rTMS for Motor and Mood Symptoms of Parkinson's Disease
NCT01080794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2017-04-13
Summary
The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor (movement) and mood symptoms due to Parkinson's disease (PD).
Conditions
Interventions
- DEVICE
-
Repetitive transcranial magnetic stimulation (rTMS)
DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold. M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli). Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS.
Sponsors & Collaborators
-
University of California, Los Angeles
collaborator OTHER -
University of Florida
collaborator OTHER -
University Health Network, Toronto
collaborator OTHER -
The Cleveland Clinic
collaborator OTHER -
Michael J. Fox Foundation for Parkinson's Research
collaborator OTHER -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Alvaro Pascual-Leone, M.D., Ph.D. · Beth Israel Deaconess Medical Center
-
Allan Wu, M.D. · University of California, Los Angeles
-
Hubert Fernandez, M.D. · The Cleveland Clinic
-
Robert Chen, BChir, MA, MB, MSc · University Health Network, Toronto
-
Aparna Wagle-Shukla, MD · University of Florida
-
Jau-Shin Lou, MD, PhD · Oregon Health and Science University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- United States
- Canada
Study Locations
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