Emotional and Cognitive Subthalamic Nucleus in Deep Brain Stimulation Treated Parkinson Patients
|ClinicalTrials.gov Identifier: NCT01590056|
Recruitment Status : Unknown
Verified May 2012 by Renana Eitan, Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
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 or disease||Intervention/treatment|
|Parkinson's Disease||Other: Electrophysiological recording|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Mapping and Manipulating the Motor, Emotional and Cognitive Territories of the Subthalamic Area in Deep Brain Stimulation Treated Parkinson Patients|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
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:
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590056
|Contact: Renana Eitan, M.D.||firstname.lastname@example.org|
|Hadassah Medical Organization, Jerusalem, Israel||Recruiting|
|Jerusalem,, Israel, 91120|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Renana Eitan, MD|
|Principal Investigator:||Renana Eitan, MD||Hadassah Medical Organization|