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Obsessive - Compulsive DisorderarTMS-OCDNCT07135414

Accelerated rTMS in Hospitalized Patients With OCD: a Feasibility and Mechanistic Study

A study testing iTBS, dTMS and ERP in people with Obsessive - Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study investigates a new treatment approach for Obsessive-Compulsive Disorder (OCD), a condition characterized by unwanted repetitive thoughts and behaviors. The goal is to determine whether combining specialized inpatient care with repetitive Transcranial Magnetic Stimulation (rTMS) is feasible, well-tolerated… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive - Compulsive Disorder
What is being tested?
iTBS, dTMS and ERP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
25 May 2025to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65
  • 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)

Who cannot join

  • Acute suicidality: Individuals presenting with current suicidal ideation or behavior are excluded to ensure participant safety.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stefanie De Smet, PhD contact

00329 332 43 94

stefanie.desmet@ugent.be

Chris Baeken, PhD. MD. Psychiatry contact

00329 332 43 94

chris.baeken@uzgent.be

Belgium1 site, 1 recruiting
  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Chris Baeken, PhD. MD. Psychiatry, 0032 9 332 43 94, chris.baeken@uzgent.be

    Cisse Geleyn, MD Psychiatry, 00329 332 43 94, cisse.geleyn@uzgent.be

    Recruiting

Other trials in Belgium

About this study

Official title: Accelerated Repetitive Transcranial Magnetic Stimulation in Hospitalized Patients With Obsessive-Compulsive Disorder: a Feasibility and Mechanistic RCT

This study investigates a new treatment approach for Obsessive-Compulsive Disorder (OCD), a condition characterized by unwanted repetitive thoughts and behaviors. The goal is to determine whether combining specialized inpatient care with repetitive Transcranial Magnetic Stimulation (rTMS) is feasible, well-tolerated, and effective. rTMS is a non-invasive procedure that uses magnetic pulses to stimulate specific areas of the brain. In this study, two types of rTMS will be tested: deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both treatments will be administered using an accelerated protocol, involving multiple sessions per day over a two-week period.

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.

Read more

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.

Read the detailed description

This study aims to explore the combination of specialized inpatient care for Obsessive-Compulsive Disorder (OCD) with treatment using repetitive Transcranial Magnetic Stimulation (rTMS) in patients diagnosed with OCD. Specifically, the investigators seek to assess the feasibility, desirability, and tolerability of this combined approach, as well as its clinical and neural effects.

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.

Being tested
iTBS, dTMS, ERP
Keywords
OCD, TMS, deep TMS, iTBS, Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, OCD-TMS, Hospitalized, Hospitalised, dTMS
Medical subject headings
Compulsive Personality Disorder, Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iTBSProcedure or surgery

    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.

  • dTMSProcedure or surgery

    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.

  • ERPBehavioural

    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.

Study groups in NCT07135414
Study groupRoleWhat they receive
dTMS + ERPExperimental20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.
Receives: Procedure: dTMS; Behavioral: ERP
iTBS + ERPExperimental20 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.
Receives: Procedure: iTBS; Behavioral: ERP
Control (ERP)Active comparator20 hospitalized patiënts who will receive psychofarmacological treatment and exposure responseprevention for OCD. No TMS.
Receives: Behavioral: ERP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Reported Severity of Adverse Effects [Safety]

    Severity of specific adverse effects (e.g., headache, tooth pain, scalp discomfort, fatigue, etc.) will be assessed daily using a visual analogue scale (VAS) ranging from 0 (not at all) to 10 (extremely severe). Scores will be collected daily for the duration of the treatment.

    Unit of Measure: VAS score (0-10) per adverse effect

    Measured: From start to end of rTMS treatment period (2 weeks)

  2. Incidence of Any Self-Reported Adverse Effect [Safety]

    Occurrence of any self-reported adverse effect (i.e., VAS > 0 for any symptom) during the rTMS treatment period.

    Unit of Measure: Number of participants reporting ≥1 adverse effect

    Measured: From start to end of rTMS treatment period (2 weeks)

  3. Participant Retention Rate [Feasibility]

    Percentage of participants who complete the full rTMS treatment protocol (32 sessions over 2 weeks) out of those who consented and were randomized.

    Unit of Measure: Percentage of participants completing protocol

    Measured: From enrollment to end of treatment (approximately 2 weeks of rTMS)

Secondary outcomes (6)
  1. Functional MRI-Based Resting-State Functional Connectivity

    Resting-state functional MRI (rs-fMRI) will be used to assess changes in intrinsic brain network connectivity. Whole-brain and region-of-interest (ROI) connectivity analyses will be performed.

    Unit of Measure: Change in functional connectivity (Fisher z-scores or correlation coefficients) between selected brain regions

    Measured: Before and after each treatment arm (2 weeks).

  2. Structural MRI-Based Grey Matter Volume

    Structural MRI scans will be used to estimate grey matter volume in regions implicated in OCD and rTMS target. Voxel-based morphometry and region-specific volumetric analyses will be performed.

    Unit of Measure: Change in grey matter volume in specified regions

    Measured: Before and after each treatment arm (2 weeks).

  3. DTI-Based White Matter Microstructure

    Diffusion Tensor Imaging (DTI) will be used to assess white matter integrity through metrics such as fractional anisotropy (FA) and mean diffusivity (MD). Analyses will focus on tracts implicated in OCD and rTMS targets.

    Unit of Measure: Change in DTI metric values in specified white matter tracts.

    Measured: Before and after each treatment arm (2 weeks).

  4. ASL-Based Resting Cerebral Blood Flow

    Arterial Spin Labeling (ASL) MRI will be used to quantify resting-state cerebral blood flow (CBF) in regions relevant to OCD pathophysiology and rTMS target. Region-of-interest and whole-brain voxelwise analyses will be performed.

    Unit of Measure: Change in CBF in specified brain regions.

    Measured: Before and after each treatment arm (2 weeks).

  5. EEG-Based Resting-State Oscillatory Power

    High-definition EEG will be used to quantify resting-state oscillatory activity in standard frequency bands (delta, theta, alpha, beta, gamma). Unit of Measure: Change in spectral power per frequency band and region.

    Measured: Before and after each treatment arm (2 weeks).

  6. EEG-Based Resting-State Functional Connectivity

    Functional connectivity will be assessed using phase- and coherence-based metrics to evaluate connectivity between cortical regions of interest. Unit of Measure: Change in connectivity strength.

    Measured: Before and after each treatment arm (2 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start25 May 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial (RCT)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07135414
Sponsor's protocol ID
ONZ-2022-0372 AM02 dd 07-Mar-2
Acronym
arTMS-OCD
Status last verified
Aug 2025
First submitted
24 Jul 2025
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing iTBS, dTMS and ERP in people with Obsessive - Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefanie De Smet, PhD (00329 332 43 94, stefanie.desmet@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Severity of Adverse Effects [Safety] (time frame: From start to end of rTMS treatment period (2 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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