Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

NCT03404609 | Completed Results FDA Device

• 1 other identifier: 43421
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

OCD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Accelerated course of modified continuous theta-burst stimulation (cTBSmod)

EXPERIMENTAL

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.

Device: MagPro X100 by MagVenture

Interventions

MagPro X100 by MagVenture DEVICE

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.

Accelerated course of modified continuous theta-burst stimulation (cTBSmod)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related 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 for Obsessive-Compulsive Disorder. Brain Stimul. 2021 Mar-Apr;14(2):435-437. doi: 10.1016/j.brs.2021.02.013. Epub 2021 Feb 23. No abstract available.

  PMID: 33631349 RESULT

Related Links

• Rodriguez Lab

Limitations and Caveats

This pilot study provides preliminary evidence of the safety, feasibility, and efficacy of a 5-day individualized, accelerated, high-dose, cTBSmod protocol for treatment-refractory OCD. Controlled trials are needed to test these promising findings.

Results Point of Contact

• Title: Dr. Carolyn Rodriguez
• Organization: Stanford University

cr2163@stanford.edu

650-723-6158

Study Officials

• Carolyn Rodriguez, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Nolan Williams, MD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 19, 2018
• Study Start: August 25, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Locations

US (1)