Trial Outcomes & Findings for Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (NCT NCT03100370)
NCT ID: NCT03100370
Last Updated: 2023-05-25
Results Overview
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
baseline
Results posted on
2023-05-25
Participant Flow
Participant milestones
| Measure |
tsDCS-Anodal & Robotic Arm Training (RAT), Then tsDCS-Cathodal & RAT, Then tsDCS-Sham & RAT
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Anodal & Robotic Arm Training (RAT), Then tsDCS-Sham & RAT, Then tsDCS-Cathodal & RAT
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Cathodal & Robotic Arm Training (RAT), Then tsDCS-Anodal & RAT, Then tsDCS-Sham & RAT
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Cathodal & Robotic Arm Training (RAT), Then tsDCS-Sham & RAT, Then tsDCS-Anodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Sham & Robotic Arm Training (RAT), Then tsDCS-Anodal & RAT, Then tsDCS- Cathodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Sham & Robotic Arm Training (RAT), Then tsDCS-Cathodal & RAT, Then tsDCS-Anodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
2
|
1
|
1
|
2
|
2
|
1
|
|
First Intervention (2 Weeks)
COMPLETED
|
2
|
1
|
1
|
1
|
2
|
1
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout (30 Days)
STARTED
|
2
|
0
|
0
|
1
|
2
|
1
|
|
Washout (30 Days)
COMPLETED
|
2
|
0
|
0
|
1
|
2
|
1
|
|
Washout (30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
2
|
1
|
0
|
1
|
2
|
1
|
|
Second Intervention (2 Weeks)
COMPLETED
|
2
|
1
|
0
|
1
|
2
|
1
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (2 Weeks)
STARTED
|
2
|
0
|
0
|
1
|
2
|
1
|
|
Third Intervention (2 Weeks)
COMPLETED
|
2
|
0
|
0
|
1
|
2
|
1
|
|
Third Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
tsDCS-Anodal & Robotic Arm Training (RAT), Then tsDCS-Cathodal & RAT, Then tsDCS-Sham & RAT
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Anodal & Robotic Arm Training (RAT), Then tsDCS-Sham & RAT, Then tsDCS-Cathodal & RAT
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Cathodal & Robotic Arm Training (RAT), Then tsDCS-Anodal & RAT, Then tsDCS-Sham & RAT
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Cathodal & Robotic Arm Training (RAT), Then tsDCS-Sham & RAT, Then tsDCS-Anodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Sham & Robotic Arm Training (RAT), Then tsDCS-Anodal & RAT, Then tsDCS- Cathodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS-Sham & Robotic Arm Training (RAT), Then tsDCS-Cathodal & RAT, Then tsDCS-Anodal & RAT
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functions: 70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
tsDCS-Anodal Stimulation \& robotic-assisted training (RAT) of arm and hand functions: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
tsDCS-Cathodal Stimulation \& robotic-assisted training (RAT) of arm and hand functions: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
tsDCS-Sham Stimulation \& robotic-assisted training (RAT) of arm and hand functions: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: Data were collected for 7 participants in each arm
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Fugl-Meyer Arm (FMA) Motor Score
|
40 score on a scale
Standard Deviation 12.8
|
42 score on a scale
Standard Deviation 13.8
|
42.8 score on a scale
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Fugl-Meyer Arm (FMA) Motor Score
|
40.6 score on a scale
Standard Deviation 13.4
|
43.1 score on a scale
Standard Deviation 13.4
|
44.2 score on a scale
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Fugl-Meyer Arm (FMA) Motor Score
|
42 score on a scale
Standard Deviation 12.3
|
42.4 score on a scale
Standard Deviation 14.7
|
44.4 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were collected for 7 participants in each arm
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Jebsen Taylor Hand Function Test (JTHFT)
|
.17 activities completed per second
Standard Deviation .2
|
.22 activities completed per second
Standard Deviation .2
|
.23 activities completed per second
Standard Deviation .2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were collected for 7 participants in each arm
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Action Research Arm Test (ARAT)
|
34 score on a scale
Standard Deviation 21.5
|
35.2 score on a scale
Standard Deviation 22.8
|
37.2 score on a scale
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were collected for 7 participants in each arm
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Motor Activity Log (MAL)
|
2.07 score on a scale
Standard Deviation 1.4
|
1.99 score on a scale
Standard Deviation 1.3
|
2.15 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were collected for 7 participants in each arm
A pinch gauge will be used to measure maximum pinch force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Pinch Strength
|
10.92 kg of force
Standard Deviation 11.8
|
11.2 kg of force
Standard Deviation 6.5
|
9.4 kg of force
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Change from baseline at 2 weeks and at 1 monthPopulation: Data were not collected for this outcome measure
Robotic movement data will be used to quantitatively measure changes in movement smoothness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data were collected for 7 participants in each arm
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Number of Participants With Adverse Effects Related to tsDCS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Jebsen Taylor Hand Function Test (JTHFT)
|
.18 activities completed per second
Standard Deviation .2
|
.25 activities completed per second
Standard Deviation .2
|
.26 activities completed per second
Standard Deviation .2
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Jebsen Taylor Hand Function Test (JTHFT)
|
.2 activities completed per second
Standard Deviation .2
|
.25 activities completed per second
Standard Deviation .2
|
.22 activities completed per second
Standard Deviation .2
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Action Research Arm Test (ARAT)
|
34.4 score on a scale
Standard Deviation 21.6
|
36.7 score on a scale
Standard Deviation 23.6
|
40.1 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Action Research Arm Test (ARAT)
|
35.1 score on a scale
Standard Deviation 22.5
|
39.5 score on a scale
Standard Deviation 22.7
|
39 score on a scale
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Motor Activity Log (MAL)
|
2.14 score on a scale
Standard Deviation 1.4
|
2.17 score on a scale
Standard Deviation 1.4
|
2.07 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Motor Activity Log (MAL)
|
1.86 score on a scale
Standard Deviation 1.6
|
2.34 score on a scale
Standard Deviation 1.4
|
2.2 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Number of Participants With Adverse Effects Related to tsDCS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Number of Participants With Adverse Effects Related to tsDCS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
A pinch gauge will be used to measure maximum pinch force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Pinch Strength
|
11.8 kg of force
Standard Deviation 3.9
|
12.1 kg of force
Standard Deviation 5.9
|
10.9 kg of force
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
A pinch gauge will be used to measure maximum pinch force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Pinch Strength
|
11.6 kg of force
Standard Deviation 3.6
|
10.4 kg of force
Standard Deviation 4.8
|
9.5 kg of force
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: baselinePopulation: Data were collected for 7 participants in each arm
A grip dynamometer will be used to measure maximum gross grasp force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Grip Strength
|
22.1 kg of force
Standard Deviation 12.5
|
27.3 kg of force
Standard Deviation 17
|
30.1 kg of force
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
A grip dynamometer will be used to measure maximum gross grasp force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Grip Strength
|
21.8 kg of force
Standard Deviation 8.6
|
30.1 kg of force
Standard Deviation 19.1
|
31.8 kg of force
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
A grip dynamometer will be used to measure maximum gross grasp force.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Grip Strength
|
22.5 kg of force
Standard Deviation 8.7
|
31.4 kg of force
Standard Deviation 18.7
|
29.2 kg of force
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: baselinePopulation: Data were collected for 7 participants in each arm
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
|
.4 score on a scale
Standard Deviation .4
|
.2 score on a scale
Standard Deviation .2
|
.3 score on a scale
Standard Deviation .3
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data were collected for 7 participants in each arm
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
|
.3 score on a scale
Standard Deviation .2
|
.2 score on a scale
Standard Deviation .3
|
.3 score on a scale
Standard Deviation .2
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were collected for 7 participants in each arm
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Outcome measures
| Measure |
tsDCS- Cathodal Stimulation & RAT
n=7 Participants
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal Stimulation: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
n=7 Participants
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal Stimulation: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
tsDCS- Sham Stimulation & RAT
n=7 Participants
sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham Stimulation: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
|
|---|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
|
.2 score on a scale
Standard Deviation .2
|
.05 score on a scale
Standard Deviation .09
|
.3 score on a scale
Standard Deviation .3
|
SECONDARY outcome
Timeframe: Change from baseline at 2 weeks and at 1 monthPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline at 2 weeks and at 1 monthPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline at 2 weeks and at 1 monthPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
Adverse Events
tsDCS- Anodal Stimulation & Robotic Arm Training (RAT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tsDCS- Cathodal Stimulation & RAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tsDCS- Sham Stimulation & RAT
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