Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease (NCT NCT01100762)
NCT ID: NCT01100762
Last Updated: 2019-10-30
Results Overview
Stride Length was measured in centimeters
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Data collection occurred before and immediately after each training session
Results posted on
2019-10-30
Participant Flow
Study subjects were recruited via phone call or in person from the University of Maryland, Baltimore's Department of Neurology and the Department of Physical Therapy \& Rehabilitation Sciences databases. The recruitment period was from January 2010 through June 2011.
Participant milestones
| Measure |
Single Group
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
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|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Single Group
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionStride Length was measured in centimeters
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
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Stride Length
Pre Intervention
|
102.10 cm
Standard Deviation 24.40
|
112.30 cm
Standard Deviation 27.30
|
109.80 cm
Standard Deviation 25.40
|
|
Stride Length
Post Intervention
|
111.20 cm
Standard Deviation 22.10
|
110.40 cm
Standard Deviation 26.40
|
110.20 cm
Standard Deviation 26.70
|
PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionGait Velocity was measured in meters per second
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
|
Gait Velocity
Pre Intervention
|
0.90 m/s
Standard Deviation 0.23
|
102.10 m/s
Standard Deviation 27.70
|
100.00 m/s
Standard Deviation 24.10
|
|
Gait Velocity
Post Intervention
|
0.985 m/s
Standard Deviation 0.19
|
97.90 m/s
Standard Deviation 25.80
|
98.30 m/s
Standard Deviation 27.00
|
PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionCadence was measured in steps per minute
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
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Cadence
Pre Intervention
|
106.20 steps/min
Standard Deviation 11.60
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109.30 steps/min
Standard Deviation 10.80
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110.00 steps/min
Standard Deviation 11.40
|
|
Cadence
Post Intervention
|
107.00 steps/min
Standard Deviation 9.80
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107.00 steps/min
Standard Deviation 12.70
|
107.20 steps/min
Standard Deviation 10.40
|
PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionSteps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
|
Number of Steps to Regain Balance
Pre Intervention
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2.22 steps
Standard Deviation 1.15
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2.00 steps
Standard Deviation 0.90
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2.28 steps
Standard Deviation 1.31
|
|
Number of Steps to Regain Balance
Post Intervention
|
2.02 steps
Standard Deviation 1.02
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2.10 steps
Standard Deviation 1.01
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1.94 steps
Standard Deviation 1.05
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PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionFirst step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
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First Step Length
Pre Intervention
|
0.340 m
Standard Deviation 0.119
|
0.333 m
Standard Deviation 0.144
|
0.316 m
Standard Deviation 0.136
|
|
First Step Length
Post Intervention
|
0.317 m
Standard Deviation 0.126
|
0.353 m
Standard Deviation 0.151
|
0.326 m
Standard Deviation 0.125
|
PRIMARY outcome
Timeframe: Data collection occurred before and immediately after each training sessionFirst step velocity was measured in meters per second
Outcome measures
| Measure |
Cranial Electric Stimulation (CES)
n=10 Participants
In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
|
Treadmill
n=10 Participants
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
|
CES and Treadmill
n=10 Participants
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
|
|---|---|---|---|
|
First Step Velocity
Pre Intervention
|
0.859 m/sec
Standard Deviation 0.274
|
0.839 m/sec
Standard Deviation 0.369
|
0.767 m/sec
Standard Deviation 0.298
|
|
First Step Velocity
Post Intervention
|
0.807 m/sec
Standard Deviation 0.342
|
0.873 m/sec
Standard Deviation 0.362
|
0.799 m/sec
Standard Deviation 0.275
|
Adverse Events
Single Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place