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Deep Brain Stimulation for Obsessive-Compulsive Disorder (OBSESS Trial)

N/A
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has failed an adequate trial (150 - 250 mg) of clomipramine
The patient has had at least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 14 months
Awards & highlights

OBSESS Trial Summary

This trial will test whether DBS can reduce symptoms of OCD in a domain-specific manner. The investigators will use Boston Scientific Illumina software to produce imaging-derived inverse solutions to determine the similarity between intracranial electrophysiology-based solutions vs. imaging-based solutions.

Who is the study for?
This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying multiple treatments, including specific antipsychotics and SSRIs, clomipramine, and at least 20 sessions of cognitive-behavioral therapy. Participants must have a significant other to communicate with the research team if needed.Check my eligibility
What is being tested?
The OBSESS Trial is testing a Medtronic Percept RC neurostimulator device in patients with treatment-resistant OCD. It involves implanting DBS leads and temporary sEEG electrodes to personalize stimulation parameters aimed at reducing symptoms.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from surgical procedures, changes in mood or behavior due to brain stimulation, headaches, infection risk at the implant site, and possible unknown long-term effects.

OBSESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried clomipramine without success.
Select...
I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.
Select...
I have tried and not responded to specific antipsychotic drugs.
Select...
I have completed over 20 sessions of a specific therapy for OCD without improvement.
Select...
I have been diagnosed with severe OCD, with a high YBOCS score.
Select...
I am between 21 and 70 years old and not pregnant.
Select...
I have tried at least three SSRIs for 3 months without success.

OBSESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hamilton Depression Inventory (HAM-D) Score
Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score

OBSESS Trial Design

1Treatment groups
Experimental Treatment
Group I: Medtronic Percept RC neurostimulatorExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of HoustonOTHER
147 Previous Clinical Trials
47,466 Total Patients Enrolled
University of MinnesotaOTHER
1,382 Previous Clinical Trials
1,551,297 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
92 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,400 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
750 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Commercially available 8-contact Boston Scientific leads (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05422469 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Medtronic Percept RC neurostimulator
Obsessive-Compulsive Disorder Clinical Trial 2023: Commercially available 8-contact Boston Scientific leads Highlights & Side Effects. Trial Name: NCT05422469 — N/A
Commercially available 8-contact Boston Scientific leads (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for individuals to become eligible to participate in this trial?

"Those suffering from OCD, aged between 21 to 70 years old are eligible for this trial. A total of 12 participants are required in order for it to commence."

Answered by AI

Is this research open to individuals that are of legal age?

"The trial is open to adults ranging from 21-70 years old; those younger or older can take part in 23 and 67 other clinical trials respectively."

Answered by AI

Is this research study currently open to new participants?

"Indications from clinicaltrials.gov suggest that this medical research is not accepting applicants at present. While the original posting was on June 1st, 2023 and it was last updated in mid-June 2022, there are 116 alternate trials actively seeking participants as we speak."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Baylor College of Medicine
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial
Sameer Sheth 2024. "OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422469.
All > Ocd
~8 spots leftby Jan 2029
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