Obsessive-Compulsive DisorderNCT07303946
Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)
A study testing Medtronic Percept system and 3391 3387 Medtronic DBS electrodes in people with Obsessive-Compulsive Disorder, run by Rhode Island Hospital.
Trial summary
This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Medtronic Percept system and 3391 3387 Medtronic DBS electrodes
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2031
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.
- Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age between 21 and 65 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent in the judgment of the site Consent Monitor.
- Either drug free or on a stable drug regimen for at least 6 weeks.
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- Good general health.
- A family member or significant other, in contact with the patient every 1-3 days, is available and willing to communicate with the research team if the patient's clinical status worsens, and if necessary to accompany patients to study visits.
- The local referring psychiatrist is willing to provide ongoing care during and after the trial
Who cannot join
- personal/family history (1st/2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;
- present PTS;
- present acute suicidality or suicidal ideation;
- personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);
- MMSE score < 24;
- premorbid IQ estimate < 85;
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- visual disturbance (<20/40 Snellen visual acuity, corrected);
- left/mixed handedness;
- current, or alcohol or illicit substance abuse/dependence in the last 3 months, determined by clinical assessment and urine toxicology;
- contraindications to MRI,: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia raising the risk of panicking in enclosed spaces;
- positive pregnancy test for women of reproductive age, or women not using medically acceptable birth control throughout the study (barrier and/or oral contraceptives);
- current psychotic symptoms (potential confounding effect on neuroimaging measures; see above);
- an increased risk of seizure, determined by history;
- 4) potentially proconvulsant medications (e.g., bupropion, tricyclic antidepressants, first-generation antipsychotics, lithium), and medications reducing cortical excitability (e.g., anticonvulsants, benzodiazepines, atypical antipsychotics).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Double-Blind, Crossover, Feasibility Study of Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)
This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.
Read the detailed description
This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained. Following implantation of bilateral Medtronic Percept stimulating and recording electrodes in the ACB with electrode Medtronic 3391 and of bilateral Medtronic 3387 electrodes in participants, they will be entered into a two week baseline period with baseline clinical assessments(see Schedule of Assessments) and imaging. Patients will be randomized into ACB or vALIC arms of the study and enter a two week period of stimulation optimization followed by 12 weeks of active blinded treatment in the first condition and then crossed over to the alternate condition where following discontinuation of the first condition stimulation an additional two week period of stimulation optimization in the alternate condition will be followed by an additional twelve weeks of stimulation in the alternate condition. Primary outcome measures will include the YBOCs-II and the Clinical Global Assessment. Ratings will be obtained by independent raters blind to stimulation condition. Following the completion of the second 12 week blinded period, the patient will enter an open nonblinded study of ACB plus vALIC stimulation.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Medtronic Percept system and 3391 3387 Medtronic DBS electrodes
- Keywords
- deep brain stimulation, intractable OCD
- 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.
Medtronic Percept system and 3391 3387 Medtronic DBS electrodesDevice
Surgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status.
| Study group | Role | What they receive |
|---|---|---|
| ACB | Experimental | DBS of the anterior cingulate bundle (ACB) Receives: Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodes |
| vALIC arms | Experimental | DBS of the ventral anterior limb of the internal capsule (vALIC) Receives: Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Measured: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Measured: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Measured: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Measured: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Measured: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Measured: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
Secondary outcomes (6)
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Measured: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Measured: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Measured: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of the both targets.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Measured: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Measured: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Measured: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Baylor College of Medicine, Butler Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303946
- Sponsor's protocol ID
- 5POMH106435P52
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Crossover, Feasibility Study of Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT07303946
- Acronym / sponsor ID
- 5POMH106435P52
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- deep brain stimulation, intractable OCD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Brown University, Baylor College of Medicine, Butler Hospital
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 26 Dec 2025 (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 blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.
Detailed description
This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained. Following implantation of bilateral Medtronic Percept stimulating and recording electrodes in the ACB with electrode Medtronic 3391 and of bilateral Medtronic 3387 electrodes in participants, they will be entered into a two week baseline period with baseline clinical assessments(see Schedule of Assessments) and imaging. Patients will be randomized into ACB or vALIC arms of the study and enter a two week period of stimulation optimization followed by 12 weeks of active blinded treatment in the first condition and then crossed over to the alternate condition where following discontinuation of the first condition stimulation an additional two week period of stimulation optimization in the alternate condition will be followed by an additional twelve weeks of stimulation in the alternate condition. Primary outcome measures will include the YBOCs-II and the Clinical Global Assessment. Ratings will be obtained by independent raters blind to stimulation condition. Following the completion of the second 12 week blinded period, the patient will enter an open nonblinded study of ACB plus vALIC stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACB | Experimental | Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodesDBS of the anterior cingulate bundle (ACB) |
| vALIC arms | Experimental | Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodesDBS of the ventral anterior limb of the internal capsule (vALIC) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.
- Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age between 21 and 65 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent in the judgment of the site Consent Monitor.
Key exclusion criteria (14 listed)
- personal/family history (1st/2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;
- present PTS;
- present acute suicidality or suicidal ideation;
- personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);
- MMSE score < 24;
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 |
|---|---|---|
| Medtronic Percept system and 3391 3387 Medtronic DBS electrodesSurgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status. | Device | ACB, vALIC arms |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Clinical Global Impression (CGI)
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Clinical Global Impression (CGI)
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Clinical Global Impression (CGI)
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
6 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Global Assessment of Functioning (GAF)
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Global Assessment of Functioning (GAF)
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of the both targets.
Sheehan Disability Scale (SDS)
Time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.
Sheehan Disability Scale (SDS)
Time frame: At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.
Sheehan Disability Scale (SDS)
Time frame: At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.
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 26 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Percept system and 3391 3387 Medtronic DBS electrodes in people with Obsessive-Compulsive Disorder, run by Rhode Island Hospital.
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Owen Leary, BS (401-444-4362, memory.stimulation@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (time frame: At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.). 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 26 Dec 2025.