TMS-induced Plasticity Improving Cognitive Control in OCD

Obsessive-Compulsive Disorder Clinical Trial

— TIPICCO  

Official title:

Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03667807
• Other study ID #: 91717306
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: July 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Repetitive transcranial magnetic stimulation
Non invasive brain stimulation

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VU Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional connectivity	Measured using resting state fMRI	Baseline and 12 weeks (i.e. post-treatment)
Other	Structural connectivity	Measured using diffusion tensor imaging (DTI) MRI	Baseline and 12 weeks (i.e. post-treatment)
Other	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)	Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)
Other	Neurotransmitter concentrations	Measured using magnetic resonance spectroscopy (MRS)	Baseline and 12 weeks (i.e. post-treatment)
Other	Planning	Measured using Tower of London cognitive task	Baseline, 12 weeks (i.e. post-treatment)
Other	Response inhibition	Measured using the stop-signal cognitive task	Baseline, 12 weeks (i.e. post-treatment)
Other	Error processing	Measured using the Flanker cognitive task	Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)
Other	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)	Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)
Primary	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	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	OCD symptom severity	Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)