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rTMS for Motor and Mood Symptoms of Parkinson's Disease (MASTER-PD)

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
University of Florida
University Health Network, Toronto
The Cleveland Clinic
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01080794
First received: March 3, 2010
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: January 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Parkinson's Disease
Depression
Intervention: Device: Repetitive transcranial magnetic stimulation (rTMS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled from 6 clinical centers in the United States and 1 clinical center in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We enrolled 61 subjects into this study with a previous enrollment goal of 85. Interim analysis revealed that 61 subjects provided sufficient power for data analysis, therefore we stopped recruitment.

Reporting Groups
  Description
Double rTMS

High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).

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.

M1 Active rTMS + DLPFC Sham rTMS

High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).

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.

DLPFC Active rTMS + M1 Sham rTMS

High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).

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.

Double Sham rTMS

Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).

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.


Participant Flow:   Overall Study
    Double rTMS   M1 Active rTMS + DLPFC Sham rTMS   DLPFC Active rTMS + M1 Sham rTMS   Double Sham rTMS
STARTED   20   14   12   15 
COMPLETED   15   12   10   13 
NOT COMPLETED   5   2   2   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Double rTMS

High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).

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.

M1 Active rTMS + DLPFC Sham rTMS

High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).

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.

DLPFC Active rTMS + M1 Sham rTMS

High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).

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.

Double Sham rTMS

Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).

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.

Total Total of all reporting groups

Baseline Measures
   Double rTMS   M1 Active rTMS + DLPFC Sham rTMS   DLPFC Active rTMS + M1 Sham rTMS   Double Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   14   12   15   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.2  (8.0)   62.7  (13.0)   67.3  (12.7)   66.2  (12.7)   66.3  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      9  45.0%      5  35.7%      6  50.0%      4  26.7%      24  39.3% 
Male      11  55.0%      9  64.3%      6  50.0%      11  73.3%      37  60.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Motor Subscale of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

2.  Primary:   Hamilton Depression Scale (HAM-D)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

3.  Secondary:   Clinical Anxiety Scale (CAS)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

4.  Secondary:   Apathy Evaluation Scale (AES)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

5.  Secondary:   Parkinson's Disease Questionnaire 39 (PDQ-39)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

6.  Secondary:   Montreal Cognitive Assessment (MoCA)   [ Time Frame: pre-treatment; 0,1,3, and 6 months post-treatment ]

7.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Parts I, II, and IV   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

8.  Secondary:   Beck Depression Inventory (BDI-II)   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

9.  Secondary:   Global Impression Scales   [ Time Frame: Pre-treatment; Post-treatment 0,1,3, and 6 months. ]

10.  Secondary:   The Number All Types of Adverse Events.   [ Time Frame: Baseline through Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study did not reach the enrollment goal of 120 patients reducing the statistical power of the study. Additionally, patients with mild and advanced disease with variable years of drug exposure were enrolled, which may obscure effects in subgroups.


  More Information
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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. Alvaro Pascual-Leone
Organization: Beth Israel Deaconess Medical Center
phone: (617) 667-0203
e-mail: apleone@bidmc.harvard.edu


Publications:
Friedman JH, Fernandez HH. The nonmotor problems of Parkinson's Disease. The Neurologist 6(1): 18-27, 2000.
Sackheim HA. The cognitive effectsd of electroconvulsive therapy. Cognitive Disorders: Pathophysiology and Treatment. Moos WH and Gamzu ER. New York, Marcel Decker: 183-228, 1992.
Stallings LE, Speer AM, et al. Combining SPECT and repetitive transcranial magnetic stimulation (rTMS)-left prefrontal stimulation decreases relative perfusion locally in a dose dependent manner. Neuroimage 5: S521 Abstract, 1997.
Talairach J, Tournoux P. Co-planar Stereotaxic Atlas of the Human Brain. New York, Thieme Medical Publishers, Inc. 1988.
Tormos JM, Catala MD, et al. Effects of repetitive transcranial magnetic stimulation (rTMS) on EEG. Neurology 50: A317-A318 Abstract, 1998.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01080794     History of Changes
Other Study ID Numbers: 2010P000002
Study First Received: March 3, 2010
Results First Received: January 12, 2016
Last Updated: March 2, 2017