Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590445
• Other study ID #: OCD pilot
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 26, 2015
• Last updated: December 4, 2016
• Start date: October 2015
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Ruijin Hospital
• Contact: Chencheng Zhang, MD
• Phone: +8618217122884
• Email: i[@]cczhang.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 65 years.

2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).

3. Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction

4. Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.

5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45 or a score on Sheehan Disability Scale more than 24.

6. Refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. Adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist.

7. OCD medication regimen is stable for at least 4 weeks before enrollment.

Exclusion Criteria:

1. Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).

2. Cluster A or B personality disorder according to DSM-IV-TR criteria, as assessed with the use of the Structured Clinical Interview II.

3. A current severe major depressive episode, determined according to DSM-V criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.

4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain, or contraindications to surgery or anesthesia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder

Intervention

Device:
• deep brain stimulation system

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122. — View Citation

Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. — View Citation

Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group.. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score		Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month	No
Secondary	Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score		Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month	No
Secondary	Adverse Events		Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month	Yes
Secondary	Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score		Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month	No
Secondary	Functional magnetic resonance imaging (fMRI) images		Baseline (preoperative)	No
Secondary	Quality of life: Global assessment of function		Baseline (preoperative), 8 months, 12 months, 24 month	No
Secondary	Disability: WHO disability assessment 2.0		Baseline (preoperative), 8 months, 12 months, 24 month	No
Secondary	Neurobehavior Task (Decision making task, such as Model task, IGT)		Baseline (preoperative), 8 months, 12 months, 24 month	No
Secondary	Neurobehavior Task (Working memory task, such as N-back)		Baseline (preoperative), 8 months, 12 months, 24 month	No
Secondary	Disability: Sheehan Disability Scale		Baseline (preoperative), 8 months, 12 months, 24 month	No
Secondary	Change in Obsessional beliefs questionnaire (OBQ-44) Score		Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month	No
Secondary	Change in Adult Temperament Questionnaire (ATQ-77) Score		Baseline (preoperative), 8 months, 12month, 24 month	No
Secondary	Change in Temperament and Character Inventory Revised (TRI-R) Score		Baseline (preoperative), 8 months, 12month, 24 month	No
Secondary	Cerebral glucose metabolism measured by PET-CT images		Baseline (preoperative), 12 month	No