TMS-induced Plasticity Improving Cognitive Control in OCD

Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)

Sponsors

Lead Sponsor: VU University Medical Center

Source VU University Medical Center
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.

Overall Status Recruiting
Start Date 2019-05-08
Completion Date 2022-11-01
Primary Completion Date 2022-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response Baseline and 12 weeks (i.e. post-treatment)
Secondary Outcome
Measure Time Frame
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)
Enrollment 75
Condition
Intervention

Intervention Type: Device

Intervention Name: Repetitive transcranial magnetic stimulation

Description: Non invasive brain stimulation

Other Name: rTMS, TMS

Eligibility

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Sophie Fitzsimmons

Phone: +31625694905

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Amsterdam UMC, location VU Medical Center O A van den Heuvel, psychiatrist +31-20-4449615 [email protected] O A van den Heuvel, psychiatrist Principal Investigator S Fitzsimmons, MBBCh MSc Sub-Investigator
Location Countries

Netherlands

Verification Date

2020-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: VU University Medical Center

Investigator Full Name: O.A. van den Heuvel

Investigator Title: Professor of Neuropsychiatry

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: rTMS condition 1

Type: Experimental

Label: rTMS condition 2

Type: Experimental

Label: rTMS condition 3

Type: Experimental

Acronym TIPICCO
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obsessive-Compulsive Disorder

Clinical Trials on Repetitive transcranial magnetic stimulation