Predictors of response to deep transcranial magnetic stimulation treatment in obsessive-compulsive disorder

Phase 3

• Conditions: Obsessive-compulsive disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN17144095
• Lead Sponsor: 3rd Medical Faculty, Charles University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-16
• Last Update Posted: 28 November 2023
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Male and female outpatients aged 18-70 years;
2. Meeting DSM-V criteria for OCD;
3. Patients having completed at least one unsuccessful but adequate antidepressant treatment according to criteria for treatment-resistant OCD (treatment history is sufficient);
4. Being able to understand and sign the Informed Consent Form;
5. Being on a stable and adequate dose of antidepressants and/or antipsychotics (monotherapy or combination) for at least eight weeks before the commencement of dTMS, if used.
6. Y-BOCS score =20 corresponding to the Severity scale = three on Clinical Global Impression on the initial visit.

Exclusion Criteria

1. Psychiatric comorbidity on axis I and II according to DSM V six months before enrollment to the study except for depressive, anxiety, and obsessive-compulsive related disorders;
2. Personality disorder that makes participation in the trial difficult;
3. History of substance dependence in the last year except for nicotine;
4. Contraindications of rTMS/dTMS treatment;
5. Pregnancy or breast-feeding;
6. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders, etc.);
7. Patients treated with electroconvulsive therapy less than three months before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment that can strongly affect EEG;
8. Substantial suicidal risk as judged by the treating psychiatrist;
9. Sensory and motor impairment precluding the participation in computer tests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
euronal predictors of therapeutic success of mPFC-dTMS in OCD patients using MRI by evaluating pre- and post-treatment dTMS-mPFC changes in grey matter (GM) in the anterior cingulate cortex (ACC), mPFC, OFC, and striatum, and WM in selected tracts and bundles using fMRI.

Secondary Outcome Measures

Name	Time	Method
euronal predictors of therapeutic success of mPFC-dTMS in OCD patients using EEG and MRI by evaluating pre- and post-treatment dTMS-mPFC changes in:<br>1. EEG resting state oscillations; <br>2. ERN during the Flanker task; <br>3. Resting-state FC of the ACC, striatum, and the prefrontal cortex (PFC)/OFC <br>4. Blood oxygenation level-dependent (BOLD) - functional MRI (fMRI) activations during the exposure to individual OCD symptoms-related visual stimuli.