Emotional and Cognitive Subthalamic Nucleus in Deep Brain Stimulation Treated Parkinson Patients
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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 |
- 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:
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Renana Eitan, M.D. | 972-050-4048165 | renanaeitan@gmail.com |
| 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 | |
| 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 May 16, 2013