Mapping and Manipulating the Emotional Territories of the Basal Ganglia in PD Patients
| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2010 | ||||
| Last Updated Date | January 12, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Electrophysiological recording and STN mapping [ Time Frame: 24 m ] [ Designated as safety issue: No ] Mapping the emotional territories of the STN using neuronal (single units) responses to emotional voices during surgery. Manipulating emotional processing of PD patients by high and low frequency stimulation of their subthalamic area during and after the surgery. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01267409 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mapping and Manipulating the Emotional Territories of the Basal Ganglia in PD Patients | ||||
| Official Title ICMJE | Mapping and Manipulating the Emotional Territories of the Subthalamic (STN) Area in Deep Brain Stimulation (DBS) Treated Parkinson Patients | ||||
| Brief Summary | Depressive symptoms of Parkinson's disease (PD) patients are major predictors of their prognosis and quality of life. Using subthalamic nucleus (STN) deep brain stimulation (DBS) as an antidepressant could be a promising new direction. Existing methods of adjustment of DBS parameters aim at amelioration of the motor signs and therefore with inactivation of the STN motor territory only. Although the DBS parameter setting is believed to influence the mental state, there is no data that correlates stimulation parameters with mental state. The investigators hypothesize that the emotional territories of the STN have distinct electrophysiological properties and that specific stimulation of these emotional territories can influence the mental state and thus treatment with emotionally-adjusted DBS can improve the psychiatric symptoms of PD. In this project, the investigators intend to map the emotional territories of the STN using neuronal (single units) responses to emotional voices and to identify the emotional spectral signature of the STN single unit activity using spectral analysis and neuronal responses to emotional voices. The investigators also intend to investigate the emotional processing of PD patients by manipulating the stimulation of the subthalamic area. The proposed study will combine neural recording, stimulation and psychological tests to shed new light on emotional processing in the basal ganglia, as well as to provide better treatment for PD emotional disorders, |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Other: STN stimulation
Manipulating emotional processing of PD patients by high and low frequency stimulation of their subthalamic area (through the 4 DBS contacts) after the surgery |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01267409 | ||||
| Other Study ID Numbers ICMJE | EmotionalPD-HMO-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Renana Eitan, Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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