Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder

Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder

Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.

Study Overview

• Status: Unknown
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Procedure: Deep brain stimulation; Drug: Fluoxetine

Detailed Description

Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
2. Duration of illness: min. 5 year;
3. 18 years old <Age <60 years old;
4. Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
5. All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
6. Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
7. Good overall health.

Exclusion Criteria:

1. Present or past history of psychotic symptoms.
2. Severe personality disorders;
3. Any clinically significant neurological disorder or medical illnesses affect ;
4. brain function, other than motor tics or Gilles de la Tourette syndrome;
5. Patient currently treated with anticoagulant or antiplatelet drug;
6. Patient with contraindication for surgery or anesthesia;
7. Inability to undergo awaked operation;
8. Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
9. Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Brain Stimulation; Continuous deep brain stimulation of bilateral nucleus accumbens	Procedure: Deep brain stimulation; Deep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule
Active Comparator: Standard Control; Fluoxetine	Drug: Fluoxetine; Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression (CGI)	6 month
Global assessment of functioning (GAF)	6 month
The Hamilton Anxiety Scale (HAM-A)	6 month
The Hamilton Rating Scale for Depression (HAM-D)	6 month
Sheehan Disability Scale (SDS)	6 month
Event related potentials(ERPs)	Baseline,3 month,6 month and 12 month
local field potential(LFP)	in surgery,7 days after surgery
Change in two static positron emission tomography(PET) images study	Baseline and 6month follow-up

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: November 8, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Obsessive Compulsive Disorder; Nucleus accumbens
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: OCD-DBS