Development of Adaptive Deep Brain Stimulation for OCD

NCT04281134 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: H449411UH3NS10054949340
• Study Type: interventional
• Target: 3
• 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/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 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 deep brain stimulation 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 Ib which will implant the RC+S system in 2 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 scalp electroencephalography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  [Time Frame: Month 6]

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

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

  [Time Frame: Month 9]

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

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

  Time Frame: Month 12]

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

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

  [Time Frame: Month 18]

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

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

  [Time Frame: Month 6]

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

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

  [Time Frame: Month 9]

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

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

  [Time Frame: Month 12]

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

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

  [Time Frame: Month 18]

Secondary Outcomes (1)

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

  [Time Frame: Baseline to 30 days]

Study Arms (2)

Summit RC+S DBS Implant for OCD

EXPERIMENTAL

all subjects will receive surgical implantation of DBS system

Device: Summit RC+S System

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 DEVICE

Summit RC+S System consists of: (i) One Model B35300R Olympus RC+S neurostimulator; (ii) One Model 4NR009 Patient Therapy Manager; (iii) One Model 4NR011 Clinician Telemetry Module; (iv) Two Model 3387 DBS leads; (v) Two Model 37087-60 DBS extensions; and (vi) One Model 97755 Recharger.

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: 21 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;
• 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 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
• Signed informed consent prior to any study specific procedures being performed
• Male or female between ages 21 and 70

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
• Inability or refusal to give informed consent.
• Lifetime diagnosis of mental illness
• A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
• Any neurological disorders (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
• Pregnant (confirmed by self-report for females of child bearing age)
• Contraindications to MRI

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

Related Publications (1)

• Powell MP, Anso J, Gilron R, Provenza NR, Allawala AB, Sliva DD, Bijanki KR, Oswalt D, Adkinson J, Pouratian N, Sheth SA, Goodman WK, Jones SR, Starr PA, Borton DA. NeuroDAC: an open-source arbitrary biosignal waveform generator. J Neural Eng. 2021 Feb 5;18(1):10.1088/1741-2552/abc7f0. doi: 10.1088/1741-2552/abc7f0.

  PMID: 33152715 DERIVED

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: February 20, 2020
• First Posted: February 24, 2020
• Study Start: October 11, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (3)