Trial Outcomes & Findings for Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease (NCT NCT00082342)
NCT ID: NCT00082342
Last Updated: 2012-12-27
Results Overview
Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.
COMPLETED
PHASE2
25 participants
baseline, 1 day post, 1 month post, 3 months post-tDCS
2012-12-27
Participant Flow
Participant milestones
| Measure |
Real tDCS
Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while "on" medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes.
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Sham tDCS
Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary "tingling" sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while "on" medication.
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|---|---|---|
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Overall Study
STARTED
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13
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12
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Overall Study
COMPLETED
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13
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12
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Real tDCS
n=13 Participants
Subjects received real transcranial direct current stimulation
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Sham tDCS
n=12 Participants
Subjects received sham transcranial direct current stimulation
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Total
n=25 Participants
Total of all reporting groups
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|---|---|---|---|
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Age Continuous
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63.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
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64.2 years
STANDARD_DEVIATION 8.8 • n=7 Participants
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63.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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5 Participants
n=7 Participants
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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7 Participants
n=7 Participants
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16 Participants
n=5 Participants
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Hoehn-Yahr on medication
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2.5 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
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2.4 units on a scale
STANDARD_DEVIATION 0.2 • n=7 Participants
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2.42 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
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Hoehn-Yahr off medication
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2.7 units on scale
STANDARD_DEVIATION 0.3 • n=5 Participants
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2.9 units on scale
STANDARD_DEVIATION 0.4 • n=7 Participants
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2.8 units on scale
STANDARD_DEVIATION 0.4 • n=5 Participants
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PRIMARY outcome
Timeframe: baseline, 1 day post, 1 month post, 3 months post-tDCSPopulation: Intent to treat
Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.
Outcome measures
| Measure |
Real tDCS While on Medication
n=13 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While on Medication
n=12 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Real tDCS While Off Medication
n=13 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While Off Medication
n=12 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Gait Speed Before and After Real and Sham tDCS.
Baseline
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8.7 Seconds
Standard Deviation 2.4 • Interval -1.6 to 1.6
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8.6 Seconds
Standard Deviation 2.6
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9.7 Seconds
Standard Deviation 3.6
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9.5 Seconds
Standard Deviation 4.1
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Gait Speed Before and After Real and Sham tDCS.
One day post tDCS
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7.2 Seconds
Standard Deviation 1.6
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7.6 Seconds
Standard Deviation 1.5
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7.5 Seconds
Standard Deviation 1.5
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9.8 Seconds
Standard Deviation 4.7
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Gait Speed Before and After Real and Sham tDCS.
One month post tDCS
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7.0 Seconds
Standard Deviation 1.2
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8.7 Seconds
Standard Deviation 3.7
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7.6 Seconds
Standard Deviation 1.4
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10.9 Seconds
Standard Deviation 7.3
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Gait Speed Before and After Real and Sham tDCS.
Three month post tDCS
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7.2 Seconds
Standard Deviation 1.5
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8.8 Seconds
Standard Deviation 4.2
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9.0 Seconds
Standard Deviation 4.8
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9.7 Seconds
Standard Deviation 4.6
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SECONDARY outcome
Timeframe: baseline, 1 day post, 1 month post, 3 months post-tDCSThe Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall clinical rating scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score was obtained from subject examination, subject interviews and questionnaires. The UPDRS encompasses measurement of mentation, behavior, mood, activities of daily living and motor skills. The total UPDRS scores ranges from 0 (not affected) to 176 (most severely affected). The UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham, while on medication and off medication.
Outcome measures
| Measure |
Real tDCS While on Medication
n=13 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While on Medication
n=12 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Real tDCS While Off Medication
n=13 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While Off Medication
n=12 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.
Baseline
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42.5 units on a scale
Standard Deviation 10.8
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39.5 units on a scale
Standard Deviation 12.8
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58.4 units on a scale
Standard Deviation 14.7
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53.6 units on a scale
Standard Deviation 14.5
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UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.
1 day post tDCS
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36.9 units on a scale
Standard Deviation 11.1
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32.0 units on a scale
Standard Deviation 11.7
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54.1 units on a scale
Standard Deviation 13.1
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50.4 units on a scale
Standard Deviation 16.2
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UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.
1 month post tDCS
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42.5 units on a scale
Standard Deviation 7.8
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36.1 units on a scale
Standard Deviation 11.0
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56.1 units on a scale
Standard Deviation 13.2
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54.4 units on a scale
Standard Deviation 12.1
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UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.
3 months post tDCS
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43.4 units on a scale
Standard Deviation 9.1
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35.5 units on a scale
Standard Deviation 13.8
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60.1 units on a scale
Standard Deviation 13.6
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52.4 units on a scale
Standard Deviation 17.0
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SECONDARY outcome
Timeframe: baseline, 1 day post, 1 month post, and 3 months post real and sham tDCSThe 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 administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham. Subjects were assessed on medication and off medication.
Outcome measures
| Measure |
Real tDCS While on Medication
n=13 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While on Medication
n=12 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Real tDCS While Off Medication
n=13 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While Off Medication
n=12 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.
Baseline
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22.2 units on a scale
Standard Deviation 8.7
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17.5 units on a scale
Standard Deviation 8.0
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34.0 units on a scale
Standard Deviation 10.0
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26.5 units on a scale
Standard Deviation 8.4
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UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.
1 day post tDCS
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20.4 units on a scale
Standard Deviation 7.7
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15.6 units on a scale
Standard Deviation 7.9
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31.5 units on a scale
Standard Deviation 7.3
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29.0 units on a scale
Standard Deviation 11.7
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UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.
1 month post tDCS
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22.7 units on a scale
Standard Deviation 6.6
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18.6 units on a scale
Standard Deviation 8.1
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31.4 units on a scale
Standard Deviation 9.9
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29.0 units on a scale
Standard Deviation 8.1
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UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.
3 months post tDCS
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23.1 units on a scale
Standard Deviation 7.8
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17.6 units on a scale
Standard Deviation 8.5
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34.0 units on a scale
Standard Deviation 10.3
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27.1 units on a scale
Standard Deviation 10.5
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SECONDARY outcome
Timeframe: baseline, 1 day post, 1 month post, 3 months post tDCSBradykinesia 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 |
Real tDCS While on Medication
n=13 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While on Medication
n=12 Participants
Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Real tDCS While Off Medication
n=13 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
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Sham tDCS While Off Medication
n=12 Participants
Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
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Bradykinesia Measure Before and After Real and Sham tDCS.
Baseline
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12.3 seconds
Standard Deviation 3.5
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12.3 seconds
Standard Deviation 4.0
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14.5 seconds
Standard Deviation 4.5
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14.4 seconds
Standard Deviation 5.3
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Bradykinesia Measure Before and After Real and Sham tDCS.
1 day post tDCS
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8.5 seconds
Standard Deviation 1.8
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10.5 seconds
Standard Deviation 2.3
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8.9 seconds
Standard Deviation 1.8
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11.1 seconds
Standard Deviation 2.6
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Bradykinesia Measure Before and After Real and Sham tDCS.
1 month post tDCS
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9.1 seconds
Standard Deviation 2.0
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10.5 seconds
Standard Deviation 2.3
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9.4 seconds
Standard Deviation 1.9
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11.7 seconds
Standard Deviation 3.8
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Bradykinesia Measure Before and After Real and Sham tDCS.
3 months post tDCS
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9.0 seconds
Standard Deviation 1.8
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10.4 seconds
Standard Deviation 2.5
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9.7 seconds
Standard Deviation 2.0
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11.6 seconds
Standard Deviation 4.0
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Adverse Events
Real tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Real tDCS
n=13 participants at risk
Subjects received real transcranial direct current stimulation
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Sham tDCS
n=12 participants at risk
Subjects received sham transcranial direct current stimulation
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Skin and subcutaneous tissue disorders
Burn
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7.7%
1/13 • Number of events 1
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0.00%
0/12
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place