Trial record 1 of 37 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02601677
Recruitment Status : Not yet recruiting
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Procedure: Deep brain stimulation Drug: Fluoxetine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources

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
Drug: Fluoxetine
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 6 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02601677

Contact: Guo-dong Gao, M.D. +86 29 84777435
Contact: Xue-lian Wang, M.D. +86 29 84777284

Sponsors and Collaborators
Tang-Du Hospital

Responsible Party: Guodong Gao, Neurosurgery Department, Tang-Du Hospital Identifier: NCT02601677     History of Changes
Other Study ID Numbers: OCD-DBS
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes
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