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Transcranial Direct Current Stimulation for Improving Gait Training in Stroke

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ClinicalTrials.gov Identifier: NCT01807637
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : November 5, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
University of Central Arkansas
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Cerebral Vascular Accident
Intervention Device: transcranial direct current stim (tDCS)
Enrollment 6
Recruitment Details Subjects were recruited via study advertisements and referrals from physical therapy clinics
Pre-assignment Details  
Arm/Group Title Transcranial Direct Current Stim Sham tDCS
Hide Arm/Group Description 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 stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Period Title: Baseline
Started 4 2
Completed 4 2
Not Completed 0 0
Period Title: One Week
Started 4 2
Completed 4 2
Not Completed 0 0
Period Title: One Month
Started 4 2
Completed 4 2
Not Completed 0 0
Arm/Group Title Transcranial Direct Current Stim Sham tDCS Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 2 participants 6 participants
65.8  (8.9) 45  (26.9) 58.0  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
2
  50.0%
0
   0.0%
2
  33.3%
Male
2
  50.0%
2
 100.0%
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
2
 100.0%
6
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
2
 100.0%
6
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ankle dorsiflexion angle during the swing phase of gait   [1] 
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 4 participants 2 participants 6 participants
-9.28  (3.10) -0.19  (4.39) -6.25  (10.21)
[1]
Measure Description: Normal dorisflexion in mid-swing is 0. More than -5 degrees of plantar flexion is foot drop.
Slope of recruitment curve   [1] 
Mean (Standard Deviation)
Unit of measure:  Slope of regression line
Number Analyzed 4 participants 2 participants 6 participants
7.24  (0.71) 5.19  (.87) 6.42  (2.09)
[1]
Measure Description: The recruitment curve consists of MEPs plotted for increasing intensities of TMS. The slope reflects the rate at which MEP values increase.
Stroke Impact Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 2 participants 6 participants
53.0  (1.97) 68.67  (2.78) 58.22  (9.55)
[1]
Measure Description: Sixteen item scale. Range of scores is 16 to 80. High score means higher functioning.
1.Primary Outcome
Title Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait
Hide Description 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.
Time Frame Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS: Week 5 - Baseline. Active tDCS: Week 8 - Baseline Sham tDCS; Week 5 - Baseline. Sham tDCS: Week 8 - Baseline.
Hide Arm/Group Description:
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).
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 stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Overall Number of Participants Analyzed 4 4 2 2
Mean (Standard Error)
Unit of Measure: degrees
3.85  (7.60) .18  (7.60) -4.15  (10.74) -1.60  (10.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS: Week 5 - Baseline., Active tDCS: Week 8 - Baseline, Sham tDCS; Week 5 - Baseline., Sham tDCS: Week 8 - Baseline.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.37
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).
Hide Description 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.
Time Frame Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS: Week 5 - Baseline. Active tDCS: Week 8 - Baseline Sham tDCS; Week 5 - Baseline. Sham tDCS: Week 8 - Baseline.
Hide Arm/Group Description:
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).
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 stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Overall Number of Participants Analyzed 4 4 2 2
Mean (Standard Error)
Unit of Measure: Slope of a regression line
.98  (1.73) .89  (1.73) -1.32  (2.12) -1.84  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS: Week 5 - Baseline., Active tDCS: Week 8 - Baseline, Sham tDCS; Week 5 - Baseline., Sham tDCS: Week 8 - Baseline.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.05
Parameter Dispersion
Type: Standard Deviation
Value: 1.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Stroke Impact Scale Scores
Hide Description 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).
Time Frame Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS: Week 5 - Baseline. Active tDCS: Week 8 - Baseline Sham tDCS; Week 5 - Baseline. Sham tDCS: Week 8 - Baseline.
Hide Arm/Group Description:
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).
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 stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
Overall Number of Participants Analyzed 4 4 2 2
Mean (Standard Error)
Unit of Measure: units on a scale
1.75  (4.82) 1.25  (4.82) 6.82  (.77) 00.  (6.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS: Week 5 - Baseline., Active tDCS: Week 8 - Baseline, Sham tDCS; Week 5 - Baseline., Sham tDCS: Week 8 - Baseline.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.67
Parameter Dispersion
Type: Standard Deviation
Value: 3.41
Estimation Comments [Not Specified]
Time Frame Adverse events data were collected over a 2 year period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Direct Current Stim Sham tDCS
Hide Arm/Group Description 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 stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
All-Cause Mortality
Transcranial Direct Current Stim Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Direct Current Stim Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Direct Current Stim Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   1/2 (50.00%) 
Cardiac disorders     
CABG surgery *  0/4 (0.00%)  1/2 (50.00%) 
General disorders     
headache *  2/4 (50.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rolled ankle *  1/4 (25.00%)  0/2 (0.00%) 
knee pain *  0/4 (0.00%)  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mark Mennemeier, PhD
Organization: University of Arkansas for Medical Sciences
Phone: 15015267773
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01807637     History of Changes
Other Study ID Numbers: 138159
138159 ( Other Identifier: University of Arkansas for Medical Sciences )
First Submitted: March 6, 2013
First Posted: March 8, 2013
Results First Submitted: October 2, 2018
Results First Posted: November 5, 2018
Last Update Posted: December 11, 2018