TMS-induced Plasticity Improving Cognitive Control in OCD

Not Applicable

Active, not recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Repetitive transcranial magnetic stimulation

• Registration Number: NCT03667807
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Our study aims to compare the clinical and neurobiological effects of three different rTMS stimulation protocols in OCD patients. 8 weeks of rTMS therapy will be delivered in combination with cognitive behavioural therapy. Multimodal neuroimaging will be carried out before and after treatment in order to demonstrate the neurobiological effects of the therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Study Start: 2019-05-08
• Primary Completion: 2022-10-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

OCD patients:

• Age between 18 and 65
• Primary DSM-5 diagnosis of OCD
• Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale - Brown Obsessive Compulsive Scale (YBOCS)
• Unmedicated or stable dose of medication for at least 12 weeks prior to randomisation - with no plans to change dose during the study period
• At least 1 previous attempt at cognitive behavioural therapy (CBT) in lifetime
• At least 1 previous attempt with serotonergic medication or strong preference for non-pharmacological treatment
• Capacity to provide informed consent

Healthy controls (baseline measurements only):

• Age between 18 and 65
• Capacity to provide informed consent

Exclusion Criteria

OCD patients:

• MRI exclusion criteria (metal in body, pregnancy)
• TMS exclusion criteria (metal in body, history of epilepsy)
• Schizophrenia, bipolar disorder, active suicidal ideation, use of antipsychotics within last 12 weeks
• previous experience with rTMS as treatment

Healthy controls:

• Current Diagnostic and Statistical Manual (DSM)-5 diagnosis
• Personal history of DSM-5 diagnosis
• use of psychotropic medications within last 12 months
• 1st degree family member with OCD
• MRI exclusion criteria (as above)
• TMS exclusion criteria (as above)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS condition 1	Repetitive transcranial magnetic stimulation	-
rTMS condition 2	Repetitive transcranial magnetic stimulation	-
rTMS condition 3	Repetitive transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response	Baseline and 12 weeks (i.e. post-treatment)	Change in task based fMRI BOLD response following rTMS

Secondary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)	OCD symptom severity

Trial Locations

Locations (1)

Amsterdam UMC, location VU Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands