An observational study in Parkinson's Disease, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-02.
Sponsored by Hadassah Medical Organization · Observational
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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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.
Exclusion Criteria:
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
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
This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization