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Robots Paired With tDCS in Stroke Recovery

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ClinicalTrials.gov Identifier: NCT01726673
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: Transcranial Direct Current Stimulation (tDCS)
Device: Placebo sham
Enrollment 54
Recruitment Details  
Pre-assignment Details Subjects were randomized to receive 36 sessions of either active tDCS immediately followed by robotic arm therapy or sham tDCS immediately followed by robotic arm therapy.
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Hide Arm/Group Description

Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).

Placebo sham

Period Title: Overall Study
Started 30 24
Completed 24 21
Not Completed 6 3
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy Total
Hide Arm/Group Description

Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Placebo sham

Total of all reporting groups
Overall Number of Baseline Participants 30 24 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  66.7%
10
  41.7%
30
  55.6%
>=65 years
10
  33.3%
14
  58.3%
24
  44.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
Female
11
  36.7%
9
  37.5%
20
  37.0%
Male
19
  63.3%
15
  62.5%
34
  63.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  10.0%
3
  12.5%
6
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  23.3%
3
  12.5%
10
  18.5%
White
20
  66.7%
13
  54.2%
33
  61.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
5
  20.8%
5
   9.3%
1.Primary Outcome
Title Median Change in Upper Extremity Fugl Meyer Assessment Score
Hide Description The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Time Frame baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Hide Arm/Group Description:

Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).

Placebo sham

Overall Number of Participants Analyzed 24 21
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
Median change from baseline to discharge at 12 wks
4.5
(3 to 8)
6.0
(4 to 8)
Median change from baseline to 6 month follow-up
4
(2 to 7)
6
(4 to 7.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 0.256
Comments The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U test
Comments [Not Specified]
Method of Estimation Estimation Parameter U value
Estimated Value 302
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 0.222
Comments The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U test
Comments [Not Specified]
Method of Estimation Estimation Parameter U value
Estimated Value 222
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Median Change in WOLF Motor Function Test (WMFT)
Hide Description The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.
Time Frame baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Hide Arm/Group Description:

Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).

Placebo sham

Overall Number of Participants Analyzed 24 21
Median (Inter-Quartile Range)
Unit of Measure: seconds
Median change from baseline to discharge at 12 wks
-34
(-235.25 to 0)
-19
(-157 to -1.5)
Median change from baseline to 6 month follow-up
-103
(-245.5 to -5)
-81.5
(-260.5 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 1.0
Comments The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U Test
Comments [Not Specified]
Method of Estimation Estimation Parameter U Value
Estimated Value 251.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 0.592
Comments The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U Test
Comments [Not Specified]
Method of Estimation Estimation Parameter U value
Estimated Value 208.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
Hide Description The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.
Time Frame 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Hide Arm/Group Description:

Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).

Placebo sham

Overall Number of Participants Analyzed 24 21
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
Median change from baseline to discharge at 12 wks
7
(4 to 9.5)
7
(5 to 8)
Median change from baseline to 6 month follow-up
6
(3 to 11.25)
6
(4 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 0.680
Comments The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U test
Comments [Not Specified]
Method of Estimation Estimation Parameter U value
Estimated Value 270.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection tDCS + Robotic Arm Therapy, tDCS Sham + Robotic Arm Therapy
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).
Statistical Test of Hypothesis P-Value 0.837
Comments The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).
Method Mann-Whitney U Test
Comments [Not Specified]
Method of Estimation Estimation Parameter U value
Estimated Value 187.5
Estimation Comments [Not Specified]
Time Frame Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Hide Arm/Group Description

Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).

Placebo sham

All-Cause Mortality
tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
tDCS + Robotic Arm Therapy tDCS Sham + Robotic Arm Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      1/24 (4.17%)    
Musculoskeletal and connective tissue disorders     
back pain flair up * [1]  1/30 (3.33%)  1 0/24 (0.00%)  0
Nervous system disorders     
Myasthenia Gravis * [2]  1/30 (3.33%)  1 0/24 (0.00%)  0
seizure  [3]  0/30 (0.00%)  0 1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subject developed flair up of lower back pain as a result of compromised gait pattern after stroke and consequently had to drop out of the study.
[2]
Subject developed spontaneous eye pstosis at home and was diagnosed with Myasthenia Gravis by treating physician, unrelated to study intervention.
Indicates events were collected by systematic assessment
[3]
Subject from the sham condition experienced a seizure at home greater than 48 hrs after stimulation, and seizure was determined to be unrelated to study intervention by subject's treating neurologist. Subject was withdrawn from study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Johanna Chang, Senior Research Coordinator
Organization: Feinstein Institute for Medical Research at Northwell Health
Phone: (516) 562-3646
Responsible Party: Bruce Volpe, Northwell Health
ClinicalTrials.gov Identifier: NCT01726673     History of Changes
Other Study ID Numbers: 12-102B
First Submitted: October 26, 2012
First Posted: November 15, 2012
Results First Submitted: May 14, 2018
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018