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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01267409
Collaborator
(none)
20
1
24
0.8

Study Details

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,

Condition or Disease Intervention/Treatment Phase
  • Other: STN stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mapping and Manipulating the Emotional Territories of the Subthalamic (STN) Area in Deep Brain Stimulation (DBS) Treated Parkinson Patients
Study Start Date :
Dec 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Outcome Measures

Primary Outcome Measures

  1. Electrophysiological recording and STN mapping [24 m]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hadassah Medical Organization, Jerusalem, Israel Jerusalem Israel

Sponsors and Collaborators

  • Hadassah Medical Organization

Investigators

  • Principal Investigator: Renana Eitan, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Renana Eitan, Dr, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01267409
Other Study ID Numbers:
  • EmotionalPD-HMO-CTIL
First Posted:
Dec 28, 2010
Last Update Posted:
Jan 13, 2012
Last Verified:
Jan 1, 2012

Study Results

No Results Posted as of Jan 13, 2012