Emotional and Cognitive Subthalamic Nucleus in Deep Brain Stimulation Treated Parkinson Patients

This study is currently recruiting participants.
Verified May 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Renana Eitan, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01590056
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

About 300 patients with Parkinson's disease (PD) have been successfully treated by deep brain stimulation (DBS) during the last 10 years in Hadassah. In most of the patients the site of stimulation is the subthalamic nucleus (STN). Recent studies by our group and others have demonstrated that the STN is divided into motor and non-motor areas. The investigators have recently shown that electrophysiological mapping of the STN during the surgery can differentiate motor and non-motor areas of the STN. 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 and cognitive states, there is no data that correlates stimulation parameters with mental and cognitive state. In addition, DBS parameter setting is also believed to influence important verbal functions which are partially related to motor, mental and cognitive states, but no data correlates the verbal function with the DBS stimulation parameters.

The investigators hypothesize that the cognitive areas of the STN have distinct electrophysiological properties similar to our findings with the limbic / mental areas of the STN. The investigators further hypothesize that specific stimulation of these cognitive areas can influence the cognitive state and thus treatment with cognitive-adjusted DBS can improve the cognitive symptoms of PD.

In this project, the investigators intend to map the motor, emotional and cognitive areas of the STN using neuronal (single units) responses to emotional voices and cognitive tasks and to identify the emotional and cognitive spectral signature of the STN single unit activity using spectral analysis and neuronal responses to emotional voices and cognitive tasks. In addition the investigators intend to find the neuronal signature of speech and to find the correlation between motor, mental and limbic electrophysiology to speech. The investigators also intend to investigate the motor, emotional and cognitive processing of PD patients by manipulating the stimulation of the STN. The proposed study will combine neural recording, stimulation and psychological and cognitive tests to shed new light on processing in the basal ganglia, as well as to provide better treatment for PD patients.


Condition Intervention
Parkinson's Disease
Other: Electrophysiological recording

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mapping and Manipulating the Motor, Emotional and Cognitive Territories of the Subthalamic Area in Deep Brain Stimulation Treated Parkinson Patients

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Mapping the motor, emotional and cognitive areas of the STN using neuronal (single units) responses to motor stimuli, emotional voices and cognitive tests during surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PD patients
PD patients that are treated or are candidates for treatment with STN DBS
Other: Electrophysiological recording

During the surgery for bilateral DBS electrode implantation, electrophysiological recording from the STN will be made while patients are:

  1. listening to nonverbal affect bursts corresponding to emotions
  2. applying a simple go-no-go auditory test

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PD patients that are treated or are candidates for treatment with STN DBS will be followed for 12 months (n=20). These patients will represent a consecutive sample of community based PD patients who will be enrolled in a prospective, open label, clinical trial.

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 (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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590056

Contacts
Contact: Renana Eitan, M.D. 972-050-4048165 renanaeitan@gmail.com

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem,, Israel, 91120
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, Head, Neuropsychiatry Clinic, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01590056     History of Changes
Other Study ID Numbers: STN_Cog_HMO-CTIL, 0064-12-HMO
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Mapping limbic areas of the STN
neuronal responses to stimuli during surgery

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 16, 2014