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TMS-induced Plasticity Improving Cognitive Control in OCD (TIPICCO)

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ClinicalTrials.gov Identifier: NCT03667807
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
O.A. van den Heuvel, 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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Repetitive transcranial magnetic stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rTMS condition 1 Device: Repetitive transcranial magnetic stimulation
Non invasive brain stimulation
Other Name: rTMS, TMS

Experimental: rTMS condition 2 Device: Repetitive transcranial magnetic stimulation
Non invasive brain stimulation
Other Name: rTMS, TMS

Experimental: rTMS condition 3 Device: Repetitive transcranial magnetic stimulation
Non invasive brain stimulation
Other Name: rTMS, TMS




Primary Outcome Measures :
  1. task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Change in task based fMRI BOLD response following rTMS


Secondary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) ]
    OCD symptom severity


Other Outcome Measures:
  1. Functional connectivity [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using resting state fMRI

  2. Structural connectivity [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using diffusion tensor imaging (DTI) MRI

  3. Cortical excitation and inhibition (Motor-evoked potential amplitude, TMS-evoked potential, short interval cortical inhibition, long interval cortical inhibition) [ Time Frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) ]
    Measured using single and double pulse TMS + electromyography (EMG) / electroencephalography (EEG)

  4. Neurotransmitter concentrations [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using magnetic resonance spectroscopy (MRS)

  5. Planning [ Time Frame: Baseline, 12 weeks (i.e. post-treatment) ]
    Measured using Tower of London cognitive task

  6. Response inhibition [ Time Frame: Baseline, 12 weeks (i.e. post-treatment) ]
    Measured using the stop-signal cognitive task

  7. Error processing [ Time Frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) ]
    Measured using the Flanker cognitive task

  8. EEG measures [ Time Frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) ]
    Resting state EEG, EEG event related potentials measured during tasks (Error related negativity using Flanker task, Late Positive Potential during appraisal of emotional stimuli)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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Responsible Party: O.A. van den Heuvel, Professor of Neuropsychiatry, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03667807     History of Changes
Other Study ID Numbers: 91717306
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders