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Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients

NCT00885222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-06-03

No results posted yet for this study

Summary

The purpose of this study is:

1. To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects.
2. To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD.
3. To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS.
4. To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.

Conditions

Interventions

DEVICE

DBS parameters setting

DBS parameters will be set to increase the DBS affected volume to include both the cognitive and limbic territories in addition to the dorso-lateral motor territories of the STN. This novel approach to parameter selection is directed to achieve improvement in cognitive and limbic as well as motor domains of PD. The patients will therefore be assessed for cognitive, limbic and motor state at multiple time points; there will be a baseline assessment prior to starting treatment (prior to DBS surgery and/or prior to parameters changes); thereafter assessments will follow the stimulation parameter changes; thereafter follow-up assessments at 6 - 12 months. Stimulation parameters will be changed every 2 weeks or earlier if an urgent clinical state emerges. Patients with depression will be monitored for antidepressant effects of stimulation changes. Patients without depression will be monitored for evidence of treatment emergent depression.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Renana Eitan, MD · Hadassah Medical Organization

  • Zvi Israel, MD · Hadassah Medical Organization

  • Hagai Bergman, MD · Hadassah Medical Organization

  • Bernard Lerer, MD · Hadassah Medical Organization

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00885222 on ClinicalTrials.gov