Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder

NCT05995951 | Recruiting

• 1 other identifier: 1005-20-RMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will include two parts. The first part will include two patients in a non-blinded, non-randomized, open trial. They will undergo Deep Bran Stimulation (DBS) for OCD (targeting the amSTN), as clinically accepted and approved in Israel (by the MOH) and in other countries in Europe and the US. The second part will include eight patients. This part will be an interventional, randomized, double-blinded clinical trial (patient and psychiatrist; the neurosurgeon will activate stimulation during the randomization period and will not be blinded). All subjects will undergo standard pre-operative psychiatric and neurosurgical assessment. Around 4-6 weeks later subjects will undergo implantation of Medtronic implantable DBS system (bilateral brain leads model 3389, lead extenders and PERCEPT pulse generator). Intraoperative recordings will include single unit and local field potentials (LFP) for target identification and validation, as accepted for clinical use. In the second part of the study, blinded randomization for treatment or sham-control arms (1:1 ratio) will be held two weeks post-operation. Treatment and sham-control arms will continue for four months. At the end of four months treatment, the groups will be crossed-over for another four months. Thus, the sham-control group will start treatment (using pre-defined stimulation parameters) and the treatment group will start sham stimulation. Four months later (six and a half months from surgery), randomization will be over, and both arms will get open-label active treatment. Psychiatric assessments post-operation will take place after two weeks, one month, and then once every six weeks, in the first year for all study patients. Chronic recordings will take place using the clinically used and approved PERCEPT DBS pulse generator during the first year after surgery.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (8)

• Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)

  Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.

  baseline (before stimulation initiation)

• Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)

  Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.

  four months post-implantation

• Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)

  Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.

  eight months post-implantation

• Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)

  Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms. This will be assessed by the YBOCS. More than a 35% reduction on the YBOCS will be considered clinically significant. YBOCS score (0-40) - lower scores mean a better outcome.

  12 months post-implantation

• Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures

  Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.

  baseline (before stimulation initiation)

• Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures

  Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.

  four months post-implantation

• Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures

  Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.

  eight months post-implantation

• Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures

  Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures. This will be measured by correlating various measures of discharge (rate, amplitude, coherence, phase, burstiness, and cross-frequency coupling) and task-related activity (magnitude of modulation, directionality, and amplitude sensitivity) with the severity of cognitive and mood impairments of patients undergoing surgery.

  12 months post-implantation

Secondary Outcomes (8)

• The effects of DBS on mood

  baseline (before stimulation initiation)

• The effects of DBS on mood

  four months post-implantation

• The effects of DBS on mood

  eight months post-implantation

• The effects of DBS on mood

  12 months post-implantation

• The effects of DBS on quality of life

  baseline (before stimulation initiation)

Study Arms (2)

Deep Bran Stimulation (DBS) - Treatment group

OTHER

Treatment group will undergo Deep Bran Stimulation (DBS) for OCD (targeting the amSTN) for four months. At the end of four months treatment, the groups will be crossed-over for another four months. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.

Device: Deep Bran Stimulation (DBS)

Sham-control

OTHER

sham stimulation for four months. At the end of four months treatment, the groups will be crossed-over for another fourmonths. Thus, the sham group will start active stimulation and the treatment group will start sham treatment for four months.

Device: Sham-stimulation

Interventions

Deep Bran Stimulation (DBS) DEVICE

Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN)

Deep Bran Stimulation (DBS) - Treatment group

Sham-stimulation DEVICE

Deep brain stimulation (DBS) surgery - Sham stimulation

Sham-control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of obsessive-compulsive disorder according to DSM 5 criteria, diagnosed by three independent psychiatrists not routinely involved with the patients' treatment.
• Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 25.
• Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
• Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.
• Having failed to improve despite adequate psychotherapy.
• Meet established criteria for implantation of a deep brain stimulation system.
• Patients between ages 18 and 75.
• Ability to understand and sign written informed consent by the patient.

You may not qualify if:

• Diagnosis of severe major depression disorder (MDD) with psychotic features.
• Significant suicidal risk \[Hamilton Depression scale item 3 (suicide) \>2\].
• Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post-Traumatic Stress Disorder (PTSD), Eating Disorder, Autistics Spectrum Disorder.
• History of substance or alcohol dependence or abuse in the preceding 12 months.
• Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \<26) and Montreal Cognitive Assessment (MoCA; \<24).
• Any other current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
• Any clinically significant abnormality on preoperative MRI.
• Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other significant medical risk factors for surgery.
• Pregnancy.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Idit Idit

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit TamirIdit

CONTACT

+972 3 9376406; iditta1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: August 16, 2023
• Study Start: October 12, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

IL (1)