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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

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date September 12, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 10, 2018)
  • Functional connectivity [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using resting state fMRI
  • Structural connectivity [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using diffusion tensor imaging (DTI) MRI
  • 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)
  • Neurotransmitter concentrations [ Time Frame: Baseline and 12 weeks (i.e. post-treatment) ]
    Measured using magnetic resonance spectroscopy (MRS)
  • Planning [ Time Frame: Baseline, 12 weeks (i.e. post-treatment) ]
    Measured using Tower of London cognitive task
  • Response inhibition [ Time Frame: Baseline, 12 weeks (i.e. post-treatment) ]
    Measured using the stop-signal cognitive task
  • 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
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TMS-induced Plasticity Improving Cognitive Control in OCD
Official Title  ICMJE Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE Device: Repetitive transcranial magnetic stimulation
Non invasive brain stimulation
Other Name: rTMS, TMS
Study Arms  ICMJE
  • Experimental: rTMS condition 1
    Intervention: Device: Repetitive transcranial magnetic stimulation
  • Experimental: rTMS condition 2
    Intervention: Device: Repetitive transcranial magnetic stimulation
  • Experimental: rTMS condition 3
    Intervention: Device: Repetitive transcranial magnetic stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667807
Other Study ID Numbers  ICMJE 91717306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party O.A. van den Heuvel, VU University Medical Center
Study Sponsor  ICMJE VU University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VU University Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP