Obsessive-Compulsive DisorderNCT04958096
Cortical Stimulation to Treat Obsessive Compulsive Disorder
A study testing Standard Therapeutic Deep Brain Stimulation, Cortical Stimulation for PFC and Cortical Stimulation for ACC in people with Obsessive-Compulsive Disorder, run by Andrew Moses Lee, MD, PhD at 1 site in United States.
Trial summary
The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. 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?
- Standard Therapeutic Deep Brain Stimulation, Cortical Stimulation for PFC and Cortical Stimulation for ACC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Aug 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
- Ability to give informed consent for the study
- Age 22-75
- Clinical diagnosis of OCD
- Documented duration of OCD of at least 5 years
- OCD rated as severe or extreme illness (YBOCs ≥ 28)
- Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics
- Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention)
- Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient
Who cannot join
- Has hoarding as a primary subclassification of OCD according to DSM-4
- Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
- Is pregnant
- Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
- Has a cognitive disorder or dementia
- Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
Show all 11Show fewer
- Inability to comply with study follow-up visits
- Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
- Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel).
- Previous cranial ablative or deep brain stimulation surgery.
- Patients may be excluded from enrollment due to a condition that, in the judgement of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107
About this study
Official title: Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)
The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD. The investigators will also investigate whether it is possible for stimulation delivered to these parts of the brain can improve OCD symptoms. These investigations have the potential to aid in the development of improved forms of DBS that can better target abnormal OCD brain signatures in the future.
The investigators will implant a cortical electrode in addition to the ALIC DBS electrode and connect these to an implantable pulse generator that care store field potential data (Medtronic Percept). The decision whether the lead is placed in the prefrontal or cingulate cortex bilaterally will be based upon considerations of the surgical risks for a particular patient based upon their anatomy and the required surgical approach.
At multiple time points post-implantation up to 2 years, in our clinic or patient's homes, cortical and subcortical signals will be recorded. Data will be collected while patient are resting or engaged in symptom provocation tasks, emotional/cognitive tasks while cortical stimulation is on and off. In addition to brain signal recordings, symptoms will be assessed using validated questionnaires and tasks to allow identification of neurophysiological correlates of OCD symptoms.
Read the detailed description
The investigators propose to perform electrophysiological investigations into the corticostriatal circuits mediating severe, refractory obsessive compulsive disorder (OCD) through chronic intracranial recordings and stimulation. This new study will utilize the Medtronic Percept, which is currently is approved for treating OCD under the Humanitarian Device Exemption (HDE).
In addition to their standard therapeutic DBS electrode(s) in the standard subcortical targets (anterior limb of the internal capsule- ALIC), patients enrolled in this study will have a second pair of leads placed in either the prefrontal cortex (PFC) or anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts for a total of 4 DBS leads.
After electrode implantations, patient will undergo 2 phases:
In phase 1 (day 1 - 12 months), the aim will be to identify a biomarker of OCD-related symptoms. Patient will undergo long-term monitoring of their OCD and related psychiatric symptoms along with recordings of cortical and subcortical local field potentials (LFPs). This phase will be conducted in both the outpatient office setting and patient's home environment.
In phase 2 (13 months - 2 years), the investigators will introduce cortical stimulation at either the PFC or ACC/cingulum in addition to stimulation at the ALIC. The investigators will continue to obtain brain recordings and ratings during this period of time to identify the impact of cortical stimulation on these signals.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Standard Therapeutic Deep Brain Stimulation, Cortical Stimulation for PFC, Cortical Stimulation for ACC
- Keywords
- OCD, Obsessive Compulsive Disorder, Obsessive thoughts, Compulsions
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Therapeutic Deep Brain StimulationDevice
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
Cortical Stimulation for PFCDevice
Also called PFC Stimulation
Patients enrolled in this study will have a second pair of leads placed in the prefrontal cortex (PFC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
Cortical Stimulation for ACCDevice
Also called OCD Cortical Stimulation
Patients enrolled in this study will have a second pair of leads placed in the anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
| Study group | Role | What they receive |
|---|---|---|
| Prefrontal Cortex (PFC) | Experimental | The Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC. Receives: Device: Standard Therapeutic Deep Brain Stimulation; Device: Cortical Stimulation for PFC |
| Anterior Cingulate Cortex (ACC) | Experimental | The Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC. Receives: Device: Standard Therapeutic Deep Brain Stimulation; Device: Cortical Stimulation for ACC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months
The Y-BOCS is an OCD symptom scale used for identifying current OCD symptom severity. The score ranges from 0-40, with higher scores indicating more severe OCD symptoms. The change in Y-BOCS score from 12 months to 24 months will be reported.
Measured: 12-24 months
Secondary outcomes (1)
Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months
Effect size of cortical stim + ALIC DBS compared to ALIC DBS (mean difference in Montgomery Asberg Depression Rating Scale (MADRS) score at 12 months and 24 months. Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- Andrew M Lee, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958096
- Sponsor's protocol ID
- 21-33743
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. doi: 10.1016/j.psc.2006.02.013.
PubMed 16650723Denys 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 31906709Swann NC, de Hemptinne C, Thompson MC, Miocinovic S, Miller AM, Gilron R, Ostrem JL, Chizeck HJ, Starr PA. Adaptive deep brain stimulation for Parkinson's disease using motor cortex sensing. J Neural Eng. 2018 Aug;15(4):046006. doi: 10.1088/1741-2552/aabc9b. Epub 2018 May 9.
PubMed 29741160Starr PA. Totally Implantable Bidirectional Neural Prostheses: A Flexible Platform for Innovation in Neuromodulation. Front Neurosci. 2018 Sep 7;12:619. doi: 10.3389/fnins.2018.00619. eCollection 2018.
PubMed 30245616Dougherty DD, Brennan BP, Stewart SE, Wilhelm S, Widge AS, Rauch SL. Neuroscientifically Informed Formulation and Treatment Planning for Patients With Obsessive-Compulsive Disorder: A Review. JAMA Psychiatry. 2018 Oct 1;75(10):1081-1087. doi: 10.1001/jamapsychiatry.2018.0930.
PubMed 30140845Milad MR, Rauch SL. Obsessive-compulsive disorder: beyond segregated cortico-striatal pathways. Trends Cogn Sci. 2012 Jan;16(1):43-51. doi: 10.1016/j.tics.2011.11.003. Epub 2011 Dec 2.
PubMed 22138231Anticevic A, Hu S, Zhang S, Savic A, Billingslea E, Wasylink S, Repovs G, Cole MW, Bednarski S, Krystal JH, Bloch MH, Li CS, Pittenger C. Global resting-state functional magnetic resonance imaging analysis identifies frontal cortex, striatal, and cerebellar dysconnectivity in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):595-605. doi: 10.1016/j.biopsych.2013.10.021. Epub 2013 Nov 4.
PubMed 24314349Saxena S, Brody AL, Maidment KM, Dunkin JJ, Colgan M, Alborzian S, Phelps ME, Baxter LR Jr. Localized orbitofrontal and subcortical metabolic changes and predictors of response to paroxetine treatment in obsessive-compulsive disorder. Neuropsychopharmacology. 1999 Dec;21(6):683-93. doi: 10.1016/S0893-133X(99)00082-2.
PubMed 10633474Nabeyama M, Nakagawa A, Yoshiura T, Nakao T, Nakatani E, Togao O, Yoshizato C, Yoshioka K, Tomita M, Kanba S. Functional MRI study of brain activation alterations in patients with obsessive-compulsive disorder after symptom improvement. Psychiatry Res. 2008 Aug 30;163(3):236-47. doi: 10.1016/j.pscychresns.2007.11.001. Epub 2008 Jul 29.
PubMed 18667293Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. doi: 10.1016/s0193-953x(05)70181-7.
PubMed 10986728Brown LT, Mikell CB, Youngerman BE, Zhang Y, McKhann GM 2nd, Sheth SA. Dorsal anterior cingulotomy and anterior capsulotomy for severe, refractory obsessive-compulsive disorder: a systematic review of observational studies. J Neurosurg. 2016 Jan;124(1):77-89. doi: 10.3171/2015.1.JNS14681. Epub 2015 Aug 7.
PubMed 26252455Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
PubMed 31109199Nauczyciel C, Le Jeune F, Naudet F, Douabin S, Esquevin A, Verin M, Dondaine T, Robert G, Drapier D, Millet B. Repetitive transcranial magnetic stimulation over the orbitofrontal cortex for obsessive-compulsive disorder: a double-blind, crossover study. Transl Psychiatry. 2014 Sep 9;4(9):e436. doi: 10.1038/tp.2014.62.
PubMed 25203167Rao VR, Sellers KK, Wallace DL, Lee MB, Bijanzadeh M, Sani OG, Yang Y, Shanechi MM, Dawes HE, Chang EF. Direct Electrical Stimulation of Lateral Orbitofrontal Cortex Acutely Improves Mood in Individuals with Symptoms of Depression. Curr Biol. 2018 Dec 17;28(24):3893-3902.e4. doi: 10.1016/j.cub.2018.10.026. Epub 2018 Nov 29.
PubMed 30503621Sani OG, Yang Y, Lee MB, Dawes HE, Chang EF, Shanechi MM. Mood variations decoded from multi-site intracranial human brain activity. Nat Biotechnol. 2018 Nov;36(10):954-961. doi: 10.1038/nbt.4200. Epub 2018 Sep 10.
PubMed 30199076
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT04958096
- Acronym / sponsor ID
- 21-33743
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, Obsessive Compulsive Disorder, Obsessive thoughts, Compulsions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Andrew Moses Lee, MD, PhDUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Jul 2021 (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.
The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD. The investigators will also investigate whether it is possible for stimulation delivered to these parts of the brain can improve OCD symptoms. These investigations have the potential to aid in the development of improved forms of DBS that can better target abnormal OCD brain signatures in the future.
The investigators will implant a cortical electrode in addition to the ALIC DBS electrode and connect these to an implantable pulse generator that care store field potential data (Medtronic Percept). The decision whether the lead is placed in the prefrontal or cingulate cortex bilaterally will be based upon considerations of the surgical risks for a particular patient based upon their anatomy and the required surgical approach.
At multiple time points post-implantation up to 2 years, in our clinic or patient's homes, cortical and subcortical signals will be recorded. Data will be collected while patient are resting or engaged in symptom provocation tasks, emotional/cognitive tasks while cortical stimulation is on and off. In addition to brain signal recordings, symptoms will be assessed using validated questionnaires and tasks to allow identification of neurophysiological correlates of OCD symptoms.
Detailed description
The investigators propose to perform electrophysiological investigations into the corticostriatal circuits mediating severe, refractory obsessive compulsive disorder (OCD) through chronic intracranial recordings and stimulation. This new study will utilize the Medtronic Percept, which is currently is approved for treating OCD under the Humanitarian Device Exemption (HDE).
In addition to their standard therapeutic DBS electrode(s) in the standard subcortical targets (anterior limb of the internal capsule- ALIC), patients enrolled in this study will have a second pair of leads placed in either the prefrontal cortex (PFC) or anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts for a total of 4 DBS leads.
After electrode implantations, patient will undergo 2 phases:
In phase 1 (day 1 - 12 months), the aim will be to identify a biomarker of OCD-related symptoms. Patient will undergo long-term monitoring of their OCD and related psychiatric symptoms along with recordings of cortical and subcortical local field potentials (LFPs). This phase will be conducted in both the outpatient office setting and patient's home environment.
In phase 2 (13 months - 2 years), the investigators will introduce cortical stimulation at either the PFC or ACC/cingulum in addition to stimulation at the ALIC. The investigators will continue to obtain brain recordings and ratings during this period of time to identify the impact of cortical stimulation on these signals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefrontal Cortex (PFC) | Experimental | Device: Standard Therapeutic Deep Brain Stimulation, Device: Cortical Stimulation for PFCThe Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC. |
| Anterior Cingulate Cortex (ACC) | Experimental | Device: Standard Therapeutic Deep Brain Stimulation, Device: Cortical Stimulation for ACCThe Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to give informed consent for the study
- Age 22-75
- Clinical diagnosis of OCD
- Documented duration of OCD of at least 5 years
- OCD rated as severe or extreme illness (YBOCs ≥ 28)
Key exclusion criteria (11 listed)
- Has hoarding as a primary subclassification of OCD according to DSM-4
- Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
- Is pregnant
- Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
- Has a cognitive disorder or dementia
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 |
|---|---|---|
| Standard Therapeutic Deep Brain StimulationDBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD | Device | Anterior Cingulate Cortex (ACC), Prefrontal Cortex (PFC) |
| Cortical Stimulation for PFCAlso: PFC StimulationPatients enrolled in this study will have a second pair of leads placed in the prefrontal cortex (PFC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms | Device | Prefrontal Cortex (PFC) |
| Cortical Stimulation for ACCAlso: OCD Cortical StimulationPatients enrolled in this study will have a second pair of leads placed in the anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms | Device | Anterior Cingulate Cortex (ACC) |
Primary outcome
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months
Time frame: 12-24 months
The Y-BOCS is an OCD symptom scale used for identifying current OCD symptom severity. The score ranges from 0-40, with higher scores indicating more severe OCD symptoms. The change in Y-BOCS score from 12 months to 24 months will be reported.
1 secondary outcome
Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months
Time frame: 12-24 months
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 15 Oct 2026.
- Background: PubMed 16650723Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. doi: 10.1016/j.psc.2006.02.013.
- 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.
- Background: PubMed 29741160Swann NC, de Hemptinne C, Thompson MC, Miocinovic S, Miller AM, Gilron R, Ostrem JL, Chizeck HJ, Starr PA. Adaptive deep brain stimulation for Parkinson's disease using motor cortex sensing. J Neural Eng. 2018 Aug;15(4):046006. doi: 10.1088/1741-2552/aabc9b. Epub 2018 May 9.
- Background: PubMed 30245616Starr PA. Totally Implantable Bidirectional Neural Prostheses: A Flexible Platform for Innovation in Neuromodulation. Front Neurosci. 2018 Sep 7;12:619. doi: 10.3389/fnins.2018.00619. eCollection 2018.
- Background: PubMed 30140845Dougherty DD, Brennan BP, Stewart SE, Wilhelm S, Widge AS, Rauch SL. Neuroscientifically Informed Formulation and Treatment Planning for Patients With Obsessive-Compulsive Disorder: A Review. JAMA Psychiatry. 2018 Oct 1;75(10):1081-1087. doi: 10.1001/jamapsychiatry.2018.0930.
- Background: PubMed 22138231Milad MR, Rauch SL. Obsessive-compulsive disorder: beyond segregated cortico-striatal pathways. Trends Cogn Sci. 2012 Jan;16(1):43-51. doi: 10.1016/j.tics.2011.11.003. Epub 2011 Dec 2.
- Background: PubMed 24314349Anticevic A, Hu S, Zhang S, Savic A, Billingslea E, Wasylink S, Repovs G, Cole MW, Bednarski S, Krystal JH, Bloch MH, Li CS, Pittenger C. Global resting-state functional magnetic resonance imaging analysis identifies frontal cortex, striatal, and cerebellar dysconnectivity in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):595-605. doi: 10.1016/j.biopsych.2013.10.021. Epub 2013 Nov 4.
- Background: PubMed 10633474Saxena S, Brody AL, Maidment KM, Dunkin JJ, Colgan M, Alborzian S, Phelps ME, Baxter LR Jr. Localized orbitofrontal and subcortical metabolic changes and predictors of response to paroxetine treatment in obsessive-compulsive disorder. Neuropsychopharmacology. 1999 Dec;21(6):683-93. doi: 10.1016/S0893-133X(99)00082-2.
- Background: PubMed 18667293Nabeyama M, Nakagawa A, Yoshiura T, Nakao T, Nakatani E, Togao O, Yoshizato C, Yoshioka K, Tomita M, Kanba S. Functional MRI study of brain activation alterations in patients with obsessive-compulsive disorder after symptom improvement. Psychiatry Res. 2008 Aug 30;163(3):236-47. doi: 10.1016/j.pscychresns.2007.11.001. Epub 2008 Jul 29.
- Background: PubMed 10986728Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. doi: 10.1016/s0193-953x(05)70181-7.
- Background: PubMed 26252455Brown LT, Mikell CB, Youngerman BE, Zhang Y, McKhann GM 2nd, Sheth SA. Dorsal anterior cingulotomy and anterior capsulotomy for severe, refractory obsessive-compulsive disorder: a systematic review of observational studies. J Neurosurg. 2016 Jan;124(1):77-89. doi: 10.3171/2015.1.JNS14681. Epub 2015 Aug 7.
- Background: PubMed 31109199Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
- Individual participant dataSharing planned: No
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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.
Andrew M Lee, MD, PhD 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 Standard Therapeutic Deep Brain Stimulation, Cortical Stimulation for PFC and Cortical Stimulation for ACC in people with Obsessive-Compulsive Disorder, 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 8 inclusion and 11 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 15 Oct 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?
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months (time frame: 12-24 months). 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 NCT04958096, which also lists 28 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 15 Oct 2026.