Traumatic Brain Injury
Conditions
Brief summary
The aim of this study is to compare the effect of transcranial direct current stimulation and functional upper extremity task training to functional upper extremity task training alone. The functional upper extremity task training uses the Armeo Spring robotic arm to support the limb while playing functional task games on a computer. Specific Aims: 1. To demonstrate that tDCS combined with upper extremity functional task training in a virtual environment is more effective than functional task training in a virtual environment with sham tDCS. 2. To compare cortico-excitatory changes following training with tDCS vs. sham stimulation, using paired- and single-pulse transcranial magnetic stimulation as a tool to measure cortical excitability.
Detailed description
This is a randomized, double-blinded, sham-controlled study comparing sham and continuous tDCS combined with repetitive upper extremity functional task training in a virtual environment. Subjects will be randomized to 1 of 2 groups: Armeo training with continuous tDCS, or sham tDCS through a randomization stratification approach. Subjects will be grouped into strata defined by the degree of weakness, and then randomized separately within each stratum according to a block randomization of 6 to receive Armeo training-continuous tDCS, or Armeo training-sham stimulation. Each subject will receive 10 training sessions over 2 weeks. Training sessions will last for 40 minutes and will focus on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand. We will use a variety of virtual tasks (computer games) in the training. Examples of the virtual tasks include 1) picking up objects from shelves placed against different walls of a room and placing them in a bin in the center foreground of the screen, 2) picking up eggs from a basket and cracking them over a frying pan, 3) picking up objects at a virtual supermarket and placing them in the shopping cart, 4) cleaning a stove top. In between training sessions, subjects will be encouraged to use the affected arm in daily activities. This will be assessed with the Motor Activity Log. tDCS will be delivered by positioning the anode over the primary motor cortex (M1) of the affected hemisphere, while the cathode will be placed over the unaffected M1 area. The electrode localization method will be according to the International 10-20 Electrode Placement System for placement of EEG electrodes. This method has been validated with a frameless stereotactic system. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2) and delivered by a battery-driven, constant current stimulator with a maximum output of 10mA. An intensity of 1mA will be used in this study (current density of 0.04 μA/cm2). Continuous stimulation will be delivered at an intensity of 1mA while the subject undergoes the 40-minute Armeo motor training sessions. For sham stimulation, the same parameters will be employed. However, the current will be applied for 30 seconds only. Current intensity will be gradually increased and decreased to diminish its perception. Outcome measures will be performed prior to treatment initiation, at day 5, 10, and at follow-up week 1, 2 and 4 after the end of treatment. A rater blinded to the treatment will assess the effects of the intervention using the Jebsen-Taylor Hand Function Test and Box and Block Test.
Interventions
DEVICETranscranial 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.
DEVICESham 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.
DEVICEArmeo training
Upper extremity training with the use of a weight support device and virtual reality.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years * First-time moderate to severe TBI * Arm weakness
Exclusion criteria
* History of seizures * Major depression * Agitated Behavior Scale \>21 * Cognitive Impairment that interferes with understanding instructions * Pregnancy * Implants (e.g. metal plates, shunts, pacemaker) * Participation in other upper extremity rehab or TBI study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Jebsen-Taylor Hand Function Test Score From Baseline | Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post | 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. |
| Change in Box and Block Test Score From Baseline | Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post | The 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. |
Countries
United States
Participant flow
Pre-assignment details
Recruitment target (30) was not reached for this study. Inclusion/exclusion criteria were very restrictive hence making it difficult to recruit subjects.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Armeo Training With Continuous tDCS |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants |
| Age, Continuous | 52.5 years STANDARD_DEVIATION 8 | 52.5 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 2 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Change in Box and Block Test Score From Baseline
The 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.
Time frame: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armeo Training With Continuous tDCS | Change in Box and Block Test Score From Baseline | Day 5 | 2.5 number of blocks | Standard Deviation 3.5 |
| Armeo Training With Continuous tDCS | Change in Box and Block Test Score From Baseline | Day 10 | 3.5 number of blocks | Standard Deviation 3.5 |
| Armeo Training With Continuous tDCS | Change in Box and Block Test Score From Baseline | 1 week post | 3 number of blocks | Standard Deviation 4.2 |
| Armeo Training With Continuous tDCS | Change in Box and Block Test Score From Baseline | 2 weeks post | 1 number of blocks | Standard Deviation 0 |
| Armeo Training With Continuous tDCS | Change in Box and Block Test Score From Baseline | 4 weeks post | 6 number of blocks | Standard Deviation 0 |
Primary
Change in Jebsen-Taylor Hand Function Test Score From Baseline
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.
Time frame: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armeo Training With Continuous tDCS | Change in Jebsen-Taylor Hand Function Test Score From Baseline | Day 5 | -71.9 seconds | Standard Deviation 67.9 |
| Armeo Training With Continuous tDCS | Change in Jebsen-Taylor Hand Function Test Score From Baseline | Day 10 | -79.0 seconds | Standard Deviation 66.6 |
| Armeo Training With Continuous tDCS | Change in Jebsen-Taylor Hand Function Test Score From Baseline | 1 week post | -20.1 seconds | Standard Deviation 151.2 |
| Armeo Training With Continuous tDCS | Change in Jebsen-Taylor Hand Function Test Score From Baseline | 2 weeks post | -17.4 seconds | — |
| Armeo Training With Continuous tDCS | Change in Jebsen-Taylor Hand Function Test Score From Baseline | 4 weeks post | -26.9 seconds | — |