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Completed

NCT Number: NCT03404609

Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

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

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Key information

Conditions

OCD

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2018
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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