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NCT Number: NCT04958096

Cortical Stimulation to Treat Obsessive Compulsive Disorder

The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD. The investigators will also investigate whether it is possible for stimulation delivered to these parts of the brain can improve OCD symptoms. These investigations have the potential to aid in the development of improved forms of DBS that can better target abnormal OCD brain signatures in the future.

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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Key information

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

Location status: Recruiting

Location contact

Andrew M Lee, MD, PhD

CONTACT

[email protected]

415-502-5472

Andrew M Lee, MD, PhD

PRINCIPAL_INVESTIGATOR

Tenzin Norbu, BS

CONTACT

[email protected]

415-514-6489

Tenzin Norbu, BS

SUB_INVESTIGATOR

About this study

The investigators propose to perform electrophysiological investigations into the corticostriatal circuits mediating severe, refractory obsessive compulsive disorder (OCD) through chronic intracranial recordings and stimulation. This new study will utilize the Medtronic Percept, which is currently is approved for treating OCD under the Humanitarian Device Exemption (HDE).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give informed consent for the study
  • 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 hoarding as a primary subclassification of OCD according to DSM-4
  • 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.

Treatment and study plan

Standard Therapeutic Deep Brain Stimulation

Device

DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD

Cortical Stimulation for PFC

Device

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

Other names: PFC Stimulation

Cortical Stimulation for ACC

Device

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 names: OCD Cortical Stimulation

Primary outcomes

  1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months

    Time frame: 12-24 months

    The Y-BOCS is an OCD symptom scale used for identifying current OCD symptom severity. The score ranges from 0-40, with higher scores indicating more severe OCD symptoms. The change in Y-BOCS score from 12 months to 24 months will be reported.

Secondary outcomes

  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months

    Time frame: 12-24 months

    Effect size of cortical stim + ALIC DBS compared to ALIC DBS (mean difference in Montgomery Asberg Depression Rating Scale (MADRS) score at 12 months and 24 months. Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.

Other outcomes

  1. Biomarker identification in Stage 1

    Time frame: 1-12 months

    The number of patients in whom we can identify a neural biomarker that accounts for a significant amount of variance in OCD symptom severity

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew M Lee, MD, PhD

CONTACT

[email protected]

415-502-5472

Tenzin Norbu, BS

CONTACT

[email protected]

415-514-6489

Sponsors and collaborators

Lead sponsor

Andrew Moses Lee, MD, PhD

Other

Registry information

Official study title

Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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