Obsessive Compulsive Disorder (OCD)NCT06596447
Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
A study testing Deep Brain Stimulation in people with Obsessive Compulsive Disorder (OCD) and Neuromodulation, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability. Read more about this study
- Who is it for?
- Ages 22 to 64 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Neuromodulation
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 31 Jul 2030
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Principal diagnosis of OCD per DSM-5;
- Adult between ages 22 and 64;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Minimum score of 28 on the Y-BOCS;
- Failed an adequate trial of at least three SSRIs;
- Failed an adequate trial of clomipramine;
Show all 12Show fewer
- Failed augmentation of one or more of the aforementioned drugs with at least one anti-psychotic medication;
- Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- Stable psychotropic medical regimen for the month preceding surgery;
- Principal diagnosis of OCD who are approved by our multi-disciplinary team to undergo DBS surgery within two months of enrollment;
- Ability to provide fully informed, written consent;
- Availability of a family member or significant other who is willing to accompany patients to study visits if necessary.
Who cannot join
- Lifetime diagnosis of psychotic disorder such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Concern for high risk of suicidal behavior or impulsivity;
- Patient is [regnant or plans to become pregnant in the next 24 months;
- Need for diathermy;
- Existence of any neurological or medical condition/disorder that makes the individual, in the opinion of the study team, a poor candidate to participate in the intended study procedures
- Comorbid psychiatric disorder that, in the opinion of the study team, may interfere with the candidate's ability to participate in study activities;
- Primary diagnosis of a Hoarding Disorder.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Nicole Provenza, PhD, nprovenz@bcm.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Victoria Gates, 713-798-4060, victoria.gates@bcm.edu
About this study
We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability.
We will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab/clinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms.
Read more
Subjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2).
At home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.
- Being tested
- Deep Brain Stimulation
- Keywords
- Obsessive Compulsive Disorder, OCD, Deep Brain Stimulation, DBS
- 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.
Deep Brain StimulationDevice
While most patients with obsessive compulsive disorder (OCD) eventually respond to treatment with medication and/or behavioral therapy, a small minority do not improve following all conventional treatments. Obsessive-compulsive disorder (OCD) can sometimes be difficult to treat with medication and psychotherapy. For these patients, in this study, we employ deep brain stimulation (DBS), an advanced surgical treatment that uses electrical impulses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Treatment Resistance OCD | Experimental | Not described Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in OCD symptoms
Response will be defined as 35% decrease in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from baseline. The range is from 0 to 40 with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms, and 32-40 extreme symptoms.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nicole Provenza, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596447
- Sponsor's protocol ID
- H-56119
- Other IDs
- R01MH139889
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
- ClinicalTrials.gov ID
- NCT06596447
- Acronym / sponsor ID
- H-56119
- Keywords
- Obsessive Compulsive Disorder, OCD, Deep Brain Stimulation, DBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 19 Sep 2024 (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.
We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability.
We will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab/clinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms.
Subjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2).
At home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Treatment Resistance OCD | Experimental | Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Principal diagnosis of OCD per DSM-5;
- Adult between ages 22 and 64;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Minimum score of 28 on the Y-BOCS;
- Failed an adequate trial of at least three SSRIs;
Key exclusion criteria (8 listed)
- Lifetime diagnosis of psychotic disorder such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Concern for high risk of suicidal behavior or impulsivity;
- Patient is [regnant or plans to become pregnant in the next 24 months;
- Need for diathermy;
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 |
|---|---|---|
| Deep Brain StimulationWhile most patients with obsessive compulsive disorder (OCD) eventually respond to treatment with medication and/or behavioral therapy, a small minority do not improve following all conventional treatments. Obsessive-compulsive disorder (OCD) can sometimes be difficult to treat with medication and psychotherapy. For these patients, in this study, we employ deep brain stimulation (DBS), an advanced surgical treatment that uses electrical impulses. | Device | Patients with Treatment Resistance OCD |
Primary outcome
Changes in OCD symptoms
Time frame: 14 months
Response will be defined as 35% decrease in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from baseline. The range is from 0 to 40 with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms, and 32-40 extreme symptoms.
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 23 Jul 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Obsessive Compulsive Disorder (OCD) and Neuromodulation, run by Baylor College of Medicine 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 12 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. 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?
Contact Nicole Provenza, PhD (713-798-5060, nprovenz@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in OCD symptoms (time frame: 14 months). 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 23 Jul 2026.