rTMS for Motor and Mood Symptoms of Parkinson's Disease

NCT01080794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-04-13

Study results available
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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

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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Entities

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 NCT01080794 on ClinicalTrials.gov