Trial Outcomes & Findings for 50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease (NCT NCT00977184)
NCT ID: NCT00977184
Last Updated: 2012-12-27
Results Overview
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 rTMS and sham rTMS. 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 and 1 day post intervention.
COMPLETED
PHASE1/PHASE2
26 participants
Baseline, 1 day post rTMS
2012-12-27
Participant Flow
Participant milestones
| Measure |
Real rTMS
Subjects receiving real rTMS
|
Sham rTMS
Subjects receiving sham rTMS.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Real rTMS
n=13 Participants
Subjects receiving real rTMS
|
Sham rTMS
n=13 Participants
Subjects receiving sham rTMS.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Duration of Disease
|
8.6 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
8.96 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Hoehn-Yahr, "on"
|
2.4 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.3 • n=7 Participants
|
2.42 units on a scale
STANDARD_DEVIATION .27 • n=5 Participants
|
|
Hoehn-Yahr "off"
|
2.7 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
|
Total LED
|
861 milligrams
STANDARD_DEVIATION 436 • n=5 Participants
|
949 milligrams
STANDARD_DEVIATION 677 • n=7 Participants
|
905 milligrams
STANDARD_DEVIATION 559.6 • n=5 Participants
|
|
Tremor
Presence of Tremor
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Tremor
Absence of Tremor
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Gait freezing
Presence of Gait Freezing
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Gait freezing
Absence of Gait Freezing
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Fluctuations
Presence of Fluctuations
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Fluctuations
Absence of Fluctuations
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Dyskinesias
Presence of dyskinesias
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Dyskinesias
Absence of dyskinesias
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Falls
Presence of falls
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Falls
Absence of falls
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 day post rTMSPopulation: Intent to treat
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 rTMS and sham rTMS. 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 and 1 day post intervention.
Outcome measures
| Measure |
On Medication Real rTMS
n=13 Participants
Subjects ON medication while receiving REAL rTMS
|
On Medication Sham rTMS
n=13 Participants
Subjects ON medication while receiving SHAM rTMS
|
Off Medication Real rTMS
n=13 Participants
Subjects OFF medication while receiving REAL rTMS
|
Off Medication Sham rTMS
n=13 Participants
Subjects OFF medication while receiving SHAM rTMS
|
|---|---|---|---|---|
|
Gait Speed
Baseline
|
7.54 seconds
Standard Deviation 0.50
|
8.20 seconds
Standard Deviation 0.50
|
8.31 seconds
Standard Deviation 0.73
|
9.32 seconds
Standard Deviation 0.76
|
|
Gait Speed
1 day post rTMS
|
6.89 seconds
Standard Deviation 0.45
|
7.35 seconds
Standard Deviation 0.45
|
7.41 seconds
Standard Deviation 0.64
|
8.45 seconds
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline, 1 day post rTMSBradykinesia 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 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.
Outcome measures
| Measure |
On Medication Real rTMS
n=13 Participants
Subjects ON medication while receiving REAL rTMS
|
On Medication Sham rTMS
n=13 Participants
Subjects ON medication while receiving SHAM rTMS
|
Off Medication Real rTMS
n=13 Participants
Subjects OFF medication while receiving REAL rTMS
|
Off Medication Sham rTMS
n=13 Participants
Subjects OFF medication while receiving SHAM rTMS
|
|---|---|---|---|---|
|
Bradykinesia
Baseline
|
12.86 seconds
Standard Deviation 0.71
|
11.46 seconds
Standard Deviation 0.74
|
14.12 seconds
Standard Deviation 0.86
|
12.90 seconds
Standard Deviation 0.93
|
|
Bradykinesia
1 day post rTMS
|
10.17 seconds
Standard Deviation 0.65
|
9.30 seconds
Standard Deviation 0.68
|
10.48 seconds
Standard Deviation 0.62
|
9.65 seconds
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline, 1 day post rTMSPopulation: Intent to treat
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.
Outcome measures
| Measure |
On Medication Real rTMS
n=13 Participants
Subjects ON medication while receiving REAL rTMS
|
On Medication Sham rTMS
n=13 Participants
Subjects ON medication while receiving SHAM rTMS
|
Off Medication Real rTMS
n=13 Participants
Subjects OFF medication while receiving REAL rTMS
|
Off Medication Sham rTMS
n=13 Participants
Subjects OFF medication while receiving SHAM rTMS
|
|---|---|---|---|---|
|
Total UPDRS Score
Baseline
|
49.31 units on a scale
Standard Deviation 4.1
|
48.92 units on a scale
Standard Deviation 4.3
|
57.77 units on a scale
Standard Deviation 4.2
|
58.75 units on a scale
Standard Deviation 4.2
|
|
Total UPDRS Score
1 day post rTMS
|
45.00 units on a scale
Standard Deviation 4.2
|
47.67 units on a scale
Standard Deviation 4.4
|
53.46 units on a scale
Standard Deviation 4.0
|
57.75 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline, 1 day post rTMSPopulation: Intent to treat.
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). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.
Outcome measures
| Measure |
On Medication Real rTMS
n=13 Participants
Subjects ON medication while receiving REAL rTMS
|
On Medication Sham rTMS
n=13 Participants
Subjects ON medication while receiving SHAM rTMS
|
Off Medication Real rTMS
n=13 Participants
Subjects OFF medication while receiving REAL rTMS
|
Off Medication Sham rTMS
n=13 Participants
Subjects OFF medication while receiving SHAM rTMS
|
|---|---|---|---|---|
|
Motor UPDRS
Baseline
|
32.08 units on a scale
Standard Deviation 2.5
|
30.00 units on a scale
Standard Deviation 2.6
|
38.46 units on a scale
Standard Deviation 2.2
|
37.25 units on a scale
Standard Deviation 2.3
|
|
Motor UPDRS
1 day post rTMS
|
29.85 units on a scale
Standard Deviation 2.7
|
29.58 units on a scale
Standard Deviation 2.8
|
36.46 units on a scale
Standard Deviation 2.3
|
36.50 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, 1 day post rTMSPopulation: Intent to treat
The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).
Outcome measures
| Measure |
On Medication Real rTMS
n=13 Participants
Subjects ON medication while receiving REAL rTMS
|
On Medication Sham rTMS
n=13 Participants
Subjects ON medication while receiving SHAM rTMS
|
Off Medication Real rTMS
n=13 Participants
Subjects OFF medication while receiving REAL rTMS
|
Off Medication Sham rTMS
n=13 Participants
Subjects OFF medication while receiving SHAM rTMS
|
|---|---|---|---|---|
|
Activities of Daily Living UPDRS
Baseline
|
11.15 units on a scale
Standard Deviation 1.3
|
12.58 units on a scale
Standard Deviation 1.4
|
13.23 units on a scale
Standard Deviation 1.5
|
15.17 units on a scale
Standard Deviation 1.6
|
|
Activities of Daily Living UPDRS
1 day post rTMS
|
9.39 units on a scale
Standard Deviation 1.4
|
11.33 units on a scale
Standard Deviation 1.5
|
11.23 units on a scale
Standard Deviation 1.6
|
14.50 units on a scale
Standard Deviation 1.7
|
Adverse Events
On Medication Real rTMS
Off Medictation Real rTMS
On Medication Sham rTMS
Off Medication Sham rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David H. Benninger, MD
Department of Neurology, Centre Hospitalier Universitaire Vaudois
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place