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Mapping and Manipulating the Emotional Territories of the Basal Ganglia in PD Patients

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
STN stimulation
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Mapping the emotional territories of the STN, Identifying the emotional spectral signature of the STN single unit activity, Manipulating emotional processing of PD patients by high and low frequency stimulation, Affecting long-term emotional states of the PD patients

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinically definite PD treated / candidates for treatment with DBS (patients with advanced idiopathic PD who are deemed appropriate for DBS surgery).
  2. Patients will be included in the study irrespective of whether a diagnosis of major depression (MDD) (mild to moderate but not severe MDD) is fulfilled at baseline. Patients without depression will be monitored in the study for evidence of treatment emergent depression. Patients with depression will be monitored for antidepressant effects of stimulation change.
  3. Age 40-75 years
  4. Male or female.
  5. Competent and willing to give written informed consent

Exclusion Criteria:

  1. Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2].
  2. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
  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) and the Frontal Assessment Battery (FAB).

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, IsraelRecruiting

Outcomes

Primary Outcome Measures

Electrophysiological recording and STN mapping
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2010
Last Updated
January 12, 2012
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01267409
Brief Title
Mapping and Manipulating the Emotional Territories of the Basal Ganglia in PD Patients
Official Title
Mapping and Manipulating the Emotional Territories of the Subthalamic (STN) Area in Deep Brain Stimulation (DBS) Treated Parkinson Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Mapping the emotional territories of the STN, Identifying the emotional spectral signature of the STN single unit activity, Manipulating emotional processing of PD patients by high and low frequency stimulation, Affecting long-term emotional states of the PD patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
STN stimulation
Intervention Description
Manipulating emotional processing of PD patients by high and low frequency stimulation of their subthalamic area (through the 4 DBS contacts) after the surgery
Primary Outcome Measure Information:
Title
Electrophysiological recording and STN mapping
Description
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.
Time Frame
24 m

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically definite PD treated / candidates for treatment with DBS (patients with advanced idiopathic PD who are deemed appropriate for DBS surgery). Patients will be included in the study irrespective of whether a diagnosis of major depression (MDD) (mild to moderate but not severe MDD) is fulfilled at baseline. Patients without depression will be monitored in the study for evidence of treatment emergent depression. Patients with depression will be monitored for antidepressant effects of stimulation change. Age 40-75 years Male or female. Competent and willing to give written informed consent Exclusion Criteria: Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2]. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) and the Frontal Assessment Battery (FAB).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
renana eitan, MD
Email
renanaeitan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renana Eitan, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
: 00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Renana Eitan, MD

12. IPD Sharing Statement

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Mapping and Manipulating the Emotional Territories of the Basal Ganglia in PD Patients

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