Actively Recruiting
Reclaim1 Deep Brain Stimulation Therapy for Severe Obsessive-Compulsive Disorder
Led by Northwell Health · Updated on 2025-10-29
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Reclaim1 DBS Therapy as a treatment for adults with severe, treatment-resistant Obsessive-Compulsive Disorder (OCD) who have not improved after multiple medication trials and behavioral therapies. This study compares deep brain stimulation, a neurosurgical procedure, as an alternative to irreversible brain ablation surgeries for people with chronic OCD. The study aims to assess symptom improvement and safety in patients who meet strict criteria for DBS implantation. The treatment involves implanting a DBS lead into a specific brain region called the ventral anterior limb of the internal capsule. This lead is connected to a neurostimulator placed under the skin near the collarbone. The procedure is performed by experienced neurosurgeons using techniques similar to those for other neurological conditions. After surgery, participants will be monitored regularly by psychiatrists and neurosurgeons to assess clinical effects and side effects. Participants will be followed closely for at least one year with scheduled visits at 2 weeks, then monthly to 6 months, and every 6 months thereafter. Researchers will measure changes in OCD symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and track any adverse events. Patient confidentiality is protected through secure data handling. The study does not have a set enrollment size and recruitment includes those who meet insurance coverage and clinical criteria.
CONDITIONS
Brief Title
DBS for Obsessive-Compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of OCD lasting at least 5 years
- OCD rated as severe or extreme illness
- Failed to improve after treatment with at least 3 SSRIs and clomipramine
- Exposure and Response Prevention Therapy (ERP) completed or attempted
- No hoarding as primary subclassification
- No serious additional psychiatric disorders or current substance abuse
- Meet criteria for DBS system implantation
- Age 18 years or older
- No previous brain surgery targeting the stimulation region
- Not pregnant
- No other neurological disorders, including dementia
- No bleeding disorders or blood thinner use
- Able to give informed consent
You will not qualify if you...
- Unable to properly operate the neurostimulator
- Will be exposed to diathermy (a type of physical therapy using deep heating)
- Pregnancy
- Previous brain surgery to the target region
- Serious psychiatric disorders beyond OCD or current substance abuse
- Other neurological disorders including dementia
- Bleeding disorders or blood thinner use
- Inability to provide informed consent or operate the device properly
- Exposure to diathermy treatment during the study period
- Hoarding as the primary subtype of OCD
- Age under 18 years (minor) or pregnancy at enrollment
- Any condition that contraindicates DBS implantation or surgery risks
- Patients who fail insurance or clinical criteria for implantation
- Patients unable to comply with follow-up schedule or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the DBS system by a neurosurgeon. This involves stereotactic placement of the DBS lead in the brain and connection to a neurostimulator implanted under the skin near the collarbone.
1 surgery visit
Duration - Up to 1 year
Participants are followed for clinical effects and side effects by both psychiatrist and neurosurgeon, with visits scheduled frequently initially and then less often over time.
Visits at 2 weeks, 1, 2, 3, 4, 6 months, then every 6 months
Trial Site Locations
Total: 1 location
1
Zucker Hillside Hospital
Queens, New York, United States, 11004
Actively Recruiting
Research Team
S
Samantha Gonzalez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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