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Sponsor study identifier
interventional
10
1 country
1
Study Start
October 12, 2021
Actual (reported)Primary Completion
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2021
Actual (reported)April 17, 2023
Actual (reported)August 16, 2023
Actual (reported)September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
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.
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.
Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN)
Deep brain stimulation (DBS) surgery - Sham stimulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rabin Medical Center
Petah Tikva, Israel
Idit Idit
Rabin Medical Center
First Submitted
April 17, 2023
First Posted
August 16, 2023
Study Start
October 12, 2021
Actual (reported)Primary Completion
September 1, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 4, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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