TMS-induced Plasticity Improving Cognitive Control in OCD

NCT ID: NCT03667807

Last Updated: 2023-05-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2023-07-01

Brief Summary

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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

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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rTMS condition 1

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Non invasive brain stimulation

rTMS condition 2

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Non invasive brain stimulation

rTMS condition 3

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Non invasive brain stimulation

Interventions

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Repetitive transcranial magnetic stimulation

Non invasive brain stimulation

Intervention Type DEVICE

Other Intervention Names

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rTMS, TMS

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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O.A. van den Heuvel

Professor of Neuropsychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, location VU Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Fitzsimmons SMDD, Postma T, van Campen AD, Vriend C, Batelaan NM, van Oppen P, Hoogendoorn AW, van der Werf YD, van den Heuvel OA. TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. medRxiv [Preprint]. 2023 Nov 5:2023.11.04.23298100. doi: 10.1101/2023.11.04.23298100.

Reference Type DERIVED
PMID: 37961433 (View on PubMed)

Other Identifiers

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91717306

Identifier Type: -

Identifier Source: org_study_id

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