Obsessive-Compulsive DisorderSEEG-DBS-OCDNCT05623306
SEEG-Guided DBS for OCD
A study testing Stereoencephalography (SEEG) and Deep Brain Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by Casey H. Halpern, M.D. at 2 sites in United States.
Trial summary
This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open-label stimulation for an additional 6 months. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Stereoencephalography (SEEG) and Deep Brain Stimulation (DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2023to 1 Apr 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 22 years and ≤ 75 years of age, at the time of screening
- Chronic (> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
- Presence of obsessions, compulsions, or both
- Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning
- Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition
- Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5
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- Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
- Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the PI
- Adequate trial of ≥ 2 selective serotonin reuptake inhibitors (SSRIs) for an adequate duration at the maximum dose recommended for OCD or at the maximally- tolerated dose according to the FDA-approved package labeling
- Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication
- Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted
- Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP)
- Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least eight weeks prior to study enrollment and for the duration of the trial, as determined by the research/study psychiatrist and the PI
- Willingness and ability to discontinue or refrain from initiating ERP therapy until the maintenance stage, if any, as determined safe by the research/study psychiatrist
- Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of two years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation
- Agreement to being evaluated by a licensed psychiatrist and/or psychologist at regular intervals, as required by the schedule of events, for the duration of study participation
- Living within six hours of driving distance from study sites and no plan of relocation for at least the duration of the trial (approximately 18-24 months), as reported by the prospective subject or a family member
- Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as verifiable emergency contacts
- Willingness and ability to provide at least two verifiable contacts for emergency purposes and to permit verification of emergency contacts by research staff before all study visits and as needed, at the discretion of the PI
- Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the PI
- Willingness and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the PI
- Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
- Willingness and ability to provide informed consent, in the opinion of the PI
Who cannot join
- Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.
- Subjects with secondary psychiatric diagnosis will not be excluded, except as described below.
- In the opinion of the PI and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder
- Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder b. Current/active diagnosis of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder i. Diagnosis will be considered current/active if the subject had an active episode within five years of screening.
- Lifetime diagnosis of a primary psychotic disorder (e.g. Schizophrenia, Schizoaffective Disorder) d. Current/active diagnosis of mood disorder with psychotic features i. Diagnosis will be considered current/active if the subject had an active episode within two years of screening.
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- Acute suicide risk considered significant by any of the following criteria:
- High suicide risk, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) along with clinician assessment; or
- A suicide attempt within the past twelve months that led to hospitalization; or
- Suicide risk that, in the investigator's clinical judgment, necessitates inpatient treatment based on the individual's history and current condition.
- Treatment, within two years of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine
- History of head trauma associated with any of the following:
- Loss of consciousness for > five minutes
- A residual effect(s) that failed to resolve completely at least one year prior to the date of screening
- An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma
- > 1 head injury within the past two years which were diagnosed as a concussion, concussive-type or traumatic brain injury (TBI), according to medical records or as reported by the prospective subject or a family member
- Any of the following permanent implants:
- Cardiac implant (e.g. pacemaker or any intracardiac lines, implanted neurostimulators, shunts)
- Brain implant (e.g. intracranial implant, aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
- Implanted medical pumps
- Diathermy treatments requirement for any reason
- Hearing loss that, in the opinion of the PI, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study or may affect the integrity of the study data
- Any metal or metallic particles anywhere in the head, except in the inside of the mouth
- Pregnancy, at the time of screening or during the course of the study (i.e. three years)
- Acceptable methods of contraception include the following: i. Established use of oral, injected or implanted contraceptives ii. Placement of an intrauterine device (IUD) or an intrauterine system (IUS) iii. Female sterilization (e.g. surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy, tubal ligation) iv. Male sterilization, with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate v. True abstinence, when in line with the preferred and usual lifestyle of the subject b. Barrier methods of contraception, such as a condom, a diaphragm, or cervical/vault caps with spermicidal foam/gel/film/cream/suppository, and rhythm methods of contraception, although encouraged, alone are not considered acceptable forms or contraception.
- History of involuntary movements, in the opinion of the PI or a neuro-radiologist
- History of excessive or prolonged bleeding and/or any of the following:
- INR of > 1.8
- Prolonged activated partial thromboplastin time (aPTT) of ≥ 45 sec
- Platelet count of < 100×100/L
- Allergy to gadolinium
- Inability to safely and successfully undergo an MRI or a CT Scan
- Any past or present medical condition, disease, disorder, or injury that, in the opinion of the PI, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or the results of the study
- Current participation in other research that may potentially interfere with DBS study objectives or with the ability to follow the timeline of this study, as determined by the PI.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Neurosurgery Clinical Research Division, 215-829-6720, npn@uphs.upenn.edu
Marie Kerr, 215-829-6720, marie.kerr@pennmedicine.upenn.edu
- Active, not recruiting
Stanford University
Stanford, California, 94304
About this study
Official title: A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder (SEEG-Guided DBS for OCD)
This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open-label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open-label treatment.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Stereoencephalography (SEEG), Deep Brain Stimulation (DBS)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereoencephalography (SEEG)Device
For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
Deep Brain Stimulation (DBS)Device
For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.
| Study group | Role | What they receive |
|---|---|---|
| ON-OFF (Stimulation-Sham) | Experimental | Participants randomized to the ON-OFF arm will receive active stimulation during the randomization phase for up to 12 weeks. The participants will then have their device turned off and receive sham stimulation during the crossover phase for up to 12 weeks. Receives: Device: Stereoencephalography (SEEG); Device: Deep Brain Stimulation (DBS) |
| OFF-ON (Sham-Stimulation) | Sham comparator | Participants randomized to the OFF-ON arm will have their device turned off and receive sham stimulation during the randomization phase for up to 12 weeks. The participants will then receive active stimulation during the crossover phase for up to 12 weeks. Receives: Device: Stereoencephalography (SEEG); Device: Deep Brain Stimulation (DBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Endpoint #1 - OCD Relevant Network
Percentage of patients in which an OCD relevant network can be identified
Measured: 14 days
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
Percentage of patients in which we can identify a stimulation target that acutely improves OCD symptoms during SEEG Stage 1
Measured: 14 days
Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2
Percentage of patients willing and able to continue with the DBS Stage 2 after completing the SEEG Stage 1
Measured: Day 14
Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement
Percentage of implanted DBS sites associated with both acute symptomatic improvement during the SEEG Stage 1 and therapeutic benefit during the DBS Stage 2.
Measured: Approximately 60 weeks
Primary Efficacy Endpoint - Treatment Response
Treatment response, determined by the difference in Y-BOCS II score between the active stimulation (ON) condition and sham control (OFF) condition
Measured: Up to 24 weeks
Primary Safety Endpoint - Serious Adverse Events
Number and type of serious adverse events in this SEEG-guided 4-lead DBS approach compared to conventional DBS for OCD.
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start13 Apr 2023
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 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 DisorderStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Stage 1: Invasive SEEG Monitoring and Recovery Stage 2: SEEG-Guided DBS Implantation and Optimization of DBS Programming Stage 3: Randomized Sham-Controlled Crossover Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casey H. Halpern, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Pennsylvania, Mayo Clinic, Boston Scientific Corporation, Medtronic
- Responsible party
- Sponsor-investigator, Casey H. Halpern, M.D., University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623306
- Sponsor's protocol ID
- G220185
- Acronym
- SEEG-DBS-OCD
- Status last verified
- May 2026
- First submitted
- 14 Oct 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder (SEEG-Guided DBS for OCD)
- ClinicalTrials.gov ID
- NCT05623306
- Acronym / sponsor ID
- SEEG-DBS-OCD / G220185
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Casey H. Halpern, M.D.University, hospital or other
- Collaborators
- Stanford University, University of Pennsylvania, Mayo Clinic, Boston Scientific Corporation, Medtronic
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 21 Nov 2022 (actual)
- 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.
This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open-label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open-label treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Stage 1: Invasive SEEG Monitoring and Recovery Stage 2: SEEG-Guided DBS Implantation and Optimization of DBS Programming Stage 3: Randomized Sham-Controlled Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| ON-OFF (Stimulation-Sham) | Experimental | Device: Stereoencephalography (SEEG), Device: Deep Brain Stimulation (DBS)Participants randomized to the ON-OFF arm will receive active stimulation during the randomization phase for up to 12 weeks. The participants will then have their device turned off and receive sham stimulation during the crossover phase for up to 12 weeks. |
| OFF-ON (Sham-Stimulation) | Sham comparator | Device: Stereoencephalography (SEEG), Device: Deep Brain Stimulation (DBS)Participants randomized to the OFF-ON arm will have their device turned off and receive sham stimulation during the randomization phase for up to 12 weeks. The participants will then receive active stimulation during the crossover phase for up to 12 weeks. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- ≥ 22 years and ≤ 75 years of age, at the time of screening
- Chronic (> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
- Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
- Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the PI
- Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least eight weeks prior to study enrollment and for the duration of the trial, as determined by the research/study psychiatrist and the PI
Key exclusion criteria (34 listed)
- Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.
- In the opinion of the PI and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder
- Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Acute suicide risk considered significant by any of the following criteria:
- Treatment, within two years of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine
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 |
|---|---|---|
| Stereoencephalography (SEEG)For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions. | Device | OFF-ON (Sham-Stimulation), ON-OFF (Stimulation-Sham) |
| Deep Brain Stimulation (DBS)For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase. | Device | OFF-ON (Sham-Stimulation), ON-OFF (Stimulation-Sham) |
Primary outcome
Primary Feasibility Endpoint #1 - OCD Relevant Network
Time frame: 14 days
Percentage of patients in which an OCD relevant network can be identified
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
Time frame: 14 days
Percentage of patients in which we can identify a stimulation target that acutely improves OCD symptoms during SEEG Stage 1
Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2
Time frame: Day 14
Percentage of patients willing and able to continue with the DBS Stage 2 after completing the SEEG Stage 1
Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement
Time frame: Approximately 60 weeks
Percentage of implanted DBS sites associated with both acute symptomatic improvement during the SEEG Stage 1 and therapeutic benefit during the DBS Stage 2.
Primary Efficacy Endpoint - Treatment Response
Time frame: Up to 24 weeks
Treatment response, determined by the difference in Y-BOCS II score between the active stimulation (ON) condition and sham control (OFF) condition
Primary Safety Endpoint - Serious Adverse Events
Time frame: Approximately 4 years
Number and type of serious adverse events in this SEEG-guided 4-lead DBS approach compared to conventional DBS for OCD.
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 14 May 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereoencephalography (SEEG) and Deep Brain Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by Casey H. Halpern, M.D. at 2 sites 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 23 inclusion and 34 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Neurosurgery Clinical Research Divison (215-829-6720, npn@uphs.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Endpoint #1 - OCD Relevant Network (time frame: 14 days). The study lists 6 primary outcomes in all. 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 14 May 2026.