Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

OCD Clinical Trial

Official title:

Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404609
• Other study ID #: 43421
• Status: Completed
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: April 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80

• Primary diagnosis of OCD

• Sufficient severity of OCD symptoms

• Capacity to provide informed consent

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

Related Conditions & MeSH terms

• OCD

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Williams NR, Sudheimer KD, Cole EJ, Varias AD, Goldstein-Piekarski AN, Stetz P, Lombardi A, Filippou-Frye M, van Roessel P, Anderson K, McCarthy EA, Wright B, Sandhu T, Menon S, Jo B, Koran L, Williams LM, Rodriguez CI. Accelerated neuromodulation therapy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.	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.	Baseline and up to two weeks

External Links

•   Rodriguez Lab