Obsessive-Compulsive Disorder (OCD)DBSNCT02773082
DBS for Obsessive-Compulsive Disorder
A study testing Reclaim™ DBS Therapy in people with Obsessive-Compulsive Disorder (OCD), run by Northwell Health at 1 site in United States.
Trial summary
There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- Reclaim™ DBS Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2024to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of OCD with a documented duration of at least 5 years
- Have OCD rated as severe or extreme illness
- Have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs) and clomipramine
- Do not have hoarding as their primary subclassification
- Have completed or tried to complete Exposure and Response Prevention Therapy (ERP)
- Have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality disorder) or current substance abuse issues
Show all 13Show fewer
- Meet established criteria for implantation of a deep brain stimulation system
- Are 18 years old or older
- Have not had a previous surgery to destroy the region of the brain that will be the target of stimulation
- Are not pregnant
- Have no other neurological disorders, including dementia
- Do not have a bleeding disorder or are not taking blood thinners
- Are capable of giving informed consent
Who cannot join
- Patients who are unable to properly operate the neurostimulator
- Patients who will be exposed to diathermy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zucker Hillside Hospital
Queens, New York, 11004
Jenna Schugart, 7184708446, jschugart@northwell.edu
Albert J Fenoy, MD
About this study
Official title: Reclaim™ Deep Brain Stimulation (DBS) Therapy for Obsessive-Compulsive Disorder (OCD)
There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. A rarely used third therapy approach, appropriate for only the most severely afflicted and treatment resistant patients, is neurosurgical ablation of certain brain regions involved in mood and anxiety. The neurosurgical ablation procedures are irreversible in nature, and involve the destruction of specific volumes of brain tissue through various controlled means.
Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a combination of the first two procedures and capsulotomy. DBS therapy is an alternative to neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic, severe OCD which has proven resistant to primary pharmacological and/or behavior therapy options.
Results from 26 severe, treatment-resistant OCD patients treated with DBS at four collaborating centers, three in the US, and one in Europe are summarized in great detail in pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."
Read the detailed description
Procedure The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases.
Sample Size:
There is no minimum number or maximum, but is expected to be far less than 100. Patients that meet the inclusion criteria and will obtain insurance coverage will be candidates for the procedure. As this is not a study on efficacy, there is no statistical analysis to be performed. IRB approval is required per FDA stipulations. Recruitment: Patients who have medically refractory OCD for at least 5 years or more, have failed 3 or more SSRIs, and who meet the criteria for the indications above and are not contraindicated, will attempt to be recruited, or to at least learn more information about the procedure, through the use of flyers. These flyers will attempt to catch the attention of those subjects who may be candidates, and who may benefit from the procedure; only through a more detailed clinic visit would it be know if they meet criteria. The flyers are included as an attachment, and display contact information. They will be posted on line, on free advertising bulletin boards, and in Northwell/Zucker Psychiatry OCD clinics.
Course of Study Patients who are enrolled will meet the necessary requirements/indications for insurance coverage of the system to be implanted.
Aside from these criteria, no specific population will be targeted or else excluded from recruitment. They will sign the informed consent form (attached) prior to surgery if they agree with the course of action. They will be followed for clinical effect and side effects on a routine basis following surgery: after 2 weeks, 1, 2, 3, 4, 6 months and then every 6 months for months, by both the psychiatrist and neurosurgeon. The known risks are detailed in the attached Summary of Safety and Probable Benefit document, Section VIII, as well as the Device manual (attached). All patients enrolled will have their identity safe-guarded, will be issued subject numbers, and personal information will be kept electronically under lock and key in a permanent office.
Data Safety Monitoring As this procedure is nearly identical to that routinely performed here on patients with Parkinson's disease (except that these are different patients and thus a different brain structure is targeted), no specific/independent DSMB will be needed, as there is none currently in use nor needed for the Parkinson's patients. Risks to Clinicians/Researchers There are no known procedures or situations that will provide risks to the clinical/research staff.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- Reclaim™ DBS Therapy
- Keywords
- Treatment-Resistant, Anxiety
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reclaim™ DBS TherapyDevice
DBS is indicated for bilateral stimulation of the ventral anterior limb of the internal capsule as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). Medtronic received humanitarian device exemption (HDE) approval for Reclaim DBS Therapy for the management of OCD on February 19, 2009.
| Study group | Role | What they receive |
|---|---|---|
| Reclaim™ DBS Therapy | Experimental | Procedure:
The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases (using other brain targets). Receives: Device: Reclaim™ DBS Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
The Y-BOCS scale is used to determine severity of OCD and to monitor improvement during treatment. This scale, which measures obsessions separately from compulsions, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of content of obsessions or compulsions present.
The Y-BOCS scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The scale includes questions about the amount of time the patient spends on obsessions, how much impairment or distress they experience, and how much resistance and control they have over these thoughts. The same types of questions are asked about compulsions (e.g., time spent, interference, etc.) as well. The results can be interpreted based on the total score:
0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.
Measured: 1 year
Secondary outcomes (1)
Safety as indicated by the number of Adverse Events
Possible Adverse Events include:
postoperative pain, stress, or discomfort lead repositioning stimulation not effective paresthesia dysarthria disequilibrium paresis intracranial hemorrhage DBS explantation erosion infection component malfunction (IPG, lead, extension) seizures subcutaneous hematoma electrical shocking or jolting headaches allergic reaction burr hole ring and cap failure electrode short circuit or open circuit attention or cognitive deficit, cramping diplopia dysphasia facial weakness neurostimulator changed from cycling mode to continuous mode insufficient oxygenation no connection at "0" electrode broken tunneling rod twelfth cranial nerve palsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start6 Jul 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Albert Fenoy, Northwell Health
- Investigators
- Albert J Fenoy, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773082
- Sponsor's protocol ID
- HSC-MS-09-0520
- Acronym
- DBS
- Status last verified
- Oct 2025
- First submitted
- 11 Jun 2015
- Last updated
- 29 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reclaim™ Deep Brain Stimulation (DBS) Therapy for Obsessive-Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT02773082
- Acronym / sponsor ID
- DBS / HSC-MS-09-0520
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- Treatment-Resistant, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. A rarely used third therapy approach, appropriate for only the most severely afflicted and treatment resistant patients, is neurosurgical ablation of certain brain regions involved in mood and anxiety. The neurosurgical ablation procedures are irreversible in nature, and involve the destruction of specific volumes of brain tissue through various controlled means.
Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a combination of the first two procedures and capsulotomy. DBS therapy is an alternative to neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic, severe OCD which has proven resistant to primary pharmacological and/or behavior therapy options.
Results from 26 severe, treatment-resistant OCD patients treated with DBS at four collaborating centers, three in the US, and one in Europe are summarized in great detail in pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."
Detailed description
Procedure The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases.
Sample Size:
There is no minimum number or maximum, but is expected to be far less than 100. Patients that meet the inclusion criteria and will obtain insurance coverage will be candidates for the procedure. As this is not a study on efficacy, there is no statistical analysis to be performed. IRB approval is required per FDA stipulations. Recruitment: Patients who have medically refractory OCD for at least 5 years or more, have failed 3 or more SSRIs, and who meet the criteria for the indications above and are not contraindicated, will attempt to be recruited, or to at least learn more information about the procedure, through the use of flyers. These flyers will attempt to catch the attention of those subjects who may be candidates, and who may benefit from the procedure; only through a more detailed clinic visit would it be know if they meet criteria. The flyers are included as an attachment, and display contact information. They will be posted on line, on free advertising bulletin boards, and in Northwell/Zucker Psychiatry OCD clinics.
Course of Study Patients who are enrolled will meet the necessary requirements/indications for insurance coverage of the system to be implanted.
Aside from these criteria, no specific population will be targeted or else excluded from recruitment. They will sign the informed consent form (attached) prior to surgery if they agree with the course of action. They will be followed for clinical effect and side effects on a routine basis following surgery: after 2 weeks, 1, 2, 3, 4, 6 months and then every 6 months for months, by both the psychiatrist and neurosurgeon. The known risks are detailed in the attached Summary of Safety and Probable Benefit document, Section VIII, as well as the Device manual (attached). All patients enrolled will have their identity safe-guarded, will be issued subject numbers, and personal information will be kept electronically under lock and key in a permanent office.
Data Safety Monitoring As this procedure is nearly identical to that routinely performed here on patients with Parkinson's disease (except that these are different patients and thus a different brain structure is targeted), no specific/independent DSMB will be needed, as there is none currently in use nor needed for the Parkinson's patients. Risks to Clinicians/Researchers There are no known procedures or situations that will provide risks to the clinical/research staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reclaim™ DBS Therapy | Experimental | Device: Reclaim™ DBS TherapyProcedure: The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases (using other brain targets). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have a diagnosis of OCD with a documented duration of at least 5 years
- Have OCD rated as severe or extreme illness
- Have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs) and clomipramine
- Do not have hoarding as their primary subclassification
- Have completed or tried to complete Exposure and Response Prevention Therapy (ERP)
Key exclusion criteria (2 listed)
- Patients who are unable to properly operate the neurostimulator
- Patients who will be exposed to diathermy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reclaim™ DBS TherapyDBS is indicated for bilateral stimulation of the ventral anterior limb of the internal capsule as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). Medtronic received humanitarian device exemption (HDE) approval for Reclaim DBS Therapy for the management of OCD on February 19, 2009. | Device | Reclaim™ DBS Therapy |
Primary outcome
Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 1 year
The Y-BOCS scale is used to determine severity of OCD and to monitor improvement during treatment. This scale, which measures obsessions separately from compulsions, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of content of obsessions or compulsions present. The Y-BOCS scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The scale includes questions about the amount of time the patient spends on obsessions, how much impairment or distress they experience, and how much resistance and control they have over these thoughts. The same types of questions are asked about compulsions (e.g., time spent, interference, etc.) as well. The results can be interpreted based on the total score: 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.
1 secondary outcome
Safety as indicated by the number of Adverse Events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert J Fenoy, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reclaim™ DBS Therapy in people with Obsessive-Compulsive Disorder (OCD), run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Gonzalez (7184704152, sgonzalez30@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.