Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

NCT04806516 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: 491551UH3NS10054949340
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD affects 2-3% of the US population, and is responsible for substantial functional impairment and increased risk of early death. The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure and response prevention and certain medications. About 30-40% of patients fail to respond and few experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT and the risk of relapse after therapies remains large. For the most severe cases, neurosurgery (surgery in the brain), has long been the option of last resort. In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep brain stimulation (DBS) remains investigational for OCD patients and is not considered standard therapy. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for OCD treatment. This current research protocol will focus on the completion of Phase II which will implant the RC+S system with ECoG paddles in 5 subjects.

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep Brain Stimulation (DBS); Treatment Resistant OCD; Intractable OCD; Obsessive Compulsive Disorder (OCD); Cognitive Behavior Therapy (CBT); Exposure and Response Prevention (ERP)

Outcome Measures

Primary Outcomes (8)

• Percent of subjects that display biomarkers of OCD-related distress

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  Month 6

• Percent of subjects that display biomarkers of OCD-related distress

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  Month 9

• Percent of subjects that display biomarkers of OCD-related distress

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  Month 12

• Percent of subjects that display biomarkers of OCD-related distress

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  Month 18

• Percent of subjects that display biomarkers of DBS-induced hypomania

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  Month 6

• Percent of subjects that display biomarkers of DBS-induced hypomania

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  Month 9

• Percent of subjects that display biomarkers of DBS-induced hypomania

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  Month 12

• Percent of subjects that display biomarkers of DBS-induced hypomania

  electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  Month 18

Secondary Outcomes (1)

• Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity

  Baseline to 30 days

Study Arms (2)

Summit RC+S DBS Implant for OCD

EXPERIMENTAL

All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles

Device: Summit RC+S System with ECoG Paddles

One Month Blinded Discontinuation Period

EXPERIMENTAL

The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline

Other: One Month Blinded Discontinuation Period:

Interventions

Summit RC+S System with ECoG Paddles DEVICE

Summit RC+S System with ECoG Paddles consists of: * Olympus RC+S implantable pulse generator (IPG), Model B35300R: 2 per subject x 5 subjects = 10 units * Extension Leads, Model 37087: 2 per subject X 5 subjects = 10 units * DBS Leads, Model 3387: 2 per subject X 5 subjects = 10 units * Patient Therapy Manager (PTM), Model 4NR009: 1 per subject x 5 subjects = 5 units * Recharge Therapy Manager (RTM), Model 97755: 1 per subject x 5 subjects = 5 units * Clinician Telemetry Module (CTM), Model 4NR011: 1 per subject x 5 subjects = 5 units * Research Lab Programmer (RLP), Model 4NR010: 1 unit * Research Software Development Kit (RDK), Model 4NR013: 2 units * Subdural Quadripolar Paddle Lead, Model 09130: 2 per subject x 5 subjects = 10 units

Also known as: Deep Brain Stimulation System, DBS, Summit RC+S

Summit RC+S DBS Implant for OCD

One Month Blinded Discontinuation Period: OTHER

The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.

One Month Blinded Discontinuation Period

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study specific procedures being performed
• Male or female between ages 21 and 70;
• At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
• A primary diagnosis of OCD with Y-BOCS minimum score of 28;
• Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
• Failed or could not tolerate an adequate trial of clomipramine;
• Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
• 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

You may not qualify if:

• Inability or refusal to give informed consent.
• Lifetime diagnosis of psychotic disorders such as schizophrenia;
• Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
• Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
• Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
• Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
• Need for Diathermy
• Contraindications to MRI
• Contraindications to MEG
• Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Pittsburgh: collaborator
• Brown University: collaborator
• Carnegie Mellon University: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medtronic: collaborator

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Wayne Goodman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D. C. and Irene Ellwood Professor and Chair

Model Details: At the end of month 8 after DBS implant, all subjects will enter a one-month delayed onset withdrawal period in which the subject and Independent Evaluators are blinded to timing of discontinuation. See description below.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 18, 2025

Record last verified: 2025-08

Locations

US (3)