Magnetic Stimulation for Parkinson Disease
Primary Purpose
Parkinson's Disease, Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prefrontal transcranial magnetic brain stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's, Depression, Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of idiopathic Parkinson's Disease and meet DSM-IV criteria for Major Depressive Episode, severe, with or without psychotic features, or for Mood Disorder secondary to PD with major depression-like episode. Have demonstrated an inadequate clinical response to at least one antidepressant medication in adequate dosage for at least six weeks, or an adverse event requiring discontinuation.
Sites / Locations
- Emory University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00029276
First Posted
January 9, 2002
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00029276
Brief Title
Magnetic Stimulation for Parkinson Disease
Official Title
Transcranial Magnetic Stimulation For Treatment Of Depression In Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part of the head. Electric current passes through the coil in brief pulses. Magnetism from the current produces a separate, small electric current inside the brain, which activates brain cells below the coil. This treatment may result in decreased depression and improved Parkinson's disease symptoms.
Detailed Description
The major aim of this study is to carry out a sequential Phase I trial of prefrontal transcranial magnetic brain stimulation (TMS) and electroconvulsive therapy (ECT) in patients with Parkinson's disease (PD) and severe depression. Depression complicates PD in up to 50% of cases, leading to further deterioration of motor performance and quality of life; but antidepressant medication fails or produces intolerable side effects in 25-30% of patients. Case reports and uncontrolled trials suggest that ECT is effective in ameliorating simultaneously the mood and motor symptoms of PD. Only a few small studies of ECT in PD have been prospective or randomized, the assessment protocols have been limited, and the results have been variable. TMS is a new, promising, alternative treatment for refractory depression, which appears to be easier and safer than ECT. Requiring no hospitalization, anesthesia, or recovery time, TMS is now being investigated as an alternative therapy for mood disorders. TMS has not been studied in depressed patients with PD or in other serious central nervous system diseases.
This study extends our past and present research in PD, depression, ECT, and TMS. We will comprehensively evaluate the effects of left prefrontal TMS on mood, motor, and neuropsychological function, together with quality of life indices in depressed PD patients. All patients will initially receive treatment with TMS. Those who fail to benefit will proceed to ECT. Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups. The key issues addressed by these studies include: (1) the potential benefit of TMS on mood and movement in depressed PD patients, and (2) the tightness of the association between mood and motor function after TMS and ECT. Overall, these studies will provide important preliminary data on the relationships among mood, cognitive and motor function in PD, and their influence on quality of life. The results will help in directing future applications of TMS as an alternative therapy for brain disorders, and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients. A positive effect from TMS should be an impetus towards randomized, placebo-controlled trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Depression
Keywords
Parkinson's, Depression, Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Prefrontal transcranial magnetic brain stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of idiopathic Parkinson's Disease and meet DSM-IV criteria for Major Depressive Episode, severe, with or without psychotic features, or for Mood Disorder secondary to PD with major depression-like episode.
Have demonstrated an inadequate clinical response to at least one antidepressant medication in adequate dosage for at least six weeks, or an adverse event requiring discontinuation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Epstein, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Stimulation for Parkinson Disease
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