Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
NCT02367521, Phase 2, Phase 3, Completed, Johns Hopkins University; results first posted 2018-08-31
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI) | ClinicalTrials.gov |
| NCT number | NCT02367521 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 70 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | TBI Depression | ClinicalTrials.gov |
| Interventions | Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS), Sham Comparator: Sham Treatment | ClinicalTrials.gov |
| First posted | 2015-02-20 | ClinicalTrials.gov |
| Last updated | 2018-08-31 | ClinicalTrials.gov |
| Results first posted | 2018-08-31 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, \>/= 23 = Very Severe Depression. | ClinicalTrials.gov |
| Primary | Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Mean at baseline, 4, 8, 12, and 16 weeks | The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. | ClinicalTrials.gov |
| Primary | Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI) | Mean at baseline, 4, 8, 12, and 16 weeks | The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation | ClinicalTrials.gov |
| Secondary | Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT) | Mean at baseline and 16 weeks | The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the "congruous condition" in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, "incongruous condition" the color-words are printed in a different color in (ie: the word "red" is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome. | ClinicalTrials.gov |
| Secondary | Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST) | Mean at baseline and 16 weeks | The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome. | ClinicalTrials.gov |
| Secondary | Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST) | Mean at baseline and 16 weeks | The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome. | ClinicalTrials.gov |
| Secondary | Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST) | Mean at baseline and 16 weeks | The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome. | ClinicalTrials.gov |
| Secondary | Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score | Mean at baseline and 16 weeks | The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome. | ClinicalTrials.gov |
| Secondary | Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT) | Mean at baseline and 16 weeks | The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36. | ClinicalTrials.gov |
| Secondary | Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT) | Mean at baseline and 16 weeks | The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say "yes" after each word that appeared on the recall list (12 targets) and "no" after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60) | ClinicalTrials.gov |
| Secondary | Delayed Recall as Assessed by Brief Visual Memory Test (BVMT) | Mean at baseline and 16 weeks | BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Immediate Recall as Assessed by Brief Visual Memory Test (BVMT) | Mean at baseline and 16 weeks | BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome. | ClinicalTrials.gov |
| Secondary | Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score | Mean at baseline and 16 weeks | Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome. | ClinicalTrials.gov |
| Secondary | Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire | Baseline, 4, 8, 12, and 16 weeks | The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21. 0-4 = normal 5-9 = mild 10-14 = moderate \>15 = severe | ClinicalTrials.gov |
| Secondary | Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS) | Baseline, 4, 8, 12, and 16 weeks | The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD). Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome. | ClinicalTrials.gov |
| Secondary | Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI) | Baseline, 4, 8, 12, and 16 weeks | The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of "5" or greater is indicative of poor sleep quality (reflecting a higher level of fatigue) | ClinicalTrials.gov |
| Secondary | Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS) | Baseline, 4, 8, 12, and 16 weeks | The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness. | ClinicalTrials.gov |
| Secondary | Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA) | Mean at baseline and 16 weeks | MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following: Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education. Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment. | ClinicalTrials.gov |
| Secondary | Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS) | Mean at baseline, 4, 8, 12, and 16 weeks | The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms. | ClinicalTrials.gov |
| Secondary | Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ) | Mean at baseline, 4, 8, 12, and 16 weeks | Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms. | ClinicalTrials.gov |
Outcomes 24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Mean at baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI) | Mean at baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT) | Mean at baseline and 16 weeks | items completed | MEAN | ClinicalTrials.gov | |
| SECONDARY | Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST) | Mean at baseline and 16 weeks | completed categories | MEAN | ClinicalTrials.gov | |
| SECONDARY | Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST) | Mean at baseline and 16 weeks | errors | MEAN | ClinicalTrials.gov | |
| SECONDARY | Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST) | Mean at baseline and 16 weeks | correct trials | MEAN | ClinicalTrials.gov | |
| SECONDARY | Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score | Mean at baseline and 16 weeks | seconds | MEAN | ClinicalTrials.gov | |
| SECONDARY | Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT) | Mean at baseline and 16 weeks | sum of correctly-recalled words | MEAN | ClinicalTrials.gov | |
| SECONDARY | Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT) | Mean at baseline and 16 weeks | T-score of correctly-recalled words | MEAN | ClinicalTrials.gov | |
| SECONDARY | Delayed Recall as Assessed by Brief Visual Memory Test (BVMT) | Mean at baseline and 16 weeks | accurately-drawn figures | MEAN | ClinicalTrials.gov | |
| SECONDARY | Immediate Recall as Assessed by Brief Visual Memory Test (BVMT) | Mean at baseline and 16 weeks | accurately-drawn figures | MEAN | ClinicalTrials.gov | |
| SECONDARY | Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score | Mean at baseline and 16 weeks | seconds | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire | Baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS) | Baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI) | Baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS) | Baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA) | Mean at baseline and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS) | Mean at baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ) | Mean at baseline, 4, 8, 12, and 16 weeks | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | LFR rTMS | Baseline | 23.154 | Standard Deviation 4.375 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Sham Treatment | Baseline | 23.076 | Standard Deviation 4.356 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | LFR rTMS | 4 weeks | 13.154 | Standard Deviation 8.444 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Sham Treatment | 4 weeks | 12.706 | Standard Deviation 6.697 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | LFR rTMS | 8 weeks | 12.538 | Standard Deviation 9.744 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Sham Treatment | 8 weeks | 12.647 | Standard Deviation 6.901 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | LFR rTMS | 12 weeks | 14.077 | Standard Deviation 10.21 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Sham Treatment | 12 weeks | 12.824 | Standard Deviation 8.435 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | LFR rTMS | 16 weeks | 11.154 | Standard Deviation 9.529 | units on a scale | ClinicalTrials.gov |
| Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale | Sham Treatment | 16 weeks | 12.941 | Standard Deviation 8.877 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | LFR rTMS | CGI Baseline (severity) | 4.846 | Standard Deviation 0.801 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Sham Treatment | CGI Baseline (severity) | 5 | Standard Deviation 0.791 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | LFR rTMS | CGI 4 weeks (improvement) | 2.308 | Standard Deviation 1.109 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Sham Treatment | CGI 4 weeks (improvement) | 2.824 | Standard Deviation 1.334 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | LFR rTMS | CGI 8 weeks (improvement) | 2.385 | Standard Deviation 1.044 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Sham Treatment | CGI 8 weeks (improvement) | 2.471 | Standard Deviation 1.125 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | LFR rTMS | CGI 12 weeks (improvement) | 2.385 | Standard Deviation 1.0444 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Sham Treatment | CGI 12 weeks (improvement) | 2.588 | Standard Deviation 1.064 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | LFR rTMS | CGI 16 weeks (improvement) | 2.077 | Standard Deviation 0.854 | units on a scale | ClinicalTrials.gov |
| Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) | Sham Treatment | CGI 16 weeks (improvement) | 2.471 | Standard Deviation 1.281 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | LFR rTMS | 17 | ClinicalTrials.gov | |
| Overall Study | STARTED | Sham Treatment | 17 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | LFR rTMS | 13 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Sham Treatment | 17 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | LFR rTMS | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Sham Treatment | 0 | ClinicalTrials.gov |
Adverse events 24
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 | Headache | Nervous system disorders | LFR rTMS | 5 | 17 | 12 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Sham Treatment | 5 | 17 | 12 | ClinicalTrials.gov |
| other | Depression | Psychiatric disorders | LFR rTMS | 1 | 17 | 4 | ClinicalTrials.gov |
| other | Depression | Psychiatric disorders | Sham Treatment | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Anxiety | Psychiatric disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Anxiety | Psychiatric disorders | Sham Treatment | 1 | 17 | 3 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Sham Treatment | 1 | 17 | 2 | ClinicalTrials.gov |
| other | Blurred Vision | Nervous system disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Blurred Vision | Nervous system disorders | Sham Treatment | 0 | 17 | 0 | ClinicalTrials.gov |
| other | Tiredness | Nervous system disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Tiredness | Nervous system disorders | Sham Treatment | 0 | 17 | 0 | ClinicalTrials.gov |
| other | Discomfort | Nervous system disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Discomfort | Nervous system disorders | Sham Treatment | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Puff Face | Skin and subcutaneous tissue disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Puff Face | Skin and subcutaneous tissue disorders | Sham Treatment | 0 | 17 | 0 | ClinicalTrials.gov |
| other | Face Twitching | Nervous system disorders | LFR rTMS | 0 | 17 | 0 | ClinicalTrials.gov |
| other | Face Twitching | Nervous system disorders | Sham Treatment | 1 | 17 | 2 | ClinicalTrials.gov |
| other | Eye Twitching | Nervous system disorders | LFR rTMS | 1 | 17 | 1 | ClinicalTrials.gov |
| other | Eye Twitching | Nervous system disorders | Sham Treatment | 0 | 17 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | LFR rTMS | 0 | 17 | ClinicalTrials.gov |
| Total, all-cause mortality | Sham Treatment | 0 | 17 | ClinicalTrials.gov |
| Total, other adverse events | LFR rTMS | 6 | 17 | ClinicalTrials.gov |
| Total, other adverse events | Sham Treatment | 7 | 17 | ClinicalTrials.gov |
| Total, serious adverse events | LFR rTMS | 0 | 17 | ClinicalTrials.gov |
| Total, serious adverse events | Sham Treatment | 0 | 17 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LFR rTMS vs Sham Treatment: deaths from any cause | Trial comparisons |
| LFR rTMS vs Sham Treatment: serious adverse events | Trial comparisons |
Tests 4
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 |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | 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)