OCDNCT03404609

Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

A study testing MagPro X100 by MagVenture in people with OCD, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: OCD
What is being tested?: MagPro X100 by MagVenture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 25 Aug 2018to 1 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

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

Conditions: OCD
Being tested: MagPro X100 by MagVenture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MagPro X100 by MagVentureDevice
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.

Study groups in NCT03404609
Study group	Role	What they receive
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. Receives: Device: MagPro X100 by MagVenture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 20181 Jul 2019

First posted19 Jan 2018
Study start25 Aug 2018
Primary completion1 Jul 2019
Study completion1 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OCDStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03404609
Sponsor's protocol ID: 43421
Status last verified: Apr 2021
First submitted: 13 Jan 2018
Last updated: 14 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All OCD trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rapid Non-Invasive Brain Stimulation for OCD (oTMS)
ClinicalTrials.gov ID: NCT03404609
Acronym / sponsor ID: 43421
Conditions: OCD
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 25 Aug 2018 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Jul 2019 (actual)
First posted: 19 Jan 2018 (actual)
Results: Posted 14 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Accelerated course of modified continuous theta-burst stimulation (cTBSmod)	Experimental	Device: MagPro X100 by MagVentureParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MagPro X100 by MagVentureParticipants 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	Accelerated course of modified continuous theta-burst stimulation (cTBSmod)

Primary outcome

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.

Results and safety

Results posted to the registry on 14 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rTMS	7	7

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

Time frame: Baseline and up to two weeks. Count of participants. Unit: Participants

Measure	rTMS n = 7
Value	4

Adverse events

Time frame: Baseline and through study completion (e.g., up to approximately 4 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rTMS	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33631349Williams 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.
Rodriguez LabLink provided by the sponsor.

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Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
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Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolyn Rodriguez, MD, PhD principal investigator

Stanford University

Nolan Williams, MD study director

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MagPro X100 by MagVenture in people with OCD, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. (time frame: Baseline and up to two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.