Health TrialsbyHealthPanel

Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorNader Pouratian

About this trial

The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are:

* Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms. * Map the amSTN using neuronal responses \[single unit and local field potentials (LFP) recordings\] at rest and under high frequency stimulation during surgery. * Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.

Researchers will compare active deep brain stimulation to a placebo (sham stimulation) to see if DBS works to treat refractory OCD.

Participants will:

* Undergo surgery for the implantation of a deep brain stimulation device * Follow-up visits every three weeks with study staff * 6 month follow-up for the next 2-3 years after first year of study participation is complete

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria

Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27

Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.

Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.

Disqualifiers

Diagnosis of severe major depression disorder (MDD) with psychotic features.

Significant suicidal risk [Hamilton Depression scale item 3 (suicide)>2].

Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.

History of substance or alcohol dependence or abuse in the preceding 12 months.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]

    Device

    Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Sham Stimulation=DBS OFF

  • Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

    Device

    Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Therapeutic Stimulation= DBS ON

Treatment groups

10 Participants
are divided into 3 treatment groups
Group A: Sham Control stimulation, then Therapeutic stimulationExperimental treatment 2 interventions
Group B: Therapeutic stimulation, then Sham Control stimulationExperimental treatment 2 interventions
Group C: Therapeutic stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS

Assessment of the efficacy of amSTN stimulation on OCD symptoms. This will be assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Possible scores range from 0-5 where lower scores indicate better outcome.

Time frame
36 months
2

Incidence of Adverse events

Safety will be assessed with cumulative serious adverse event rate that will be Frequency at which AEs occur that are directly related to the study device.

Time frame
36 months

Secondary outcomes

1

Effect of DBS on Mood and Quality of Life as measured by HAM-A survey

Hamilton Scale for Anxiety. A rating scale developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and semantic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score ranger of 0-56, where 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Time frame
36 months
2

Effect of DBS on Mood and Quality of Life as measured by HAM-D21 survey

Hamilton Depression Rating Scale (HAM-D). A 21-item version of the HAM-D that includes 4 items intended to subtype the depression. The HAM-D is originally a 17 item questionnaire pertaining to symptoms of depression experienced over the past week. The patients score is determined using the first 17 questions. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. Scoring on each question varies.

Time frame
36 months
3

Effect of DBS on Mood and Quality of Life as measured by BPRS survey

Brief Psychiatric Rating Scale (BPRS). An assessment that assesses the level of the following symptoms; somatic concern, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement, disorientation. Items are scored on a 1(not present) to 7 (extremely severe) scale. It is based on the clinicians interview with the patients and observations of the patient behavior over the previous 2-3 days.

Time frame
36 months
4

Effect of DBS on Mood and Quality of Life as measured by CGI-S survey

Clinical Global Inventory- Severity scale is used to measure this outcome (CGI-S). This is a 3-item observer-rated scale that measures illness severity (CGI-S). The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through 7 (amongst the most severely ill patients).

Time frame
36 months

Other outcomes

Sponsors and contacts

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

Nader Pouratian

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

Source ClinicalTrials.gov
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