Trial Outcomes & Findings for Transcranial Magnetic Stimulation to Treat Parkinson's Disease (NCT NCT00753519)
NCT ID: NCT00753519
Last Updated: 2012-11-15
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 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.
COMPLETED
PHASE1/PHASE2
28 participants
baseline, 1 day post iTBS
2012-11-15
Participant Flow
Participant milestones
| Measure |
Real iTBS
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
Sham iTBS
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Real iTBS
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
Sham iTBS
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Transcranial Magnetic Stimulation to Treat Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Real iTBS
n=13 Participants
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
n=13 Participants
Sham iTBS
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
63.85 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Duration of disease
|
10.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
6.5 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
8.62 years
STANDARD_DEVIATION 5.87 • n=5 Participants
|
|
Hoehn-Yahr "on"
|
2.6 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.1 • n=7 Participants
|
2.52 units on a scale
STANDARD_DEVIATION 0.17 • n=5 Participants
|
|
Hoehn-Yahr "off"
|
3.0 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.2 • n=7 Participants
|
2.90 units on a scale
STANDARD_DEVIATION 0.32 • n=5 Participants
|
|
Total LED
|
1180.9 milligrams
STANDARD_DEVIATION 662.4 • n=5 Participants
|
732.3 milligrams
STANDARD_DEVIATION 344.8 • n=7 Participants
|
956.6 milligrams
STANDARD_DEVIATION 565.7 • n=5 Participants
|
|
Tremor
Presence of tremor
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Tremor
Absence of tremor
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Gait freezing
Presence of gait freezing
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Gait freezing
Absence of gait freezing
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Fluctuations
Presence of fluctuations
|
11 participants
n=5 Participants
|
4 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Fluctuations
Absence of flucuations
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Dyskinesias
Presence of dyskinesias
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Dyskinesias
Absence of dyskinesias
|
4 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 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 iTBSGait 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.
Outcome measures
| Measure |
On Medication Real iTBS
n=13 Participants
Subjects ON medication while receiving REAL iTBS
|
On Medication Sham iTBS
n=13 Participants
Subjects ON medication while receiving SHAM iTBS
|
Off Medication Real iTBS
n=13 Participants
Subjects OFF medication while receiving REAL iTBS
|
Off Medication Sham iTBS
n=13 Participants
Subjects OFF medication while receiving SHAM iTBS
|
|---|---|---|---|---|
|
Gait Speed
baseline
|
8.35 seconds
Standard Deviation 1.98
|
8.41 seconds
Standard Deviation 1.98
|
25.84 seconds
Standard Deviation 26.1
|
8.80 seconds
Standard Deviation 25.0
|
|
Gait Speed
1 day post
|
7.68 seconds
Standard Deviation 2.02
|
7.96 seconds
Standard Deviation 2.02
|
10.88 seconds
Standard Deviation 3.81
|
8.20 seconds
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: baseline, 1 day post iTBSBradykinesia 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.
Outcome measures
| Measure |
On Medication Real iTBS
n=13 Participants
Subjects ON medication while receiving REAL iTBS
|
On Medication Sham iTBS
n=13 Participants
Subjects ON medication while receiving SHAM iTBS
|
Off Medication Real iTBS
n=13 Participants
Subjects OFF medication while receiving REAL iTBS
|
Off Medication Sham iTBS
n=13 Participants
Subjects OFF medication while receiving SHAM iTBS
|
|---|---|---|---|---|
|
Bradykinesia
baseline
|
13.69 seconds
Standard Deviation 5.33
|
13.25 seconds
Standard Deviation 5.33
|
17.23 seconds
Standard Deviation 8.10
|
14.20 seconds
Standard Deviation 7.78
|
|
Bradykinesia
1 day post
|
10.32 seconds
Standard Deviation 3.48
|
10.88 seconds
Standard Deviation 3.48
|
14.20 seconds
Standard Deviation 7.78
|
10.80 seconds
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: baseline, 1 day post iTBSThe 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 iTBS
n=13 Participants
Subjects ON medication while receiving REAL iTBS
|
On Medication Sham iTBS
n=13 Participants
Subjects ON medication while receiving SHAM iTBS
|
Off Medication Real iTBS
n=13 Participants
Subjects OFF medication while receiving REAL iTBS
|
Off Medication Sham iTBS
n=13 Participants
Subjects OFF medication while receiving SHAM iTBS
|
|---|---|---|---|---|
|
Total UPDRS Score
baseline
|
55.54 units on a scale
Standard Deviation 15.81
|
57.15 units on a scale
Standard Deviation 15.81
|
77.85 units on a scale
Standard Deviation 17.05
|
65.92 units on a scale
Standard Deviation 17.05
|
|
Total UPDRS Score
1 day post
|
51.08 units on a scale
Standard Deviation 16.37
|
47.62 units on a scale
Standard Deviation 16.37
|
70.85 units on a scale
Standard Deviation 16.26
|
70.85 units on a scale
Standard Deviation 16.26
|
SECONDARY outcome
Timeframe: baseline, 1 day post iTBSThe 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).
Outcome measures
| Measure |
On Medication Real iTBS
n=13 Participants
Subjects ON medication while receiving REAL iTBS
|
On Medication Sham iTBS
n=13 Participants
Subjects ON medication while receiving SHAM iTBS
|
Off Medication Real iTBS
n=13 Participants
Subjects OFF medication while receiving REAL iTBS
|
Off Medication Sham iTBS
n=13 Participants
Subjects OFF medication while receiving SHAM iTBS
|
|---|---|---|---|---|
|
Motor UPDRS
baseline
|
32.00 units on a scale
Standard Deviation 12.86
|
37.54 units on a scale
Standard Deviation 12.86
|
49.00 units on a scale
Standard Deviation 12.88
|
45.69 units on a scale
Standard Deviation 12.38
|
|
Motor UPDRS
1 day post
|
29.08 units on a scale
Standard Deviation 12.13
|
32.31 units on a scale
Standard Deviation 12.13
|
43.92 units on a scale
Standard Deviation 12.59
|
41.31 units on a scale
Standard Deviation 12.10
|
Adverse Events
Real iTBS
Sham iTBS
Serious adverse events
| Measure |
Real iTBS
n=13 participants at risk
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
n=13 participants at risk
Sham iTBS
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Real iTBS
n=13 participants at risk
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
n=13 participants at risk
Sham iTBS
|
|---|---|---|
|
Ear and labyrinth disorders
Transient non pulsating tinnitus (L)
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Epileptiform discharges
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
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