Obsessive-Compulsive DisorderPERFECT DBSNCT03244852
Patient-specific, Effective, and Rational Functional Connectivity Targeting for DBS in OCD
An observational study of Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The study aims to improve patient-specific anatomical targeting of the Deep Brain Stimulation for the treatment of intractable OCD. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects will be 11 patients with DSM-5-defined OCD of disabling severity, refractory to prolonged treatment trials with conventional medication and behavioral therapy, who would therefore otherwise be candidates for psychiatric neurosurgery.
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 64 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent.
- Approved to be implanted with a DBS device for OCD.
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.
- A clinical history of bipolar mood disorder; substance-induced mania is not an exclusion.
- 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).
- 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.
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- 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 disorder.
- Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation
- Past or present diagnosis of hoarding disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
The study aims to improve patient-specific anatomical targeting of the Deep Brain Stimulation for the treatment of intractable OCD.
Read the detailed description
Recently, deep brain stimulation (DBS) has emerged as a potentially circuit-specific treatment for intractable OCD. DBS is programmable, allowing the clinician to "reshape" the volume of tissue activated within the standard ventral capsule/ventral striatum (VC/VS) target.
However, VC/VS DBS' efficacy is limited by two major factors: imperfect targeting and a lack of decision rules for stimulation adjustment. The VC/VS target is not a single identifiable structure, but encompasses white matter of the internal capsule and gray matter of the nucleus accumbens (NAc). In current practice for DBS in OCD, all patients are implanted at standard x,y,z coordinates in the VC/VS region. Due to this inter-subject anatomical variability, different fiber tracts are stimulated by ostensibly the "same" parameters in each subject, leading to variable outcomes. This investigation will identify aspects of VC/VS circuitry that may determine clinical response. The hypothesis is that good clinical outcomes may correlate to electrical field capture of either striatal gray matter or of white matter fibers connecting OFC to thalamus.
The current study looks to extend the neuroimaging investigation using anatomic white matter targeting, functional gray matter targeting and changes in changes in regional glucose metabolism of Deep Brain Stimulation (DBS) in severe obsessive-compulsive disorder (OCD) with the long-term aim of identifying biomarkers that could improve outcomes of this expensive and invasive therapy. Improved imaging would allow surgeons to place the DBS lead closer to the biological targets, thus improving efficacy of the treatment.
The objectives of this study are threefold:
- Improve the anatomic white matter targeting of the Deep Brain Stimulator (DBS) implant by tracing and identifying fibers of passage within the Ventral Capsule (VC) white matter using advance tractography methods in preoperative diffusion MRI data.
- Improve functional gray matter targeting by studying the overlap of the volume of tissue activated (VTA) with the VC voxels of maximal preoperative connectivity to the orbitofrontal cortex (OFC)
- Determine the changes in regional glucose metabolism using preoperative and post-treatment FDG-PET (Positron Emission Tomography) following 3 months of DBS treatment
- Conditions
- Obsessive-Compulsive Disorder
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OCD Patients with Deep Brain Stimulators | Patients with deep brain stimulation for intractable obsessive compulsive disorder (OCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure to correlate OCD symptoms severity.
Measured: 6 months
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (1)
Clinical improvement (change in YBOCS from baseline) will be correlated with the degree of postoperative capture of OFC fibers in the VTA of the active DBS contact
Measured: 6 months
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (2)
Clinical improvement (change in YBOCS from baseline) will be correlated with overlap of the volume of tissue activated (VTA) with the identified ventral striatum voxels of maximal preoperative connectivity to the OFC.
Measured: 6 months
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (3)
Clinical improvement (change in YBOCS from baseline) will be correlated with changes in regional glucose metabolism in the OFC, caudate, and thalamus.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start15 Sep 2017
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: Data was analyzed from a previously collected dataset so no new participants were enrolled.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 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
- NCT03244852
- Sponsor's protocol ID
- 2017P000882
- Acronym
- PERFECT DBS
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2017
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific, Effective, and Rational Functional Connectivity Targeting for DBS in OCD
- ClinicalTrials.gov ID
- NCT03244852
- Acronym / sponsor ID
- PERFECT DBS / 2017P000882
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, deep brain stimulation, treatment-resistant OCD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Data was analyzed from a previously collected dataset so no new participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Aug 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.
The study aims to improve patient-specific anatomical targeting of the Deep Brain Stimulation for the treatment of intractable OCD.
Detailed description
Recently, deep brain stimulation (DBS) has emerged as a potentially circuit-specific treatment for intractable OCD. DBS is programmable, allowing the clinician to "reshape" the volume of tissue activated within the standard ventral capsule/ventral striatum (VC/VS) target.
However, VC/VS DBS' efficacy is limited by two major factors: imperfect targeting and a lack of decision rules for stimulation adjustment. The VC/VS target is not a single identifiable structure, but encompasses white matter of the internal capsule and gray matter of the nucleus accumbens (NAc). In current practice for DBS in OCD, all patients are implanted at standard x,y,z coordinates in the VC/VS region. Due to this inter-subject anatomical variability, different fiber tracts are stimulated by ostensibly the "same" parameters in each subject, leading to variable outcomes. This investigation will identify aspects of VC/VS circuitry that may determine clinical response. The hypothesis is that good clinical outcomes may correlate to electrical field capture of either striatal gray matter or of white matter fibers connecting OFC to thalamus.
The current study looks to extend the neuroimaging investigation using anatomic white matter targeting, functional gray matter targeting and changes in changes in regional glucose metabolism of Deep Brain Stimulation (DBS) in severe obsessive-compulsive disorder (OCD) with the long-term aim of identifying biomarkers that could improve outcomes of this expensive and invasive therapy. Improved imaging would allow surgeons to place the DBS lead closer to the biological targets, thus improving efficacy of the treatment.
The objectives of this study are threefold:
- Improve the anatomic white matter targeting of the Deep Brain Stimulator (DBS) implant by tracing and identifying fibers of passage within the Ventral Capsule (VC) white matter using advance tractography methods in preoperative diffusion MRI data.
- Improve functional gray matter targeting by studying the overlap of the volume of tissue activated (VTA) with the VC voxels of maximal preoperative connectivity to the orbitofrontal cortex (OFC)
- Determine the changes in regional glucose metabolism using preoperative and post-treatment FDG-PET (Positron Emission Tomography) following 3 months of DBS treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCD Patients with Deep Brain Stimulators | – | –Patients with deep brain stimulation for intractable obsessive compulsive disorder (OCD) |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be 11 patients with DSM-5-defined OCD of disabling severity, refractory to prolonged treatment trials with conventional medication and behavioral therapy, who would therefore otherwise be candidates for psychiatric neurosurgery.
Key inclusion criteria (6 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 64 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent.
Key exclusion criteria (14 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.
- A clinical history of bipolar mood disorder; substance-induced mania is not an exclusion.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: 6 months
Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure to correlate OCD symptoms severity.
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (1)
Time frame: 6 months
Clinical improvement (change in YBOCS from baseline) will be correlated with the degree of postoperative capture of OFC fibers in the VTA of the active DBS contact
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (2)
Time frame: 6 months
Clinical improvement (change in YBOCS from baseline) will be correlated with overlap of the volume of tissue activated (VTA) with the identified ventral striatum voxels of maximal preoperative connectivity to the OFC.
Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (3)
Time frame: 6 months
Clinical improvement (change in YBOCS from baseline) will be correlated with changes in regional glucose metabolism in the OFC, caudate, and thalamus.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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. This study is not recruiting at the moment.
Cristina Cusin, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by Massachusetts General Hospital 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 6 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: withdrawn, as of the sponsor's last update on 12 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 6 months). The study lists 4 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 12 Dec 2025.