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New treatment option for Obsessive Compulsive Disorder (OCD)
Official title Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
ClinicalTrials.gov ID: NCT06596447
What this study is testing
- What it's testing
- We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 64
You may be able to join if
- Principal diagnosis of OCD per DSM-5;
- Adult between ages 18 and 64;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Minimum score of 28 on the Y-BOCS;
- Failed an adequate trial of at least three SSRIs;
You likely can't join if
- Lifetime diagnosis of psychotic disorder such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Concern for high risk of suicidal behavior or impulsivity;
- Patient is [regnant or plans to become pregnant in the next 24 months;
- Need for diathermy;
- Existence of any neurological or medical condition/disorder that makes the individual, in the opinion of the study team, a poor candidate to...
See the full eligibility criteria
- Principal diagnosis of OCD per DSM-5;
- Adult between ages 18 and 64;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Minimum score of 28 on the Y-BOCS;
- Failed an adequate trial of at least three SSRIs;
- Failed an adequate trial of clomipramine;
- Failed augmentation of one or more of the aforementioned drugs with at least one anti-psychotic medication;
- Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- Stable psychotropic medical regimen for the month preceding surgery;
- Principal diagnosis of OCD who are approved by our multi-disciplinary team to undergo DBS surgery within two months of enrollment;
- Ability to provide fully informed, written consent;
- Availability of a family member or significant other who is willing to accompany patients to study visits if necessary.
- Lifetime diagnosis of psychotic disorder such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Concern for high risk of suicidal behavior or impulsivity;
- Patient is [regnant or plans to become pregnant in the next 24 months;
- Need for diathermy;
- Existence of any neurological or medical condition/disorder that makes the individual, in the opinion of the study team, a poor candidate to participate in the intended study procedures
- Comorbid psychiatric disorder that, in the opinion of the study team, may interfere with the candidate's ability to participate in study activities;
- Primary diagnosis of a Hoarding Disorder.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.