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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Renana Eitan, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01267409
First received: December 21, 2010
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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 Intervention
Parkinson's Disease
Other: STN stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267409

Contacts
Contact: renana eitan, MD renanaeitan@gmail.com

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    : 00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Renana Eitan, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Renana Eitan, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Renana Eitan, Dr, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01267409     History of Changes
Other Study ID Numbers: EmotionalPD-HMO-CTIL
Study First Received: December 21, 2010
Last Updated: January 12, 2012
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014