Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

Not Applicable

Completed

• Conditions: OCD
• Interventions: Device: MagPro X100 by MagVenture

• Registration Number: NCT03404609
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to understand how cortical stimulation affects Obsessive-Compulsive Disorder (OCD) symptoms.

Detailed Description

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder

Study Timeline

• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-01-13
• Study First Posted: 2018-01-19
• Study Start: 2018-08-25
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Results First Submitted: 2021-03-26
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Results First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Age 18-80
• Primary diagnosis of OCD
• Sufficient severity of OCD symptoms
• Capacity to provide informed consent

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Exclusion Criteria

• Psychiatric or medical conditions or medications that make participation unsafe
• Pregnant or nursing females
• Previous exposure to TMS or ECT
• History of any implanted device or psychosurgery
• Presence of metallic device or dental braces

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated course of modified continuous theta-burst stimulation (cTBSmod)	MagPro X100 by MagVenture	Participants received 5 consecutive days of accelerated cTBSmod to the right frontal pole. Each cTBSmod session was comprised of 1800 pulses, delivered in a continuous train of 600 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. Ten sessions were applied per day (18,000 pulses/day, hourly) (90,000 total pulses) using a Magventure Magpro X100. Stimulation was delivered at 90% resting motor threshold (depth corrected). Localite Neuronavigation System was used to position the TMS coil over the individualized stimulation target.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.	Baseline and up to two weeks	Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States