders | Sham rTMS | 1 | 52 | 1 | ClinicalTrials.gov |
| other | Headache / Scalp Irritation | Skin and subcutaneous tissue disorders | Active rTMS | 1 | 49 | 1 | ClinicalTrials.gov |
| other | Headache / Scalp Irritation | Skin and subcutaneous tissue disorders | Sham rTMS | 0 | 52 | 0 | ClinicalTrials.gov |
| other | Dizziness | Ear and labyrinth disorders | Active rTMS | 0 | 49 | 0 | ClinicalTrials.gov |
| other | Dizziness | Ear and labyrinth disorders | Sham rTMS | 1 | 52 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Active rTMS | 0 | 49 | ClinicalTrials.gov |
| Total, all-cause mortality | Sham rTMS | 0 | 52 | ClinicalTrials.gov |
| Total, other adverse events | Active rTMS | 1 | 49 | ClinicalTrials.gov |
| Total, other adverse events | Sham rTMS | 2 | 52 | ClinicalTrials.gov |
| Total, serious adverse events | Active rTMS | 0 | 49 | ClinicalTrials.gov |
| Total, serious adverse events | Sham rTMS | 0 | 52 | ClinicalTrials.gov |
Papers 16
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 9252330 | BACKGROUND | PubMed |
| 10467921 | BACKGROUND | PubMed |
| 10700332 | BACKGROUND | PubMed |
| 12470132 | BACKGROUND | PubMed |
| 15994228 | BACKGROUND | PubMed |
| 18185107 | BACKGROUND | PubMed |
| 18653363 | BACKGROUND | PubMed |
| 19937376 | BACKGROUND | PubMed |
| 21764215 | BACKGROUND | PubMed |
| 22613775 | BACKGROUND | PubMed |
| 22835528 | BACKGROUND | PubMed |
| 23026956 | BACKGROUND | PubMed |
| 24828639 | BACKGROUND | PubMed |
| 25505220 | BACKGROUND | PubMed |
| 26049149 | BACKGROUND | PubMed |
| 27469596 | BACKGROUND | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R33AT009305 | Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia | WILLIAMS, NOLAN R.; SPIEGEL, DAVID | STANFORD UNIVERSITY | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2016 to 2018 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active rTMS vs Sham rTMS: deaths from any cause | Trial comparisons |
| Active rTMS vs Sham rTMS: serious adverse events | Trial comparisons |
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)