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Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease (ReStore)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955032
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : February 20, 2012
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
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
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
Hide 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
Arm/Group Title rTMS Treatment Sham Treatment Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 8 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  62.5%
0
   0.0%
10
  41.7%
>=65 years
6
  37.5%
8
 100.0%
14
  58.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 16 participants 8 participants 24 participants
Female
2
  12.5%
3
  37.5%
5
  20.8%
Male
14
  87.5%
5
  62.5%
19
  79.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 8 participants 24 participants
16 8 24
1.Primary Outcome
Title Apathy Evaluation Scale (AES)
Hide Description The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.
Time Frame Pre-Tx; 10 days post tx
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed study procedures were included for analyses.
Arm/Group Title rTMS Pre TX Sham Pre TX rTMS Post TX (Immediate) Sham Post Tx (Immediate)
Hide Arm/Group Description:
Participants in this group were assessed prior to rTMS treatment.
Participants in this group were assessed before sham treatment.
Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Overall Number of Participants Analyzed 16 8 16 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.6  (5.1) 18.8  (3.9) 17.9  (7.0) 16.8  (4.6)
2.Secondary Outcome
Title Lille Apathy Rating Scale (LARS)
Hide Description The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.
Time Frame Pre-Tx; 10 days post-tx
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed study procedures were included for analyses.
Arm/Group Title rTMS Pre tx Sham Pre tx rTMS Post tx Sham Post tx
Hide Arm/Group Description:
Participants in this group received were assessed prior to receiving rTMS treatment.
Participants in this group were assessed prior to receiving Sham treatment.
Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Overall Number of Participants Analyzed 16 8 16 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.6  (9.1) -18.9  (4.5) -20.1  (7.8) -22.1  (5.2)
3.Secondary Outcome
Title Beck Depression Inventory-Second Edition (BDI-II)
Hide Description The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.
Time Frame Pre-Tx; 10 days post-tx
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed study procedures were included for analyses.
Arm/Group Title rTMS Pre tx Sham Pre tx rTMS Post tx Sham Post tx
Hide Arm/Group Description:
Participants in this group were assessed before they received rTMS treatment.
Participants in this group were assessed before they received Sham tx.
Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Overall Number of Participants Analyzed 16 8 16 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.1  (8.4) 17.8  (9.8) 11.8  (8.8) 11.8  (5.4)
4.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide Description The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.
Time Frame Pre-Tx; 10 days post-tx
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed study procedures were included for analyses.
Arm/Group Title rTMS Pre tx Sham Pre tx rTMS Post tx Sham Post tx
Hide Arm/Group Description:
Participants in this group were assessed before they received rTMS treatment.
Participants in this group were assessed before they received sham treatment.
Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Overall Number of Participants Analyzed 16 8 16 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.5  (7.3) 11.9  (6.5) 7.9  (4.8) 8.5  (5.4)
Time Frame Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rTMS Treatment Sham Treatment
Hide Arm/Group Description Participants in this group received rTMS treatment. Participants in this group did not receive rTMS treatment.
All-Cause Mortality
rTMS Treatment Sham Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rTMS Treatment Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/8 (12.50%)    
General disorders     
Falling * 1  0/16 (0.00%)  0 1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, UFL IRB
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rTMS Treatment Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/16 (50.00%)      3/8 (37.50%)    
General disorders     
Headache * 1  2/16 (12.50%)  2 0/8 (0.00%)  0
Fatigue * 1  1/16 (6.25%)  1 1/8 (12.50%)  1
Hallucination * 1  0/16 (0.00%)  0 1/8 (12.50%)  1
Back Pain * 1  1/16 (6.25%)  1 1/8 (12.50%)  1
Worsening PD symptoms * 1  3/16 (18.75%)  3 0/8 (0.00%)  0
Fall * 1  2/16 (12.50%)  2 0/8 (0.00%)  0
Pitting Edema * 1  2/16 (12.50%)  2 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, UFL IRB
Due to recruiting difficulties, only 24 participants completed study participation. Despite this, the investigators still had significant power to examine effects of interest.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hubert Fernandez
Organization: Center for Neurological Restoration Cleveland Clinic
Phone: (216) 445-1108
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00955032     History of Changes
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