Deep-brain Stimulation in Obsessive-compulsive Disorder: Randomized, Double-blinded Clinical Trial

NCT03217123 | Completed

• 1 other identifier: 10/131
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, randomized, double-blinded study was conducted in 7 OCD patients during which 4 electrode contacts along a striatal axis were stimulated bilaterally. DBS electrode implantation followed a trajectory placing contact zero in nucleus accumbens (a common target for OCD treatment) with more proximal contacts placed in striatal segments defined using projections from prefrontal cortex subdivisions (ventromedial, orbitofrontal, dorsolateral) and anterior cingulate cortex.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD, DBS, fMRI, Y-BOCS, tractography

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale

  OCD symptoms scale

  2 years

Secondary Outcomes (1)

• Emotion

  2 years

Other Outcomes (1)

• Neuropsychology

  2 years

Study Arms (1)

Deep Brain stimulation

EXPERIMENTAL

After the surgery, a random sequence of contact activations (0 \[Nacc\],1,2 and 3), including sham (-), was generated for each patient. Each contact was activated using 130 Hz, 60 ms, and 4.5 V for three months (the sham activation was 0 V) following the patient's individual sequence, separated by one month of washout with the generator turned off

Device: Deep Brain stimulation

Interventions

Deep Brain stimulation DEVICE

Electrical stimulation at subcortical level

Also known as: Medtronic lead

Deep Brain stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from treatment-refractory obsessive compulsive disorder
• Scored 30 or higher in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
• Considered as candidates to DBS for OCD by two independent psychiatrists.
• An independent psychiatric surgery committee composed of one neurosurgeon, one psychiatrist and one legal medicine expert agreed surgery indication was appropriate
• Provide written informed consent.

You may not qualify if:

• Any concomitant neurological or psychiatric condition
• Any surgical contraindication

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Related Publications (4)

• Nuttin B, Cosyns P, Demeulemeester H, Gybels J, Meyerson B. Electrical stimulation in anterior limbs of internal capsules in patients with obsessive-compulsive disorder. Lancet. 1999 Oct 30;354(9189):1526. doi: 10.1016/S0140-6736(99)02376-4.

  PMID: 10551504 BACKGROUND

• Mataix-Cols D, Wooderson S, Lawrence N, Brammer MJ, Speckens A, Phillips ML. Distinct neural correlates of washing, checking, and hoarding symptom dimensions in obsessive-compulsive disorder. Arch Gen Psychiatry. 2004 Jun;61(6):564-76. doi: 10.1001/archpsyc.61.6.564.

  PMID: 15184236 BACKGROUND

• 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. Epub 2010 Feb 8.

  PMID: 20116047 BACKGROUND

• 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.

  PMID: 20921122 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Juan A Barcia, MD PhD

  Hospital San Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients were blind to the study phase (contact and parameters of stimulation).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurosurgery Department

Model Details: The study meets a double-blind, longitudinal design. Stimulation contact was set following a random series known only by the neurosurgeon, with patient, psychiatry and neuropsychology teams blind. Psychiatric assessment was conducted each month, and neuropsychological testing was performed after each activation and washout period

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 13, 2017
• Study Start: January 1, 2011
• Primary Completion: December 31, 2014
• Study Completion: June 30, 2015
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2017-2018