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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Amsterdam UMC, location VU Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

rTMS condition 1

rTMS condition 2

rTMS condition 3

Arm Description

Outcomes

Primary Outcome Measures

task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response
Change in task based fMRI BOLD response following rTMS

Secondary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
OCD symptom severity

Full Information

First Posted
September 6, 2018
Last Updated
May 10, 2023
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT03667807
Brief Title
TMS-induced Plasticity Improving Cognitive Control in OCD
Acronym
TIPICCO
Official Title
Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS condition 1
Arm Type
Experimental
Arm Title
rTMS condition 2
Arm Type
Experimental
Arm Title
rTMS condition 3
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS, TMS
Intervention Description
Non invasive brain stimulation
Primary Outcome Measure Information:
Title
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response
Description
Change in task based fMRI BOLD response following rTMS
Time Frame
Baseline and 12 weeks (i.e. post-treatment)
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
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 Pre-specified Outcome Measures:
Title
Functional connectivity
Description
Measured using resting state fMRI
Time Frame
Baseline and 12 weeks (i.e. post-treatment)
Title
Structural connectivity
Description
Measured using diffusion tensor imaging (DTI) MRI
Time Frame
Baseline and 12 weeks (i.e. post-treatment)
Title
Cortical excitation and inhibition (Motor-evoked potential amplitude, TMS-evoked potential, short interval cortical inhibition, long interval cortical inhibition)
Description
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)
Title
Neurotransmitter concentrations
Description
Measured using magnetic resonance spectroscopy (MRS)
Time Frame
Baseline and 12 weeks (i.e. post-treatment)
Title
Planning
Description
Measured using Tower of London cognitive task
Time Frame
Baseline, 12 weeks (i.e. post-treatment)
Title
Response inhibition
Description
Measured using the stop-signal cognitive task
Time Frame
Baseline, 12 weeks (i.e. post-treatment)
Title
Error processing
Description
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)
Title
EEG measures
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Amsterdam UMC, location VU Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HZ
Country
Netherlands

12. IPD Sharing Statement

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TMS-induced Plasticity Improving Cognitive Control in OCD

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