COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression
NCT06895863, Not applicable, Recruiting, Danish Research Centre for Magnetic Resonance
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression | ClinicalTrials.gov |
| NCT number | NCT06895863 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 78 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Danish Research Centre for Magnetic Resonance | ClinicalTrials.gov |
| Conditions | Treatment Resistant Depression | ClinicalTrials.gov |
| Interventions | MagVenture XP Orange Stimulator and active side of MagVenture COOL-B65 coil., Device: MagVenture XP Orange Stimulator and active side of MagVenture COOL-B65 coil., Sham stimulation of the MagVenture MagPro XP Orange Edition Prototype flipping the active side of the MagVenture Cool-B65 coil | ClinicalTrials.gov |
| First posted | 2025-03-26 | ClinicalTrials.gov |
| Last updated | 2026-08-26 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the Hamilton Rating Scale for Depression-6 (HDS-6) Score | 1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days). 4) Follow-up (T2): 4 weeks after end of intervention. | The HDS-6 total score reflects the severity of depression, ranging from 0 to 24, with higher scores indicating more severe symptoms. 0-6 = normal, 7-8= mild depression, 9-11 = moderate depression, 12-22 = severe to very severe depression. A 3-point change is considered to be clinically significant, which is a very conservative criterion. | ClinicalTrials.gov |
| Secondary | Change in the Hamilton Rating Scale for Depression-17 (HDS-17) Score | 1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days) . 4) Follow-up (T2): 4 weeks after end of intervention. | The HDS-17 score ranges from 0 to 52, with higher scores reflecting greater depression severity. 0-7: Normal 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression ≥23: Very severe depression | ClinicalTrials.gov |
| Secondary | Change in the WHO-5 Well-being Index (WHO-5) score | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | The World Health Organization Five Well-being Index (WHO-5) score measures overall well-being on a scale of 0 to 100, with higher scores indicating better well-being. Score Interpretation: 0-28: Poor well-being, possible clinical depression 29-50: Low mood or well-being 51-100: Good well-being | ClinicalTrials.gov |
| Secondary | Change Snaith-Hamilton Pleasure Scale (SHAPS) score | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | SHAPS measure anhedonia. The score ranges from 0 to 14, with higher scores reflecting greater levels of anhedonia | ClinicalTrials.gov |
| Secondary | Change in Overall Anxiety Severity and Impairment Scale (OASIS) score | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | OASIS The score is between 0 and 20. Higher scores indicates greater levels of anxiety and impairment. | ClinicalTrials.gov |
| Secondary | Visual analogue mood scale (VAMS) | 1) Baseline T0: (1 (+1) week before intervention. 2) On every day of intervention. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention. | Scale rating mood 1-10. Higher score indicate better mood. | ClinicalTrials.gov |
| Secondary | Change in functionality Assessment Short Test (FAST) score | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | FAST FAST assesses functional impairment. The total score range is 0 to 72. Higher scores indicate greater functional impairment. | ClinicalTrials.gov |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) score | Baseline T0: (1 (+1) week before intervention., Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2): 4 weeks after end of intervention. | PSQI assesses sleep quality. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. | ClinicalTrials.gov |
| Secondary | TMS Sensation Questionnaire (TMSens_Q) | Intervention week: before and after the first and last sessions on both days 1 and 5 | TMSens\_Q assesses and quantifies the sensation and discomfort related to transcranial magnetic stimulation. | ClinicalTrials.gov |
| Secondary | Screening for Cognitive Impairment in Psychiatry (SCIP) | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | The SCIP score ranges from 0 to 75, with lower scores indicating greater cognitive deficits. | ClinicalTrials.gov |
| Secondary | Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) score | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | COBRA uses a 4-point scale (no difficulty- severe difficulty). The score ia 0 to 36, with higher scores indicating greater cognitive difficulties. | ClinicalTrials.gov |
| Secondary | Aarhus Side effect Assessment Questionnaire (ASAQ) | Baseline T0: (1 (+1) week before intervention. Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2) 4 weeks after end of intervention. | ASAQ uses a 5-point scale (not at all to very much). The score is from 0 to 27. higher scores indicate greater presence of side effects. | ClinicalTrials.gov |
| Secondary | Young Mania Rating scale (YMRS) | Intervention week: before the first session on Day 1 and at the end of each intervention day. | The Young Mania Rating Scale (YMRS) is used to assess the potential risk of transcranial magnetic stimulation (TMS) inducing mania. It ranges from 0 to 60, with higher scores indicating more severe symptoms. 0-12: No significant mania 13-19: Mild mania 20-25: Moderate mania ≥26: Severe mania | ClinicalTrials.gov |
| Secondary | The Stroop Color and Word Test (SCWT) | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention. | SCWT uses a 4 point scale (no difficulty to severe difficulty). Fewer errors and faster completion indicate better cognitive control and executive functioning. | ClinicalTrials.gov |
| Secondary | Trail Making Test A & B (TMT) | 1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention. | TMT-A tests the times to connect all number in correct order. TMT-B tests the total time to alternate between numbers and letters. Fewer errors and faster completion indicate better cognitive control and executive functioning. | ClinicalTrials.gov |
| Secondary | Nine-hole pegboard test | 1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention. | Nine-hole pegboard test. Fewer errors and faster completion indicate better motor skills. | ClinicalTrials.gov |
| Secondary | Treatment Expectation Questionnaire (TEX-Q) | Baseline T0: (1 (+1) week before intervention. | Question about the patient's expectations for the treatment effect. | ClinicalTrials.gov |
| Other | Changes in magnetic resonance imaging (MRI) from baseline to postintervention | 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. | Structural MRI (sMRI) gives high-resolution images of the brain anatomy and allows for accurate calculation of different volumes of the brain regions. Diffusion MRI (dMRI) measures the regional diffusion properties of water and provides micro-structural information on the direction of fiber tracts and structural connectivity in relation to our stimulation targets. Functional MRI (fMRI) can map the functional connectivity of the brain during resting periods and during performing reward related tasks. | ClinicalTrials.gov |
| Other | Changes in Resting-State EEG Power Bands | Intervention week: Before and after first and last sessions on both days 1 and 5 | EEG will be used to assess changes in cortical activity power induced by a single iTBS session, as well as the cumulative effects across an intervention day. The analysis will cover the entire frequency spectrum, with a particular focus on the theta and alpha bands. Additionally, alterations in both periodic and aperiodic components of the power spectrum will be studied. | ClinicalTrials.gov |
| Other | Immediate changes in EEG power spectrum | Intervention week: During the first and last sessions on both days 1 and 5 | EEG will be used to assess acute changes in cortical power spectrum between consecutive burst trains with a particular focus on the theta and alpha band. Additionally, alterations in both periodic and aperiodic components of the power spectrum will be studied. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
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 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
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 |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | 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)