Accelerated rTMS in Hospitalized Patients With OCD: a Feasibility and Mechanistic Study
NCT ID: NCT07135414
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-25
2030-12-31
Brief Summary
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Patients will be randomly assigned to one of three groups: two groups will receive either dTMS or iTBS combined with Exposure and Response Prevention (ERP), a recognized psychotherapy for OCD; the third group will receive only ERP without rTMS.
Participant Requirements next to treatment:
Questionnaires: Patients will complete surveys before the treatment period, immediately after the treatment period, and four weeks post-treatment.
MRI \& EEG: Patients will undergo brain imaging (MRI) and brain wave (EEG) recordings before and after the treatment period.
Adverse Effects Diary: Patients will maintain a daily log of any side effects experienced during the treatment period.
The study aims to assess the feasibility, safety, and effectiveness of this combined treatment approach and to examine its effects on underlying brain processes related to clinical outcomes.
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Detailed Description
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The study protocol consists of three arms. All arms include Exposure and Response Prevention (ERP), an established psychotherapeutic treatment for OCD. Two arms will investigate two different types of rTMS: conventional deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both rTMS treatments will be administered using an accelerated protocol, involving four sessions per day. The third arm consists of ERP without any form of neuromodulation (i.e., treatment-as-usual).
Study Design:
This is a randomized clinical trial (RCT) evaluating the feasibility, efficacy, safety, and suitability of the two types of accelerated rTMS protocols, in addition to ERP therapy in patients with OCD. The study also aims to investigate the neural mechanisms underlying these treatment approaches.
Patients will be randomly assigned by a computer program to one of three treatment groups. All groups will receive ERP. Two groups will receive either iTBS or dTMS combined with ERP, and the third group will receive ERP without rTMS.
Participant Requirements:
Questionnaires: Completion of surveys before treatment, immediately after treatment, and four weeks post-treatment.
MRI \& EEG: Undergo functional and structural brain imaging (MRI) and high-definition electroencephalography (hdEEG) before and after the treatment period.
Adverse Effects Diary: Maintain a daily log of any side effects experienced during the treatment period.
Study Duration:
The total expected duration of participation is ten weeks. Magnetic stimulation treatment will take place over two weeks, within a standard hospitalization of twelve weeks in an OCD inpatient department. Participation does not require additional hospital visits compared to usual treatment.
Study Location:
The study will be conducted at UZ Gent, Building K12F, Corneel Heymanslaan 10, 9000 Ghent, Belgium. A total of 60 patients will participate, with 40 patients receiving rTMS treatment. All procedures will take place within Belgium.
Participant Involvement:
During the twelve-week hospitalization, rTMS treatment will commence approximately two weeks after admission. The initial two-week period allows for familiarization with the department and ERP therapy. Prior to inclusion, eligibility will be assessed through a 60-minute consultation, a semi-structured diagnostic interview (MINI-5), and a structured assessment of OCD symptoms (Y-BOCS symptom checklist) to identify any exclusion criteria or contraindications.
Eligible patients will undergo two brain imaging procedures: functional and structural MRI and hdEEG. Additionally, five questionnaires will be administered collectively.
The rTMS protocol will then be implemented over a two-week period, with four sessions per day, four days per week, totaling 32 sessions. During this period, patients will complete a daily adverse effects questionnaire. Immediately after treatment, post-treatment assessments will include questionnaires and repeated fMRI and hdEEG scans. Four weeks later, follow-up questionnaires assessing OCD symptoms and related measures will be completed.
Certain visits and procedures described in the study will be part of standard care at the hospital, while others are specific to the research protocol. Throughout the twelve-week hospitalization, all groups will receive standard care, including medication optimization and evidence-based psychotherapeutic interventions for OCD. rTMS will be offered as an adjunctive treatment to this standard care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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dTMS + ERP
20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.
dTMS
Deep TMS (dTMS) targeting the medial prefrontal cortex (MPFC) will be delivered using an H7 coil at 20 Hz for 2 seconds per cycle, followed by a 20-second pause, resulting in a 22-second cycle duration, repeated 50 times for a total of 2000 pulses.
ERP
Patients are admitted to a residential program that includes nonverbal therapies, cognitive behavioural therapy, and from week 3 onward, weekly Exposure Relapse Prevention (ERP) sessions (3 hours/week for 8 weeks; total admission = 10 weeks). ERP includes an inventory of OCD symptoms, psychoeducation on the difference between obsessions and compulsions using an OCD model, and the creation of a stepwise fear hierarchy with exposure and response prevention exercises. Patients practice both during and outside sessions, including at home on weekends. Family involvement is integrated: relatives are invited every three weeks to receive psychoeducation on OCD and ERP, are informed about accommodation behaviors, and may attend a session.
iTBS + ERP
20 hospitalized patients who will receive a specific form of repetitive transcranial magnetic stimulation: intermittent thetaburst stimulation (iTBS) with F8 coil; next to psychofarmacological treatment and exposure responseprevention for OCD.
iTBS
Intermittent theta burst stimulation (iTBS) targeting the left Dorsolateral Prefrontal Cortex (LDLPFC) will be delivered using a figure-of-eight coil at 50 Hz (3 pulses per burst, 5 Hz burst frequency), with 10 bursts over 2 seconds, followed by an 8-second pause, resulting in a 10-second cycle duration, repeated 60 times for a total of 1800 pulses.
ERP
Patients are admitted to a residential program that includes nonverbal therapies, cognitive behavioural therapy, and from week 3 onward, weekly Exposure Relapse Prevention (ERP) sessions (3 hours/week for 8 weeks; total admission = 10 weeks). ERP includes an inventory of OCD symptoms, psychoeducation on the difference between obsessions and compulsions using an OCD model, and the creation of a stepwise fear hierarchy with exposure and response prevention exercises. Patients practice both during and outside sessions, including at home on weekends. Family involvement is integrated: relatives are invited every three weeks to receive psychoeducation on OCD and ERP, are informed about accommodation behaviors, and may attend a session.
Control (ERP)
20 hospitalized patiënts who will receive psychofarmacological treatment and exposure responseprevention for OCD. No TMS.
ERP
Patients are admitted to a residential program that includes nonverbal therapies, cognitive behavioural therapy, and from week 3 onward, weekly Exposure Relapse Prevention (ERP) sessions (3 hours/week for 8 weeks; total admission = 10 weeks). ERP includes an inventory of OCD symptoms, psychoeducation on the difference between obsessions and compulsions using an OCD model, and the creation of a stepwise fear hierarchy with exposure and response prevention exercises. Patients practice both during and outside sessions, including at home on weekends. Family involvement is integrated: relatives are invited every three weeks to receive psychoeducation on OCD and ERP, are informed about accommodation behaviors, and may attend a session.
Interventions
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iTBS
Intermittent theta burst stimulation (iTBS) targeting the left Dorsolateral Prefrontal Cortex (LDLPFC) will be delivered using a figure-of-eight coil at 50 Hz (3 pulses per burst, 5 Hz burst frequency), with 10 bursts over 2 seconds, followed by an 8-second pause, resulting in a 10-second cycle duration, repeated 60 times for a total of 1800 pulses.
dTMS
Deep TMS (dTMS) targeting the medial prefrontal cortex (MPFC) will be delivered using an H7 coil at 20 Hz for 2 seconds per cycle, followed by a 20-second pause, resulting in a 22-second cycle duration, repeated 50 times for a total of 2000 pulses.
ERP
Patients are admitted to a residential program that includes nonverbal therapies, cognitive behavioural therapy, and from week 3 onward, weekly Exposure Relapse Prevention (ERP) sessions (3 hours/week for 8 weeks; total admission = 10 weeks). ERP includes an inventory of OCD symptoms, psychoeducation on the difference between obsessions and compulsions using an OCD model, and the creation of a stepwise fear hierarchy with exposure and response prevention exercises. Patients practice both during and outside sessions, including at home on weekends. Family involvement is integrated: relatives are invited every three weeks to receive psychoeducation on OCD and ERP, are informed about accommodation behaviors, and may attend a session.
Eligibility Criteria
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Inclusion Criteria
* Hospitalization for Obsessive-Compulsive Disorder (OCD)
* Participation in Exposure and Response Prevention Therapy
* Significant OCD, as measured by a Y-BOCS score of 20 or higher (moderate to severe OCD symptoms)
Exclusion Criteria
* Psychotic disorder: patients with active psychotic disorders are excluded due to the complexity of their condition and potential interactions with the study protocol.
* Current substance use disorder: active substance use disorders are exclusionary to prevent confounding effects on study outcomes.
* Deep Brain Stimulation (DBS) for OCD: participants with an implanted DBS device for OCD are excluded due to potential interference with the study's interventions and safety concerns.
18 Years
65 Years
ALL
No
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Dienstpsychiatrie
Prof. Dr. Chris Baeken
Principal Investigators
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Chris Baeken, PhD. MD. Psychiatry
Role: PRINCIPAL_INVESTIGATOR
UZ GENT
Locations
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UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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ONZ-2022-0372 AM02 dd 07-Mar-2
Identifier Type: -
Identifier Source: org_study_id
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