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Can a brain implant learn to sense OCD distress and respond in real time?

NCT ID NCT04806516

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests an adaptive deep brain stimulation system for people with severe obsessive-compulsive disorder (OCD) that has not improved with standard treatments. The device, implanted in the brain, aims to detect brain signals linked to OCD distress and adjust its stimulation automatically. Researchers will study 5 adults with hard-to-treat OCD to see if the system can reliably recognize distress and whether it reduces OCD symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive deep brain stimulation using the Summit RC+S system with ECoG paddles
What this could lead to
If it works, this could lead to a smarter brain implant that adjusts stimulation in real time, offering relief for people with severe OCD who have not responded to other treatments.
What could go wrong
This is a very early, small study with only 5 participants. Brain surgery carries risks, and the approach may not reliably detect distress or improve symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent prior to any study specific procedures being performed 2. Male or female between ages 21 and 70; 3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning; 4. A primary diagnosis of OCD with Y-BOCS minimum score of 28; 5. Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine; 6. Failed or could not tolerate an adequate trial of clomipramine; 7. Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole; 8. Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist; 9. Stable psychotropic medical regimen for the month preceding surgery Exclusion Criteria: 1. Inability or refusal to give informed consent. 2. Lifetime diagnosis of psychotic disorders such as schizophrenia; 3. Alcohol or substance abuse/dependence within 6 months, excluding nicotine; 4. Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments. 5. Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate. 6. Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months. 7. Need for Diathermy 8. Contraindications to MRI 9. Contraindications to MEG 10. Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.

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Conditions

The condition(s) this trial relates to.

obsessive-compulsive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obsessive-compulsive disorder

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brown University

    Providence, Rhode Island, 02912, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

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