Cortical Stimulation to Treat Obsessive Compulsive Disorder
NCT ID: NCT04958096
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2021-08-01
2026-08-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Prefrontal Cortex (PFC)
The Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC.
Standard Therapeutic Deep Brain Stimulation
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
Cortical Stimulation for PFC
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
Anterior Cingulate Cortex (ACC)
The Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC.
Standard Therapeutic Deep Brain Stimulation
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
Cortical Stimulation for ACC
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
Interventions
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Standard Therapeutic Deep Brain Stimulation
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
Cortical Stimulation for PFC
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 ACC
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
22 Years
75 Years
ALL
No
Sponsors
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Andrew Moses Lee, MD, PhD
OTHER
Responsible Party
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Andrew Moses Lee, MD, PhD
Assistant Professor, Psychiatry
Principal Investigators
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Andrew M Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Denys 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.
Swann 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.
Starr 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.
Dougherty 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.
Milad 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.
Anticevic 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.
Saxena 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.
Nabeyama 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.
Saxena 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.
Brown 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.
Carmi 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.
Nauczyciel 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.
Rao 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.
Sani 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.
Bijanki KR, Manns JR, Inman CS, Choi KS, Harati S, Pedersen NP, Drane DL, Waters AC, Fasano RE, Mayberg HS, Willie JT. Cingulum stimulation enhances positive affect and anxiolysis to facilitate awake craniotomy. J Clin Invest. 2019 Mar 1;129(3):1152-1166. doi: 10.1172/JCI120110. Epub 2019 Feb 11.
Swann NC, de Hemptinne C, Miocinovic S, Qasim S, Ostrem JL, Galifianakis NB, Luciano MS, Wang SS, Ziman N, Taylor R, Starr PA. Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in 5 patients with Parkinson's disease. J Neurosurg. 2018 Feb;128(2):605-616. doi: 10.3171/2016.11.JNS161162. Epub 2017 Apr 14.
Shirvalkar P, Veuthey TL, Dawes HE, Chang EF. Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain. Front Comput Neurosci. 2018 Mar 26;12:18. doi: 10.3389/fncom.2018.00018. eCollection 2018.
De Ridder D, Leong SL, Manning P, Vanneste S, Glue P. Anterior Cingulate Implant for Obsessive-Compulsive Disorder. World Neurosurg. 2017 Jan;97:754.e7-754.e16. doi: 10.1016/j.wneu.2016.10.046. Epub 2016 Oct 15.
Burguiere E, Monteiro P, Feng G, Graybiel AM. Optogenetic stimulation of lateral orbitofronto-striatal pathway suppresses compulsive behaviors. Science. 2013 Jun 7;340(6137):1243-6. doi: 10.1126/science.1232380.
Pinhal CM, van den Boom BJG, Santana-Kragelund F, Fellinger L, Bech P, Hamelink R, Feng G, Willuhn I, Feenstra MGP, Denys D. Differential Effects of Deep Brain Stimulation of the Internal Capsule and the Striatum on Excessive Grooming in Sapap3 Mutant Mice. Biol Psychiatry. 2018 Dec 15;84(12):917-925. doi: 10.1016/j.biopsych.2018.05.011. Epub 2018 May 23.
Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.
Swann NC, de Hemptinne C, Miocinovic S, Qasim S, Wang SS, Ziman N, Ostrem JL, San Luciano M, Galifianakis NB, Starr PA. Gamma Oscillations in the Hyperkinetic State Detected with Chronic Human Brain Recordings in Parkinson's Disease. J Neurosci. 2016 Jun 15;36(24):6445-58. doi: 10.1523/JNEUROSCI.1128-16.2016.
Brown JA, Barbaro NM. Motor cortex stimulation for central and neuropathic pain: current status. Pain. 2003 Aug;104(3):431-435. doi: 10.1016/S0304-3959(03)00209-4. No abstract available.
Brown JA, Lutsep H, Cramer SC, Weinand M. Motor cortex stimulation for enhancement of recovery after stroke: case report. Neurol Res. 2003 Dec;25(8):815-8. doi: 10.1179/016164103771953907.
Panov F, Kopell BH. Use of cortical stimulation in neuropathic pain, tinnitus, depression, and movement disorders. Neurotherapeutics. 2014 Jul;11(3):564-71. doi: 10.1007/s13311-014-0283-0.
Kimmelman J, Duckworth K, Ramsay T, Voss T, Ravina B, Emborg ME. Risk of surgical delivery to deep nuclei: a meta-analysis. Mov Disord. 2011 Jul;26(8):1415-21. doi: 10.1002/mds.23770. Epub 2011 May 14.
Panov F, Levin E, de Hemptinne C, Swann NC, Qasim S, Miocinovic S, Ostrem JL, Starr PA. Intraoperative electrocorticography for physiological research in movement disorders: principles and experience in 200 cases. J Neurosurg. 2017 Jan;126(1):122-131. doi: 10.3171/2015.11.JNS151341. Epub 2016 Feb 26.
Other Identifiers
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21-33743
Identifier Type: -
Identifier Source: org_study_id
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