Obsessive-Compulsive DisorderNCT05995951
Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder
A study testing Deep Bran Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep Bran Stimulation (DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Oct 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Idit Tamir, MD
Belaynesh Keren Melke, BSc, +972 547576642
About this study
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.
Read the 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 tenth of patients remain with refractory OCD, with a great impact on their everyday function and quality of life.
Deep brain stimulation (DBS) surgery is a safe and effective treatment, used for movement disorders for over 20 years now, and lately was approved worldwide also for intractable epilepsy. In the past decade, many studies of DBS for refractory OCD proved safety and effectiveness with 50% reduction in OCD symptoms of the most refractory patients.
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.
Primary aims:
- Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)/medial forebrain bundle (MFB) stimulation on obsessive/compulsive symptoms
- Map the amSTN using neuronal responses (single unit and LFP recordings) to cognitive-emotion provocation task during surgery
- Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep Bran Stimulation (DBS), Sham-stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Bran Stimulation (DBS)Device
Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN)
Sham-stimulationDevice
Deep brain stimulation (DBS) surgery - Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham-stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post-implantation
Secondary outcomes (8)
The effects of DBS on mood
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: baseline (before stimulation initiation)
The effects of DBS on mood
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: four months post-implantation
The effects of DBS on mood
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: eight months post-implantation
The effects of DBS on mood
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: 12 months post-implantation
The effects of DBS on quality of life
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: baseline (before stimulation initiation)
The effects of DBS on quality of life
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: four months post-implantation
The effects of DBS on quality of life
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: eight months post-implantation
The effects of DBS on quality of life
The effects of DBS on mood and quality of life will be tested using various scales: Hamilton Scale for Anxiety (HAM-A), Hamilton Scale for Depression (HAM-D21), Brief Psychiatric Rating Scale (BPRS), overall state (Clinical Global Inventory [CGI]), and Mini-Mental State Examination (MMSE).
Measured: 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start12 Oct 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit tamit, Rabin Medical Center
- Investigators
- Idit Idit, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995951
- Sponsor's protocol ID
- 1005-20-RMC
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT05995951
- Acronym / sponsor ID
- 1005-20-RMC
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 tenth of patients remain with refractory OCD, with a great impact on their everyday function and quality of life.
Deep brain stimulation (DBS) surgery is a safe and effective treatment, used for movement disorders for over 20 years now, and lately was approved worldwide also for intractable epilepsy. In the past decade, many studies of DBS for refractory OCD proved safety and effectiveness with 50% reduction in OCD symptoms of the most refractory patients.
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.
Primary aims:
- Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)/medial forebrain bundle (MFB) stimulation on obsessive/compulsive symptoms
- Map the amSTN using neuronal responses (single unit and LFP recordings) to cognitive-emotion provocation task during surgery
- Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Bran Stimulation (DBS) - Treatment group | Other | Device: Deep Bran Stimulation (DBS)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-control | Other | Device: Sham-stimulationsham 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Bran Stimulation (DBS)Deep brain stimulation (DBS) surgery targeting the antero-medial Sub-Thalamic Nucleus (amSTN) | Device | Deep Bran Stimulation (DBS) - Treatment group |
| Sham-stimulationDeep brain stimulation (DBS) surgery - Sham stimulation | Device | Sham-control |
Primary outcome
Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
Time frame: baseline (before stimulation initiation)
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.
Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
Time frame: four months post-implantation
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.
Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
Time frame: eight months post-implantation
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.
Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40)
Time frame: 12 months post-implantation
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.
Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
Time frame: baseline (before stimulation initiation)
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.
Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
Time frame: four months post-implantation
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.
Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
Time frame: eight months post-implantation
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.
Assessment of the association between amSTN electrophysiological discharge and cognitive/ emotional measures
Time frame: 12 months post-implantation
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.
8 secondary outcomes
The effects of DBS on mood
Time frame: baseline (before stimulation initiation)
The effects of DBS on mood
Time frame: four months post-implantation
The effects of DBS on mood
Time frame: eight months post-implantation
The effects of DBS on mood
Time frame: 12 months post-implantation
The effects of DBS on quality of life
Time frame: baseline (before stimulation initiation)
The effects of DBS on quality of life
Time frame: four months post-implantation
The effects of DBS on quality of life
Time frame: eight months post-implantation
The effects of DBS on quality of life
Time frame: 12 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Obsessive-Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Idit Idit principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Bran Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idit TamirIdit (+972 3 9376406, iditta1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the efficacy of amSTN/MFB stimulation on OCD symptoms - YBOCS score (0-40) (time frame: baseline (before stimulation initiation)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.