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Active, not recruitingNCT03667807TIPICCOUpdated May 11, 2023

TMS-induced Plasticity Improving Cognitive Control in OCD

An interventional study of Repetitive transcranial magnetic stimulation in Obsessive-Compulsive Disorder, sponsored by Amsterdam UMC, location VUmc. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obsessive-Compulsive Disorder
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In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's enrollment of 61 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    rTMS condition 1

    Device: Repetitive transcranial magnetic stimulation

  • Experimental
    rTMS condition 2

    Device: Repetitive transcranial magnetic stimulation

  • Experimental
    rTMS condition 3

    Device: Repetitive transcranial magnetic stimulation

Interventions

  • DeviceRepetitive transcranial magnetic stimulation

    Non invasive brain stimulation

    Also known as: rTMS, TMS

06

What researchers measure

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

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

Secondary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    OCD symptom severity

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

Other outcomes

  1. Functional connectivity

    Measured using resting state fMRI

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

  2. Structural connectivity

    Measured using diffusion tensor imaging (DTI) MRI

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

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

    Measured using single and double pulse TMS + electromyography (EMG) / electroencephalography (EEG)

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

  4. Neurotransmitter concentrations

    Measured using magnetic resonance spectroscopy (MRS)

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

  5. Planning

    Measured using Tower of London cognitive task

    Time frame: Baseline, 12 weeks (i.e. post-treatment)

  6. Response inhibition

    Measured using the stop-signal cognitive task

    Time frame: Baseline, 12 weeks (i.e. post-treatment)

  7. Error processing

    Measured using the Flanker cognitive task

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

  8. EEG measures

    Resting state EEG, EEG event related potentials measured during tasks (Error related negativity using Flanker task, Late Positive Potential during appraisal of emotional stimuli)

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

07

Study locations

1 site
  • Amsterdam UMC, location VU Medical Center
    Amsterdam, Noord-Holland 1081 HZ, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03667807
Lead sponsor
Amsterdam UMC, location VUmc
Responsible party
O.A. van den Heuvel (Professor of Neuropsychiatry, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Sep 12, 2018
Start date
May 8, 2019
Primary completion
Oct 1, 2022
Completion
Jul 1, 2023 (estimated)
Last update
May 11, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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