Mapping and Stimulating the Limbic Areas of the Subthalamic Nucleus
NCT ID: NCT01962194
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PD and OCD paients for DBS intervention
Parkinson's disease (PD; n=5) and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with STN DBS will be recruited over a period of two years.
Deep Brain Stimulation
In this study we will use implantable Deep Brain Stimulation (DBS) system with local field potential sensing capability. The Device is the Medtronic, Inc DBS Implantable System, "Activa PC+S", which has therapy equivalent to "Activa PC", and has a new sensing programmer.
Interventions
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Deep Brain Stimulation
In this study we will use implantable Deep Brain Stimulation (DBS) system with local field potential sensing capability. The Device is the Medtronic, Inc DBS Implantable System, "Activa PC+S", which has therapy equivalent to "Activa PC", and has a new sensing programmer.
Eligibility Criteria
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Inclusion Criteria
i. advanced idiopathic PD ii. long-term levodopa use that leads to decreased efficacy and increased incidence of adverse effects iii. normal cognitive function or mild-moderate cognitive decline (Addenbrooke's Cognitive Examination (ACE) \> 75 and the Frontal Assessment Battery (FAB) \> 10.
2. Age 40-75 years
3. Male or female
4. Competent and willing to give written informed consent
1. Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID-IV)
2. Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 25
3. Documented highly treatment refractory OCD; the documentation must demonstrate persistence of severe symptoms and impairment for 5 or more years despite both pharmacological and psychological treatments.
4. Either drug free or on a stable drug regimen for at least 6 weeks before study entry
5. General good overall health
6. Age 20-70 years
7. Male or female
8. Competent and willing to give written informed consent.
Exclusion Criteria
2. Significant suicidal risk \[Hamilton Depression scale item 3 (suicide) \>2\]
3. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
4. Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) \< 75 and the Frontal Assessment Battery (FAB) \< 10.
5. Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
6. Any clinically significant abnormality on preoperative MRI
7. Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
8. Pregnant and/or woman of childbearing age not using effective forms of birth control
1. A diagnosis of severe major depression disorder (MDD) with psychotic features
2. Significant suicidal risk \[Hamilton Depression scale item 3 (suicide) \>2\].
3. Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
4. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
5. Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) \< 75 and the Frontal Assessment Battery (FAB) \< 10.
6. Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
7. Any another current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder
8. Any clinically significant abnormality on preoperative MRI
9. Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
10. Pregnant and/or woman of childbearing age not using effective forms of birth control
20 Years
75 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Principal Investigators
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Renana Eitan, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Center
Jerusalem, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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Renana Eitan, MD
Role: primary
Other Identifiers
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RE403-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id