Status:
RECRUITING
Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder
Lead Sponsor:
Rabin Medical Center
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
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), a...
Detailed Description
Obsessive-compulsive disorder (OCD) is characterized by the presence of intrusive obsessions, compulsions, or both. Despite undergoing optimal pharmacological and psychological treatment, around a ten...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05995951
Start Date
October 12 2021
End Date
September 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel