Effects of focal non-invasive brain stimulation on network dynamics and symptoms of Obsessive-Compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive Compulsive Disorder; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12616001687482
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-08
• Study Completion: 2022-04-30
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be eligible for participation in the study, male and female participants must meet
all the following criteria:
1. Age: 18-50
2. Diagnosis of primary Obsessive-compulsive disorder (OCD) according to
the DSM-V criteria.
3. Yale and Brown Obsessive Compulsive scale (Y-BOCS) score between
17 and 31 (i.e., moderate to severe symptomatology).
4. Duration of OCD greater than 1 year.
5. Participants must be able to provide informed consent
6. Participants must be available to come to QIMRB daily (Mon-Fri) for 4
weeks. The TMS stimulation will take approximatively 30-45 minutes.

Exclusion Criteria

Potential participants will be ineligible for recruitment if they:
*have had a change to pharmaceutical treatment in the past month.
*are pregnant or trying to fall pregnant?
*ever attempted suicide?
*ever been diagnosed with a psychotic disorder?
*ever experienced a manic episode?
*ever experienced a spontaneous seizure?
*has a neurological disorder?
*ever experienced a traumatic head injury?
*ever been diagnosed with a substance abuse disorder or alcohol/drug misuse?
*suffers from claustrophobia?

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in functional brain connectivity between the striatum and the TMS cortical target assessed using magnetic resonance imaging. The baseline and post-intervention imaging sessions will be used. [ Baseline and 4 weeks];Changes in Y-BOCS score after the TMS intervention. The Y-BOCS is a 10-item scale administered as a semi structured interview. The scale assesses the severity of obsessions and compulsions. The Y-BOCS is the standard test to evaluate OCD. [ Baseline, 4 weeks and 6 months. (The cognitive assessment will take place pre and post TMS intervention, as well as 6 months after the intervention.)];Changes in structural brain connectivity between the striatum and the TMS cortical target assessed using magnetic resonance imaging. The baseline and post-intervention imaging sessions will be used. [ Baseline and 4 weeks]

Secondary Outcome Measures

Name	Time	Method
* Belief domains of the Obsessive Beliefs Questionnaire-44 (OBQ-44)<br><br>[ Baseline, week 4 and 6 months.];*The Obsessive–Compulsive Inventory, short version (OCI-R)[ Baseline, week 4 and 6 months.];*Montgomery Asberg Depression Scale (MADS)[ Baseline, week 4 and 6 months.];*Hamilton Anxiety Rating Scale (HAM_A)[ Baseline, week 4 and 6 months.];*Hospital Anxiety and Depression Scale (HADS)[ Baseline, week 4 and 6 months.];*Weischler Intelligence Scale (WAS-II)[ Baseline, week 4 and 6 months.]