NCT07587112

Brief Summary

The purpose of this study is to investigate the differences in therapeutic efficacy of different deep TMS treatment coils and different brain stimulation targets on obsessive-compulsive symptoms, and to explore the neural mechanisms of obsessive-compulsive disorder using functional neuroimaging analysis.

  1. 1.Inclusion Criteria:
  2. 2.Study Design: Double-blind, randomized assignment.
  3. 3.Number of Participants:
  4. 4.Study Procedures:
  5. 5.Statistical Analysis
  6. 6.Expected Outcomes: The H7 coil may improve obsessive-compulsive symptoms. Both the H7 and H1 coils may improve mood symptoms. \- Descriptive and Inferential Statistics: Analysis of covariance (ANCOVA) will be used to compare differences among the three groups in MADRS, Y-BOCS, HAM-A, HDRS, and CGI-S scores. The percentage of responders (% responders) will be calculated and compared among groups. Repeated-measures ANOVA will be used to examine within-group and between-group differences in symptom improvement before and after deep TMS treatment. Pearson correlation analysis will be used to assess the association between symptom improvement and changes observed in PET/MRI neuroimaging measures. \- PET/MRI Neuroimaging Analysis: Functional MRI analyses will include ROI-to-ROI functional connectivity and seed-based functional connectivity analyses. Changes in PET glucose uptake within specific regions of interest (ROIs) will also be examined to evaluate alterations in neural networks and brain function before and after deep TMS treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2025Dec 2027

Study Start

First participant enrolled

September 22, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Obsessive-Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

  • the percentage changes in Y-BOCS scores after treatments

    Two time-spans are assessed: (a) from baseline (Week 0, W0) to posttreatment (Week 6, W6), and (b) from baseline (W0) to the 2-week follow-up (Week 8, W8). The percentage changes in Y-BOCS scores will be calculated as follows: 1. % of YBOCS6-0 = (W6 - W0) / W0 2. % of YBOCS8-0 = (W8 - W0) / W0 A full treatment response, defined as a ≥30% reduction in Y-BOCS score from baseline, will be evaluated at both the 6-week and 8-week time points.

    the 6-week and 8-week

Study Arms (3)

Active H7 coil stimulation

EXPERIMENTAL

Active H7 coil stimulation

Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)

Sham stimulation group

SHAM COMPARATOR

Sham stimulation group

Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)

Active H1 coil group

EXPERIMENTAL

Active H1 coil group

Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)

Interventions

Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)DEVICE

Sham dTMS Participants will receive sham deep TMS using a sham coil. H7 dTMS Participants will receive active deep TMS using the H7 coil. H1 dTMS Participants will receive active deep TMS using the H1 coil.

Active H1 coil groupActive H7 coil stimulationSham stimulation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years.
  • Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. Treatment resistance (i.e., inadequate response to pharmacological or non-pharmacological treatments) is not required.
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 14, indicating at least mild to moderate symptom severity.

You may not qualify if:

  • Diagnosis of schizophrenia, organic psychotic disorder, bipolar disorder, alcohol use disorder, or substance use disorder.
  • High suicide risk within the past year.
  • Presence of significant medical or surgical conditions in an active phase.
  • History of, or planned, neurosurgical procedures, or presence of metallic implants in the brain or body (e.g., neurostimulators or cardiac pacemakers).
  • Structural brain abnormalities (e.g., brain tumor or arteriovenous malformation) or neurological disorders (e.g., meningitis, encephalitis, stroke, or epilepsy).
  • Pregnant women.
  • Inability to tolerate PET/MRI examination due to claustrophobia or severe anxiety in confined spaces.
  • Any other conditions that may impair study compliance, including inability to cooperate, failure to provide informed consent, or other investigator-determined ineligibility after screening.
  • Use of medications that may increase seizure risk or suicide risk (e.g., certain antidepressants or antipsychotics).
  • Known allergy to 18F-FDG.
  • History of adverse reaction to TMS or allergy to the positioning cap.
  • Presence of metallic objects within approximately 30 cm of the cranial region (within the stimulation coil area).
  • Prior or current treatment with electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.

    PMID: 28927961BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Central Study Contacts

Cheng-Ta Li

CONTACT

886-2-55704055ctli0420@gmail.com

Chia-Min Huang

CONTACT

psygrace1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

September 22, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations

TW(1)