Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Improving Gait Training in Stroke (NCT NCT01807637)
NCT ID: NCT01807637
Last Updated: 2018-12-11
Results Overview
Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35. 2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany). LED markers are placed on the participant's lower extremity. Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments. Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
Results posted on
2018-12-11
Participant Flow
Subjects were recruited via study advertisements and referrals from physical therapy clinics
Participant milestones
| Measure |
Transcranial Direct Current Stim
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Sham tDCS
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
|---|---|---|
|
Baseline
STARTED
|
4
|
2
|
|
Baseline
COMPLETED
|
4
|
2
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
One Week
STARTED
|
4
|
2
|
|
One Week
COMPLETED
|
4
|
2
|
|
One Week
NOT COMPLETED
|
0
|
0
|
|
One Month
STARTED
|
4
|
2
|
|
One Month
COMPLETED
|
4
|
2
|
|
One Month
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation for Improving Gait Training in Stroke
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stim
n=4 Participants
tDCS will be applied using a Soterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex.
transcranial direct current stim (tDCS): During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off.
|
Sham tDCS
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
transcranial direct current stim (tDCS): During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
45 years
STANDARD_DEVIATION 26.9 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ankle dorsiflexion angle during the swing phase of gait
|
-9.28 degrees
STANDARD_DEVIATION 3.10 • n=5 Participants
|
-0.19 degrees
STANDARD_DEVIATION 4.39 • n=7 Participants
|
-6.25 degrees
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
Slope of recruitment curve
|
7.24 slope of regression line
STANDARD_DEVIATION 0.71 • n=5 Participants
|
5.19 slope of regression line
STANDARD_DEVIATION .87 • n=7 Participants
|
6.42 slope of regression line
STANDARD_DEVIATION 2.09 • n=5 Participants
|
|
Stroke Impact Scale Score
|
53.0 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
68.67 units on a scale
STANDARD_DEVIATION 2.78 • n=7 Participants
|
58.22 units on a scale
STANDARD_DEVIATION 9.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35. 2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany). LED markers are placed on the participant's lower extremity. Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments. Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.
Outcome measures
| Measure |
Active tDCS: Week 5 - Baseline.
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Active tDCS: Week 8 - Baseline
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Sham tDCS; Week 5 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
Sham tDCS: Week 8 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
|---|---|---|---|---|
|
Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait
|
3.85 degrees
Standard Error 7.60
|
.18 degrees
Standard Error 7.60
|
-4.15 degrees
Standard Error 10.74
|
-1.60 degrees
Standard Error 10.74
|
SECONDARY outcome
Timeframe: Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).A Magstim 200 super rapid2 stimulator with a 110 mm double cone coil will deliver stimulation. First, the TMS motor threshold (MT) will be established and the best location for eliciting MEPs from the contralesional and ipsilesional TA muscle will be tracked on the subject's MRI scan in Brainsight. Recruitment curves will be obtained as follows: 1) delivering ten, single TMS pulses beginning at 70% of MT, 2) increasing TMS intensity by 10% and repeating the process up to 160% of the MT or until a plateau in the recruitment curve is reached, 3) offline data processing will be performed with the Matlab curve fitting toolbox and 4) the threshold, slope, and MEPmax, and the goodness of fit (R2) will be calculated. A change in the slope of the recruitment curve will indicate change in cortical excitability.
Outcome measures
| Measure |
Active tDCS: Week 5 - Baseline.
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Active tDCS: Week 8 - Baseline
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Sham tDCS; Week 5 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
Sham tDCS: Week 8 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
|---|---|---|---|---|
|
Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).
|
.98 Slope of a regression line
Standard Error 1.73
|
.89 Slope of a regression line
Standard Error 1.73
|
-1.32 Slope of a regression line
Standard Error 2.12
|
-1.84 Slope of a regression line
Standard Error 2.12
|
SECONDARY outcome
Timeframe: Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).The Stroke Impact Scale-16 (SIS-16, completed by study team) is a standardized instrument 36-38 that assesses 3 functional domains in stroke patients including ADL / IADL, mobility, and social and occupational engagement. It consists of 64 - 5 point likert scale questions with a total score range of 64(lowest) to 320 (highest).
Outcome measures
| Measure |
Active tDCS: Week 5 - Baseline.
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Active tDCS: Week 8 - Baseline
n=4 Participants
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Sham tDCS; Week 5 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
Sham tDCS: Week 8 - Baseline.
n=2 Participants
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
|---|---|---|---|---|
|
Change From Baseline in Stroke Impact Scale Scores
|
1.75 units on a scale
Standard Error 4.82
|
1.25 units on a scale
Standard Error 4.82
|
6.82 units on a scale
Standard Error .77
|
00. units on a scale
Standard Error 6.80
|
Adverse Events
Transcranial Direct Current Stim
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcranial Direct Current Stim
n=4 participants at risk
tDCS will be applied using a DeluxeSoterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere \[established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment\]. The cathodal electrode will be placed over the contralateral motor cortex. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
|
Sham tDCS
n=2 participants at risk
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
|
|---|---|---|
|
General disorders
headache
|
50.0%
2/4 • Adverse events data were collected over a 2 year period
|
0.00%
0/2 • Adverse events data were collected over a 2 year period
|
|
Musculoskeletal and connective tissue disorders
Rolled ankle
|
25.0%
1/4 • Adverse events data were collected over a 2 year period
|
0.00%
0/2 • Adverse events data were collected over a 2 year period
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/4 • Adverse events data were collected over a 2 year period
|
50.0%
1/2 • Adverse events data were collected over a 2 year period
|
|
Cardiac disorders
CABG surgery
|
0.00%
0/4 • Adverse events data were collected over a 2 year period
|
50.0%
1/2 • Adverse events data were collected over a 2 year period
|
Additional Information
Mark Mennemeier, PhD
University of Arkansas for Medical Sciences
Phone: 15015267773
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place