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Transcranial Magnetic Stimulation to Treat Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00753519
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Mark Hallett, National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Device: Real iTBS
Device: Sham iTBS
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Real iTBS Sham iTBS
Hide Arm/Group Description iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals. Sham iTBS
Period Title: Overall Study
Started 13 15
Completed 13 13
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Real iTBS Sham iTBS Total
Hide Arm/Group Description iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals. Sham iTBS Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
62.1  (6.9) 65.6  (9.0) 63.85  (8.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
6
  46.2%
2
  15.4%
8
  30.8%
Male
7
  53.8%
11
  84.6%
18
  69.2%
Duration of disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
10.8  (7.1) 6.5  (3.4) 8.62  (5.87)
Hoehn-Yahr "on"   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 13 participants 26 participants
2.6  (0.2) 2.5  (0.1) 2.52  (0.17)
[1]
Measure Description: The Hoehn and Yahr scale is a system used to describe how the symptoms of Parkinson's disease progress. The scale ranges from 1-5 with 1 representing unilateral involvement with minimal or no functional disability and 5 representing confinement to bed or wheelchair unless aided. The Hoehn and Yahr measurement was taken while the subject was on dopaminergic medication.
Hoehn-Yahr "off"   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 13 participants 26 participants
3.0  (0.4) 2.9  (0.2) 2.90  (0.32)
[1]
Measure Description: The Hoehn and Yahr scale is a system used to describe how the symptoms of Parkinson's disease progress. The scale ranges from 1-5 with 1 representing unilateral involvement with minimal or no functional disability and 5 representing confinement to bed or wheelchair unless aided. The Hoehn and Yahr measurement was taken while the subject was off dopaminergic medication for 12 hours or more (overnight).
Total LED   [1] 
Mean (Standard Deviation)
Unit of measure:  Milligrams
Number Analyzed 13 participants 13 participants 26 participants
1180.9  (662.4) 732.3  (344.8) 956.6  (565.7)
[1]
Measure Description: Total levodopa equivalent dose
Tremor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Presence of tremor 10 9 19
Absence of tremor 3 4 7
Gait freezing  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Presence of gait freezing 10 3 13
Absence of gait freezing 3 10 13
Fluctuations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Presence of fluctuations 11 4 15
Absence of flucuations 2 9 11
Dyskinesias   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Presence of dyskinesias 9 2 11
Absence of dyskinesias 4 11 15
[1]
Measure Description: Presence or absence of dyskinesias (diminished voluntary movements and the presence of involuntary movements).
Falls  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Presence of falls 1 0 1
Absence of falls 12 13 25
1.Primary Outcome
Title Gait Speed
Hide Description Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.
Time Frame baseline, 1 day post iTBS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Medication Real iTBS On Medication Sham iTBS Off Medication Real iTBS Off Medication Sham iTBS
Hide Arm/Group Description:
Subjects ON medication while receiving REAL iTBS
Subjects ON medication while receiving SHAM iTBS
Subjects OFF medication while receiving REAL iTBS
Subjects OFF medication while receiving SHAM iTBS
Overall Number of Participants Analyzed 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: seconds
baseline 8.35  (1.98) 8.41  (1.98) 25.84  (26.1) 8.80  (25.0)
1 day post 7.68  (2.02) 7.96  (2.02) 10.88  (3.81) 8.20  (3.66)
2.Secondary Outcome
Title Bradykinesia
Hide Description Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.
Time Frame baseline, 1 day post iTBS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Medication Real iTBS On Medication Sham iTBS Off Medication Real iTBS Off Medication Sham iTBS
Hide Arm/Group Description:
Subjects ON medication while receiving REAL iTBS
Subjects ON medication while receiving SHAM iTBS
Subjects OFF medication while receiving REAL iTBS
Subjects OFF medication while receiving SHAM iTBS
Overall Number of Participants Analyzed 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: seconds
baseline 13.69  (5.33) 13.25  (5.33) 17.23  (8.10) 14.20  (7.78)
1 day post 10.32  (3.48) 10.88  (3.48) 14.20  (7.78) 10.80  (4.03)
3.Secondary Outcome
Title Total UPDRS Score
Hide Description The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.
Time Frame baseline, 1 day post iTBS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Medication Real iTBS On Medication Sham iTBS Off Medication Real iTBS Off Medication Sham iTBS
Hide Arm/Group Description:
Subjects ON medication while receiving REAL iTBS
Subjects ON medication while receiving SHAM iTBS
Subjects OFF medication while receiving REAL iTBS
Subjects OFF medication while receiving SHAM iTBS
Overall Number of Participants Analyzed 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 55.54  (15.81) 57.15  (15.81) 77.85  (17.05) 65.92  (17.05)
1 day post 51.08  (16.37) 47.62  (16.37) 70.85  (16.26) 70.85  (16.26)
4.Secondary Outcome
Title Motor UPDRS
Hide Description The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).
Time Frame baseline, 1 day post iTBS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Medication Real iTBS On Medication Sham iTBS Off Medication Real iTBS Off Medication Sham iTBS
Hide Arm/Group Description:
Subjects ON medication while receiving REAL iTBS
Subjects ON medication while receiving SHAM iTBS
Subjects OFF medication while receiving REAL iTBS
Subjects OFF medication while receiving SHAM iTBS
Overall Number of Participants Analyzed 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 32.00  (12.86) 37.54  (12.86) 49.00  (12.88) 45.69  (12.38)
1 day post 29.08  (12.13) 32.31  (12.13) 43.92  (12.59) 41.31  (12.10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Real iTBS Sham iTBS
Hide Arm/Group Description iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals. Sham iTBS
All-Cause Mortality
Real iTBS Sham iTBS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Real iTBS Sham iTBS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/13 (7.69%)    
Cardiac disorders     
Myocardial infarction [1]  0/13 (0.00%)  0 1/13 (7.69%)  1
[1]
Myocardial infarction considered unrelated to the study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Real iTBS Sham iTBS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/13 (7.69%)    
Ear and labyrinth disorders     
Transient non pulsating tinnitus (L)  1/13 (7.69%)  1 0/13 (0.00%)  0
Nervous system disorders     
Epileptiform discharges  0/13 (0.00%)  0 1/13 (7.69%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David H. Benninger, MD
Organization: Department of Neurology, Centre Hospitalier Universitaire Vaudois
Responsible Party: Mark Hallett, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00753519     History of Changes
Other Study ID Numbers: 080212
08-N-0212
First Submitted: September 13, 2008
First Posted: September 16, 2008
Results First Submitted: August 31, 2012
Results First Posted: November 15, 2012
Last Update Posted: November 15, 2012