Health TrialsbyHealthPanel

SEEG-Guided DBS for OCD

ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorCasey H. Halpern, M.D.

About this trial

This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open-label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open-label treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 22 years and ≤ 75 years of age, at the time of screening

Chronic (> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)

Presence of obsessions, compulsions, or both

Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning

Disqualifiers

Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.

In the opinion of the PI and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder

High suicide risk, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) along with clinician assessment; or

A suicide attempt within the past twelve months that led to hospitalization; or

Trial design

Design model

Crossover

Treatments tested in this trial

  • Stereoencephalography (SEEG)

    Device

    For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.

  • Deep Brain Stimulation (DBS)

    Device

    For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: ON-OFF (Stimulation-Sham)Experimental treatment 2 interventions
Group B: OFF-ON (Sham-Stimulation)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Primary Feasibility Endpoint #1 - OCD Relevant Network

Percentage of patients in which an OCD relevant network can be identified

Time frame
14 days
2

Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms

Percentage of patients in which we can identify a stimulation target that acutely improves OCD symptoms during SEEG Stage 1

Time frame
14 days
3

Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2

Percentage of patients willing and able to continue with the DBS Stage 2 after completing the SEEG Stage 1

Time frame
Day 14
4

Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement

Percentage of implanted DBS sites associated with both acute symptomatic improvement during the SEEG Stage 1 and therapeutic benefit during the DBS Stage 2.

Time frame
Approximately 60 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Casey H. Halpern, M.D.

Lead sponsor

University of Pennsylvania

Sponsor institution

Stanford University

Collaborator

University of Pennsylvania

Collaborator

Mayo Clinic

Collaborator

Boston Scientific Corporation

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov
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