Obsessive Compulsive DisorderNCT03184454
Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder
A study testing Medtronic Percept Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of 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 Deep Brain Stimulation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 31 Oct 2026
- 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-5 (SCID-5), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28.
- Persistence of severe symptoms and impairment for five or more years despite: i. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (may use any serotonin or serotonin-norepinephrine inhibitors, but must include a trial of clomipramine) alone or in combination with ii. adequate behavior therapy (≥20 sessions of expert exposure and response prevention; At least 20 sessions of behavioral therapy must be attempted), and iii. augmentation of one of the selective SRIs with a neuroleptic or 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.
- Patient is aware of, able to adhere to, and willing to tolerate the frequency of visits associated with adjustment of the dual-stimulation configuration and/or collection of brain recordings. This will usually mean limitation to patients who live close to the study site.
- Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits.
Who cannot join
- Current or past psychotic disorder.
- Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist. A questionnaire assessing consent comprehension will be used with all study subjects, to ensure that they understand the key procedures of the study, and its risks and benefits. An independent monitor will administer that questionnaire.
- A clinical history of bipolar mood disorder. We will not exclude substance-induced mania or hypomania.
- In our prior studies, a history of induced hypomanic symptoms did not predict DBS-related hypomania.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
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- Any labeled DBS contraindication and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
- Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
- Pregnancy and women of childbearing age not using effective contraception.
- Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
- Clinical history of severe personality disorder.
- Imminent risk of suicide or an inability to control suicide attempts (in the investigators' judgment).
- History of serious suicidal behavior or one or more interrupted suicide attempts with potential lethality judged to result in serious injury or death.
- Diagnosis of body dysmorphic or hoarding disorder.
- Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation or through cognitive screening (MOCA).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Combined Cortical and Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder
This study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of intractable OCD.
Read the detailed description
The goal of this proposal is to provide therapy to patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) by stimulating in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic PC+S deep brain stimulation (DBS) system. While providing this DBS therapy, use of this new, recording-capable device will allow collection of data about brain activity in these two regions. This data will enable researchers to further elucidate the exact mechanisms of DBS therapy, as well as the neuropathophyisiology of OCD. This study aims to 1) gather evidence for corticostriatal changes in OCD in response to acute and chronic VC/VS DBS treatment and 2) specifically disrupt or enhance synchrony in the cortico-striato-thalamo-cortical (CSTC) circuit.
Deep Brain stimulation involves bilateral stereotactic placement of stimulating "leads" into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety). HDE approval was granted in February 2009, and IDE approval was granted in February 2016. Multiple hospitals around the country have established HDE protocols to implant patients with intractable OCD who have failed conventional therapies, and some hospitals, like us, have obtained Investigational Device Exemption (IDE) approval to conduct pilot clinical trials. The existing model of DBS for OCD only addresses one aspect of the brain circuit implicated in the CSTC circuit, the VC/VS target. Therapy with this device, under this protocol, will also be able to provide stimulation to the cortical part of this circuit. Single-site VC/VS DBS may not adequately target the putative circuit. If OCD symptoms do arise from CSTC loop dysfunction, this implies that the problem is one of improper information flow between connected brain areas. Thus, modifying circuit activity may require coordinated intervention at multiple points to effectively synchronize or de-synchronize the full loop. Stimulation that specifically interrupts reverberant activity between prefrontal cortex and striatum will be superior to VC/VS DBS alone at relieving symptoms of OCD. We will test this by simultaneously implanting stimulating/recording electrodes at both VC/VS and a dorsolateral prefrontal cortex (dlPFC) target bilaterally.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Medtronic Percept Deep Brain Stimulation
- Keywords
- OCD, deep brain stimulation, treatment-resistant 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 Deep Brain StimulationDevice
Deep Brain stimulation involves bilateral stereotactic placement of stimulating "leads" into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety).
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Percept Deep Brain Stimulation | Experimental | Single open label arm.
Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system. Receives: Device: Medtronic Percept Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
The Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure for tracking OCD symptoms. We will collect this measure at all clinical visits.
Measured: 2 years
Secondary outcomes (3)
Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) will be a secondary outcome measure for tracking depression symptoms. We will collect this measure at all clinical visits.
Measured: 2 years
Clinical Global Impressions (CGI) Severity and Change scale
The Clinical Global Impressions (CGI) Severity and Change scale will be a secondary outcome measure for tracking global measure of illness severity and change. We will collect this measure at all clinical visits.
Measured: 2 years
Patient Global Impressions (PGI) scale
The Patient Global Impressions (PGI) scale will be a secondary outcome measure for tracking global measure of illness severity and change. We will collect this measure at all clinical visits.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Mar 2019
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cortical and subcortical electrodes
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Cusin, MD, Massachusetts General Hospital
- Investigators
- Cristina Cusin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184454
- Sponsor's protocol ID
- 2015P000456
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Olsen ST, Basu I, Bilge MT, Kanabar A, Boggess MJ, Rockhill AP, Gosai AK, Hahn E, Peled N, Ennis M, Shiff I, Fairbank-Haynes K, Salvi JD, Cusin C, Deckersbach T, Williams Z, Baker JT, Dougherty DD, Widge AS. Case Report of Dual-Site Neurostimulation and Chronic Recording of Cortico-Striatal Circuitry in a Patient With Treatment Refractory Obsessive Compulsive Disorder. Front Hum Neurosci. 2020 Oct 23;14:569973. doi: 10.3389/fnhum.2020.569973. eCollection 2020.
PubMed 33192400
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cortical and Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03184454
- Acronym / sponsor ID
- 2015P000456
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, deep brain stimulation, treatment-resistant OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 12 Jun 2017 (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 study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of intractable OCD.
Detailed description
The goal of this proposal is to provide therapy to patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) by stimulating in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic PC+S deep brain stimulation (DBS) system. While providing this DBS therapy, use of this new, recording-capable device will allow collection of data about brain activity in these two regions. This data will enable researchers to further elucidate the exact mechanisms of DBS therapy, as well as the neuropathophyisiology of OCD. This study aims to 1) gather evidence for corticostriatal changes in OCD in response to acute and chronic VC/VS DBS treatment and 2) specifically disrupt or enhance synchrony in the cortico-striato-thalamo-cortical (CSTC) circuit.
Deep Brain stimulation involves bilateral stereotactic placement of stimulating "leads" into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety). HDE approval was granted in February 2009, and IDE approval was granted in February 2016. Multiple hospitals around the country have established HDE protocols to implant patients with intractable OCD who have failed conventional therapies, and some hospitals, like us, have obtained Investigational Device Exemption (IDE) approval to conduct pilot clinical trials. The existing model of DBS for OCD only addresses one aspect of the brain circuit implicated in the CSTC circuit, the VC/VS target. Therapy with this device, under this protocol, will also be able to provide stimulation to the cortical part of this circuit. Single-site VC/VS DBS may not adequately target the putative circuit. If OCD symptoms do arise from CSTC loop dysfunction, this implies that the problem is one of improper information flow between connected brain areas. Thus, modifying circuit activity may require coordinated intervention at multiple points to effectively synchronize or de-synchronize the full loop. Stimulation that specifically interrupts reverberant activity between prefrontal cortex and striatum will be superior to VC/VS DBS alone at relieving symptoms of OCD. We will test this by simultaneously implanting stimulating/recording electrodes at both VC/VS and a dorsolateral prefrontal cortex (dlPFC) target bilaterally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cortical and subcortical electrodes
| Arm | Type | Receives |
|---|---|---|
| Medtronic Percept Deep Brain Stimulation | Experimental | Device: Medtronic Percept Deep Brain StimulationSingle open label arm. Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- OCD, diagnosed by Structured Clinical Interview for DSM-5 (SCID-5), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28.
- Persistence of severe symptoms and impairment for five or more years despite: i. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (may use any serotonin or serotonin-norepinephrine inhibitors, but must include a trial of clomipramine) alone or in combination with ii. adequate behavior therapy (≥20 sessions of expert exposure and response prevention; At least 20 sessions of behavioral therapy must be attempted), and iii. augmentation of one of the selective SRIs with a neuroleptic or 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 (15 listed)
- Current or past psychotic disorder.
- Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist. A questionnaire assessing consent comprehension will be used with all study subjects, to ensure that they understand the key procedures of the study, and its risks and benefits. An independent monitor will administer that questionnaire.
- A clinical history of bipolar mood disorder. We will not exclude substance-induced mania or hypomania.
- In our prior studies, a history of induced hypomanic symptoms did not predict DBS-related hypomania.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
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 Deep Brain StimulationDeep Brain stimulation involves bilateral stereotactic placement of stimulating "leads" into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety). | Device | Medtronic Percept Deep Brain Stimulation |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: 2 years
The Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure for tracking OCD symptoms. We will collect this measure at all clinical visits.
3 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 2 years
Clinical Global Impressions (CGI) Severity and Change scale
Time frame: 2 years
Patient Global Impressions (PGI) scale
Time frame: 2 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 19 Dec 2025.
- Derived from this study: PubMed 33192400Olsen ST, Basu I, Bilge MT, Kanabar A, Boggess MJ, Rockhill AP, Gosai AK, Hahn E, Peled N, Ennis M, Shiff I, Fairbank-Haynes K, Salvi JD, Cusin C, Deckersbach T, Williams Z, Baker JT, Dougherty DD, Widge AS. Case Report of Dual-Site Neurostimulation and Chronic Recording of Cortico-Striatal Circuitry in a Patient With Treatment Refractory Obsessive Compulsive Disorder. Front Hum Neurosci. 2020 Oct 23;14:569973. doi: 10.3389/fnhum.2020.569973. eCollection 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Cusin, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Percept Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: 2 years). 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 NCT03184454, which also lists 1 linked publication.
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 19 Dec 2025.