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
Information provided by (Responsible Party):
Renana Eitan, Hadassah Medical Organization
First received: December 21, 2010
Last updated: January 12, 2012
Last verified: January 2012
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,
Other: STN stimulation
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Mapping and Manipulating the Emotional Territories of the Subthalamic (STN) Area in Deep Brain Stimulation (DBS) Treated Parkinson Patients
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||40 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 (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.
- Age 40-75 years
- Male or female.
- Competent and willing to give written informed consent
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267409
|Hadassah Medical Organization, Jerusalem, Israel
|Jerusalem, Israel |
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com |
|Contact: Hadas Lemberg, PhD : 00 972 2 6777572 firstname.lastname@example.org |
|Principal Investigator: Renana Eitan, MD |
Hadassah Medical Organization
||Renana Eitan, MD
||Hadassah Medical Organization
||Renana Eitan, Dr, Hadassah Medical Organization
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2010
||January 12, 2012
||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:
ClinicalTrials.gov processed this record on May 04, 2016
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases