Trial record 1 of 38 for:    obsessive-compulsive disorder AND deep-brain stimulation
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Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2015 by Tang-Du Hospital
Sponsor:
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT02601677
First received: November 8, 2015
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Obsessive Compulsive Disorder
Procedure: Deep brain stimulation
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Global assessment of functioning (GAF) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • The Hamilton Anxiety Scale (HAM-A) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • The Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Event related potentials(ERPs) [ Time Frame: Baseline,3 month,6 month and 12 month ] [ Designated as safety issue: No ]
  • local field potential(LFP) [ Time Frame: in surgery,7 days after surgery ] [ Designated as safety issue: No ]
  • Change in two static positron emission tomography(PET) images study [ Time Frame: Baseline and 6month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02601677

Contacts
Contact: Guo-dong Gao, M.D. +86 29 84777435 gguodong@fmmu.edu.cn
Contact: Xue-lian Wang, M.D. +86 29 84777284 wxlian@fmmu.edu.cn

Sponsors and Collaborators
Tang-Du Hospital
  More Information

Responsible Party: Guodong Gao, Neurosurgery Department, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02601677     History of Changes
Other Study ID Numbers: OCD-DBS 
Study First Received: November 8, 2015
Last Updated: November 9, 2015
Health Authority: China: Ministry of Health

Keywords provided by Tang-Du Hospital:
Obsessive Compulsive Disorder
Deep Brain Stimulation
Nucleus accumbens

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes
Impulsive Behavior
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016