Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) and Motor Training for Traumatic Brain Injury (TBI) Survivors (NCT NCT01749735)
NCT ID: NCT01749735
Last Updated: 2017-05-04
Results Overview
The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post
Results posted on
2017-05-04
Participant Flow
Recruitment target (30) was not reached for this study. Inclusion/exclusion criteria were very restrictive hence making it difficult to recruit subjects.
Participant milestones
| Measure |
Armeo Training With Continuous tDCS
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Armeo Training With Continuous tDCS
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Transcranial Direct Current Stimulation (tDCS) and Motor Training for Traumatic Brain Injury (TBI) Survivors
Baseline characteristics by cohort
| Measure |
Armeo Training With Continuous tDCS
n=2 Participants
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 8 • n=93 Participants
|
—
|
52.5 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
—
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks postThe Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.
Outcome measures
| Measure |
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Continuous tDCS
n=2 Participants
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
|---|---|---|
|
Change in Jebsen-Taylor Hand Function Test Score From Baseline
Day 5
|
—
|
-71.9 seconds
Standard Deviation 67.9
|
|
Change in Jebsen-Taylor Hand Function Test Score From Baseline
Day 10
|
—
|
-79.0 seconds
Standard Deviation 66.6
|
|
Change in Jebsen-Taylor Hand Function Test Score From Baseline
1 week post
|
—
|
-20.1 seconds
Standard Deviation 151.2
|
|
Change in Jebsen-Taylor Hand Function Test Score From Baseline
2 weeks post
|
—
|
-17.4 seconds
Standard Deviation NA
No follow up in one subject
|
|
Change in Jebsen-Taylor Hand Function Test Score From Baseline
4 weeks post
|
—
|
-26.9 seconds
Standard Deviation NA
No follow up in one subject
|
PRIMARY outcome
Timeframe: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks postThe Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the "number of blocks". Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec.
Outcome measures
| Measure |
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Continuous tDCS
n=2 Participants
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
|---|---|---|
|
Change in Box and Block Test Score From Baseline
Day 5
|
—
|
2.5 number of blocks
Standard Deviation 3.5
|
|
Change in Box and Block Test Score From Baseline
Day 10
|
—
|
3.5 number of blocks
Standard Deviation 3.5
|
|
Change in Box and Block Test Score From Baseline
1 week post
|
—
|
3 number of blocks
Standard Deviation 4.2
|
|
Change in Box and Block Test Score From Baseline
2 weeks post
|
—
|
1 number of blocks
Standard Deviation 0
|
|
Change in Box and Block Test Score From Baseline
4 weeks post
|
—
|
6 number of blocks
Standard Deviation 0
|
Adverse Events
Armeo Training With Continuous tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Armeo Training With Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Armeo Training With Continuous tDCS
n=2 participants at risk
Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
Armeo Training With Sham tDCS
Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality.
|
|---|---|---|
|
General disorders
Arm Pain
|
50.0%
1/2 • No adverse events were observed
|
—
0/0 • No adverse events were observed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place