NCT03404609

Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

Completed NA Results posted Last updated 14 May 2021

What this trial tests

NA trial testing MagPro X100 by MagVenture in OCD in 7 participants. Completed in 1 July 2019.

Timeline

25 August 2018

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	25 August 2018
Primary completion	1 July 2019
Estimated completion	1 July 2019
Sites	1 location across United States

Drugs / interventions tested

• MagPro X100 by MagVenture

Conditions studied

• OCD — all drugs for OCD →

Sponsor

Stanford University

Who can join

Adults 18 to 80, any sex, with OCD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. Primary · 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.

Group	Value	95% CI
rTMS	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline and through study completion (e.g., up to approximately 4 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

rTMS

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (2 terms — click to expand)

Reaction	System	rTMS
headache	Nervous system disorders	—
Fatigue	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03404609 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Accelerated neuromodulation therapy for Obsessive-Compulsive Disorder.
   Williams NR, Sudheimer KD, Cole EJ, Varias AD, et al · · 2021 · cited 34× · PMID 33631349 · DOI 10.1016/j.brs.2021.02.013