NCT03667807

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

September 6, 2018

Last Update Submit

May 10, 2023

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response

    Change in task based fMRI BOLD response following rTMS

    Baseline and 12 weeks (i.e. post-treatment)

Secondary Outcomes (1)

  • 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)

Other Outcomes (8)

  • Functional connectivity

    Baseline and 12 weeks (i.e. post-treatment)

  • Structural connectivity

    Baseline and 12 weeks (i.e. post-treatment)

  • Cortical excitation and inhibition (Motor-evoked potential amplitude, TMS-evoked potential, short interval cortical inhibition, long interval cortical inhibition)

    Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)

  • +5 more other outcomes

Study Arms (3)

rTMS condition 1

EXPERIMENTAL
Device: Repetitive transcranial magnetic stimulation

rTMS condition 2

EXPERIMENTAL
Device: Repetitive transcranial magnetic stimulation

rTMS condition 3

EXPERIMENTAL
Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationDEVICE

Non invasive brain stimulation

Also known as: rTMS, TMS
rTMS condition 1rTMS condition 2rTMS condition 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • st degree family member with OCD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location VU Medical Center

Amsterdam, North Holland, 1081 HZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 37961433DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neuropsychiatry

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 12, 2018

Study Start

May 8, 2019

Primary Completion

October 1, 2022

Study Completion

July 1, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

NL(1)