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Device

Neurostimulation 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
The patient has failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
Principal diagnosis of OCD, confirmed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 14 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Obsessive-Compulsive Disorder

OBSESS Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have tried a type of therapy called CBT for OCD, where you had at least 20 sessions with a therapist who specializes in exposure and response prevention (ERP).
Select...
You have had severe OCD (obsessive-compulsive disorder) for at least five years, and it has not responded to previous treatments. It causes a lot of distress and makes it difficult for you to live your life normally.
Select...
You have symptoms of depression that are caused by your OCD and have a score of at least 16 on a depression assessment.
Select...
You have already tried a sufficient amount of clomipramine (a medication) and it did not work for you.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
143 Previous Clinical Trials
44,254 Total Patients Enrolled
University of MinnesotaOTHER
1,336 Previous Clinical Trials
1,544,427 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
110 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
981 Previous Clinical Trials
5,995,172 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
987 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?
Did not meet criteria
Met 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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