CClinicalTrials.gg
CompletedNCT03404609Updated May 14, 2021Results posted

Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

An interventional study of MagPro X100 by MagVenture in OCD, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • OCD
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

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

    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

  • DeviceMagPro 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.

05

What researchers measure

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.

    Time frame: Baseline and up to two weeks

06

Results

Posted May 14, 2021
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.

Participant flow

Participant flow — Overall Study
MilestonerTMS
Started7
Completed7
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline and up to two weeks
Reported as:
Count of participants · Participants
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
ParticipantsrTMS
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.4

Adverse events

Collected over Baseline and through study completion (e.g., up to approximately 4 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
rTMS0/7 (0%)0/7 (0%)4/7 (57.1%)
Most frequent other events
Most frequent other events
EventrTMS
headacheNervous system disorders4/7
FatigueNervous system disorders3/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)rTMS
Mean40 ± 15
Sex: Female, Male
Sex: Female, Male(Participants)rTMS
Female2
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)rTMS
Hispanic or Latino0
Not Hispanic or Latino7
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)rTMS
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported0
07

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
08

References and documents

Publications

  • 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. PubMed 33631349 ↗

Related links

Study documents

  • Protocol and statistical analysis plan · Apr 22, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03404609
Lead sponsor
Stanford University
Responsible party
Carolyn Rodriguez (Assistant Professor, Stanford University) — Principal investigator
First posted
Jan 19, 2018
Start date
Aug 25, 2018
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019
Results posted
May 14, 2021
Last update
May 14, 2021

Study contacts

Carolyn Rodriguez, MD, PhD
principal investigator · Stanford University
Nolan Williams, MD
study director · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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