Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease (ReStore)
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ClinicalTrials.gov Identifier: NCT00955032 |
Recruitment Status :
Completed
First Posted : August 7, 2009
Results First Posted : February 20, 2012
Last Update Posted : April 26, 2013
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Sponsor:
University of Florida
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Florida
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Parkinson's Disease |
Interventions |
Device: High-Frequency Repetitive Transcranial Magnetic Stimulation Device: Sham Repetitive Transcranial Magnetic Stimulation |
Enrollment | 24 |
Participant Flow
Recruitment Details | Patients seen clinically for routine clinical care were determined by clinicians if they appeared to qualify for the study. Subjects were asked and consented in a non-coercive manner if they wished to be contacted via telephone about future study participation. Recruitment occurred between March 2007-December 2009. |
Pre-assignment Details |
Arm/Group Title | rTMS Treatment | Sham Treatment |
---|---|---|
Arm/Group Description | Participants in this group received rTMS treatment. | Participants in this group did not receive rTMS treatment. |
Period Title: Overall Study | ||
Started | 16 | 8 |
Completed | 16 | 8 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | rTMS Treatment | Sham Treatment | Total | |
---|---|---|---|---|
Arm/Group Description | Participants in this group received rTMS treatment. | Participants in this group did not receive rTMS treatment. | Total of all reporting groups | |
Overall Number of Baseline Participants | 16 | 8 | 24 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | 8 participants | 24 participants | |
<=18 years |
0 0.0%
|
0 0.0%
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0 0.0%
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Between 18 and 65 years |
10 62.5%
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0 0.0%
|
10 41.7%
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>=65 years |
6 37.5%
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8 100.0%
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14 58.3%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 16 participants | 8 participants | 24 participants | |
63.8 (7.2) | 72.8 (5.7) | 66.8 (7.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | 8 participants | 24 participants | |
Female |
2 12.5%
|
3 37.5%
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5 20.8%
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Male |
14 87.5%
|
5 62.5%
|
19 79.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 16 participants | 8 participants | 24 participants |
16 | 8 | 24 |
Outcome Measures
Adverse Events
Limitations and Caveats
Due to recruiting difficulties, only 24 participants completed study participation. Despite this, the investigators still had significant power to examine effects of interest.
More Information
Results Point of Contact
Name/Title: | Dr. Hubert Fernandez |
Organization: | Center for Neurological Restoration Cleveland Clinic |
Phone: | (216) 445-1108 |
EMail: | fernandez@neurology.ufl.edu |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00955032 |
Other Study ID Numbers: |
0004762006 |
First Submitted: | August 5, 2009 |
First Posted: | August 7, 2009 |
Results First Submitted: | December 5, 2011 |
Results First Posted: | February 20, 2012 |
Last Update Posted: | April 26, 2013 |