Development of Adaptive Deep Brain Stimulation for OCD (Phase 1a)

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Obsessive-Compulsive Disorder

In brief

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. Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation factors. The overall goal is to improve symptom management and reduce stimulation-induced behavioral side effects.

Key facts

Study ID: NCT03457675
Run by: Baylor College of Medicine
People needed: 2
Starts: 2018-07-11
Expected to finish: 2027-06-01
Last updated by the study team: 2026-04-27

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

OCD DBS Subject Inclusion criteria:
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
Non-Implanted Control Subject Inclusion criteria:
Signed informed consent prior to any study specific procedures being performed
Male or female between ages 21 and 70
Implanted ET Subject Inclusion criteria:
Signed informed consent prior to any study specific procedures being performed
Male or female between ages 21 and 70
Diagnosed with Essential Tremor (ET) chronically, EXCLUDING head tremor, and implanted with DBS

You may not qualify if…

OCD DBS Subject Exclusion criteria:
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
Non-Implanted Control Subject Exclusion criteria:
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
Implanted ET Subject Exclusion criteria
ET subjects (with DBS implanted), WITH head tremor, may exacerbate artifact, therefore they will be excluded.
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 other neurological disorder other than ET (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
Contraindications to MRI

Where it is running

University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Brown University — Providence, Rhode Island, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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