Obsessive-Compulsive DisorderNCT06347978
Personalized DBS for OCD Guided by Stereoencephalography Mapping
A study testing Deep Brain Stimulation in people with Obsessive-Compulsive Disorder and OCD, run by Andrew Moses Lee, MD, PhD at 1 site in United States.
Trial summary
This is a 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, OCD
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to May 2028
- 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 (> 5 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
Show all 22Show fewer
- 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 all 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 Principal Investigator (PI). Patients may continue to be receiving these following treatments while still enrolled in the study.
- 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)
- Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient
- Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator
- 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 2 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 of every 3 months for the duration of study participation
- Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as a 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 Principal Investigator
- Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator
- 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 Principal Investigator
- 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 Principal Investigator
Who cannot join
- Diagnosed, according to the Mini International Neuropsychiatric Interview (MINI), as suffering from any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder
- In the opinion of the Principal Investigator 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
- Present clinical secondary diagnosis of any of the following, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Bipolar I Disorder or Bipolar II Disorder
- Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder
- Psychotic Disorder or Mood Disorder with psychotic features
Show all 34Show fewer
- Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale [C-SSRS]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt
- Subjects who answer 'Yes' to questions 3, 4, or 5 of the C-SSRS will be excluded and brought by study staff to the nearest emergency room for additional evaluation and psychiatric care.
- Treatment, within 24 months 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 > 5 minutes
- A residual effect(s) that failed to resolve completely at least 1 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 2 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 Principal Investigator, 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. 3 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 uncontrolled or untreated physical, systemic, or metabolic disorders
- Uncontrolled hypertension, defined as systolic > 185 mm Hg and/or diastolic > 110 mmHg and demonstrated on each of three repeated measurements taken within one hour, regardless of whether the patient is taking antihypertensive medications
- History of involuntary movements, which may impact the quality of a neuroimaging study significantly, in the opinion of the Principal Investigator 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 Principal Investigator, 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 Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)
This is a 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 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
Read the detailed description
The study consists of 3 stages.
In Stage 1, the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC, ACC, VC/VS, BNST, and amSTN. The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms. The investigators also intend to record abnormal local field potential (LFP) activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated with OCD symptoms.
In Stage 2, the investigators will use the information obtained during the SEEG Invasive Monitoring phase (Stage 1) to inform the placement of 4 DBS leads using the Medtronic Percept Implantable Pulse Generator system. DBS leads will be targeted to regions identified, in Stage 1, as being associated with symptomatic improvement and OCD-related neural activity. During this phase, the investigators will perform DBS programming to systematically change stimulation parameters to find parameters that optimally relieve patients' OCD symptoms.
In Stage 3, the investigators will then carry out a randomized, controlled, crossover trial to assess the safety, feasibility, and initial efficacy of our SEEG-guided DBS approach for treatment-refractory OCD.
- Conditions
- Obsessive-Compulsive Disorder, OCD
- Being tested
- Deep Brain Stimulation
- 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.
Deep Brain StimulationDevice
Subjects will be randomized to either ON-OFF (Stimulation-Sham) or OFF-ON (Sham-Stimulation) arms. Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.
After completion of the first phase of the trial, patients will undergo another washout phase until they are within 20% of their pre-treatment Y-BOCS II score or 4 weeks have passed, whichever comes first. The purpose of the washout is to eliminate any residual effect of stimulation in the ON group.
Patients will then be advanced to the crossover phase. The participants who were initially randomized to the ON-OFF arm will be moved onto the sham (OFF) period, and the participants who were initially randomized to the OFF-ON group will be moved onto stimulation (ON) period for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ON-OFF (Stimulation-Sham) | Experimental | Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Receives: Device: Deep Brain Stimulation |
| OFF-ON (Sham-Stimulation) | Experimental | Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms
Percentage of patients in which the investigators can identify a stimulation target that acutely improves OCD symptoms during the SEEG Stage 1
Measured: 12 days
Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD
Percentage of patients in which an electrophysiological biomarker of OCD can be identified during the SEEG Stage 1
Measured: 12 days
Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement
Percentage of implanted DBS sites associated with acute symptomatic improvement during the SEEG Stage 1 that also have long-term therapeutic benefit during the DBS Stage 2
Measured: 18 months
Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2
Percentage of enrolled patients completing SEEG Stage 1 and Stage 2 of the trial
Measured: 18 months
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
Primary Efficacy Endpoint - Treatment Response
Treatment response, determined by the difference in Yale-Brown Obsessive Compulsive Scale (YBOCS) II score between the active stimulation (ON) condition and sham control (OFF) condition
Measured: Approximately 4 years
Secondary outcomes (3)
Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline
Responder rates, based on ≥ 35% reduction of baseline Yale-Brown Obsessive Compulsive Scale (YBOCS) I and II scores
Measured: Approximately 4 years
Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline
Reduction of baseline Obsessive-Compulsive Inventory (OCI) score
Measured: Approximately 4 years
Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline
Reduction of baseline Montgomery and Asberg Depression Rating Scale Self Report (MADRS-SR) score
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 posted4 Apr 2024
- Study start24 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Moses Lee, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Moses Lee, MD, PhD, University of California, San Francisco
- Investigators
- A Moses Lee, MD, PhD, Principal investigator, University of California, San FranciscoAndrew Krystal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347978
- Sponsor's protocol ID
- 24-41296
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data may be shared upon request.
Publications
Scangos KW, Makhoul GS, Sugrue LP, Chang EF, Krystal AD. State-dependent responses to intracranial brain stimulation in a patient with depression. Nat Med. 2021 Feb;27(2):229-231. doi: 10.1038/s41591-020-01175-8. Epub 2021 Jan 18.
PubMed 33462446Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
PubMed 19005196Denys D, Graat I, Mocking R, de Koning P, Vulink N, Figee M, Ooms P, Mantione M, van den Munckhof P, Schuurman R. Efficacy of Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Refractory Obsessive-Compulsive Disorder: A Clinical Cohort of 70 Patients. Am J Psychiatry. 2020 Mar 1;177(3):265-271. doi: 10.1176/appi.ajp.2019.19060656. Epub 2020 Jan 7.
PubMed 31906709
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 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 Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)
- ClinicalTrials.gov ID
- NCT06347978
- Acronym / sponsor ID
- 24-41296
- Conditions
- Obsessive-Compulsive Disorder, OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Andrew Moses Lee, MD, PhDUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 4 Apr 2024 (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 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 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
Detailed description
The study consists of 3 stages.
In Stage 1, the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC, ACC, VC/VS, BNST, and amSTN. The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms. The investigators also intend to record abnormal local field potential (LFP) activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated with OCD symptoms.
In Stage 2, the investigators will use the information obtained during the SEEG Invasive Monitoring phase (Stage 1) to inform the placement of 4 DBS leads using the Medtronic Percept Implantable Pulse Generator system. DBS leads will be targeted to regions identified, in Stage 1, as being associated with symptomatic improvement and OCD-related neural activity. During this phase, the investigators will perform DBS programming to systematically change stimulation parameters to find parameters that optimally relieve patients' OCD symptoms.
In Stage 3, the investigators will then carry out a randomized, controlled, crossover trial to assess the safety, feasibility, and initial efficacy of our SEEG-guided DBS approach for treatment-refractory OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON-OFF (Stimulation-Sham) | Experimental | Device: Deep Brain StimulationPatients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. |
| OFF-ON (Sham-Stimulation) | Experimental | Device: Deep Brain StimulationPatients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- ≥ 22 years and ≤ 75 years of age, at the time of screening
- Chronic (> 5 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 all 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 Principal Investigator (PI). Patients may continue to be receiving these following treatments while still enrolled in the study.
- Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator
Key exclusion criteria (34 listed)
- Diagnosed, according to the Mini International Neuropsychiatric Interview (MINI), as suffering from any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder
- In the opinion of the Principal Investigator 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
- Present clinical secondary diagnosis of any of the following, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale [C-SSRS]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt
- Treatment, within 24 months 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 |
|---|---|---|
| Deep Brain StimulationSubjects will be randomized to either ON-OFF (Stimulation-Sham) or OFF-ON (Sham-Stimulation) arms. Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point. After completion of the first phase of the trial, patients will undergo another washout phase until they are within 20% of their pre-treatment Y-BOCS II score or 4 weeks have passed, whichever comes first. The purpose of the washout is to eliminate any residual effect of stimulation in the ON group. Patients will then be advanced to the crossover phase. The participants who were initially randomized to the ON-OFF arm will be moved onto the sham (OFF) period, and the participants who were initially randomized to the OFF-ON group will be moved onto stimulation (ON) period for up to 12 weeks. | Device | OFF-ON (Sham-Stimulation), ON-OFF (Stimulation-Sham) |
Primary outcome
Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms
Time frame: 12 days
Percentage of patients in which the investigators can identify a stimulation target that acutely improves OCD symptoms during the SEEG Stage 1
Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD
Time frame: 12 days
Percentage of patients in which an electrophysiological biomarker of OCD can be identified during the SEEG Stage 1
Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement
Time frame: 18 months
Percentage of implanted DBS sites associated with acute symptomatic improvement during the SEEG Stage 1 that also have long-term therapeutic benefit during the DBS Stage 2
Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2
Time frame: 18 months
Percentage of enrolled patients completing SEEG Stage 1 and Stage 2 of the trial
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.
Primary Efficacy Endpoint - Treatment Response
Time frame: Approximately 4 years
Treatment response, determined by the difference in Yale-Brown Obsessive Compulsive Scale (YBOCS) II score between the active stimulation (ON) condition and sham control (OFF) condition
3 secondary outcomes
Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline
Time frame: Approximately 4 years
Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline
Time frame: Approximately 4 years
Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline
Time frame: Approximately 4 years
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 5 Jun 2026.
- Background: PubMed 33462446Scangos KW, Makhoul GS, Sugrue LP, Chang EF, Krystal AD. State-dependent responses to intracranial brain stimulation in a patient with depression. Nat Med. 2021 Feb;27(2):229-231. doi: 10.1038/s41591-020-01175-8. Epub 2021 Jan 18.
- Background: PubMed 19005196Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
- Background: PubMed 31906709Denys D, Graat I, Mocking R, de Koning P, Vulink N, Figee M, Ooms P, Mantione M, van den Munckhof P, Schuurman R. Efficacy of Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Refractory Obsessive-Compulsive Disorder: A Clinical Cohort of 70 Patients. Am J Psychiatry. 2020 Mar 1;177(3):265-271. doi: 10.1176/appi.ajp.2019.19060656. Epub 2020 Jan 7.
- Individual participant dataSharing planned: No. De-identified data may be shared upon request.
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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. This study is not recruiting at the moment.
A Moses Lee, MD, PhD principal investigator
University of California, San Francisco
Andrew Krystal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Obsessive-Compulsive Disorder and OCD, run by Andrew Moses Lee, MD, PhD 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 22 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms (time frame: 12 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?
On the ClinicalTrials.gov record for NCT06347978, which also lists 3 linked publications.
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 5 Jun 2026.