About this trial
Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 10-15 years at enrollment
enrolled after 6 weeks of mTBI injury
exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)
Sustained an mTBI or concussion within the past 12 months
Disqualifiers
loss of consciousness > 30 minutes
post-traumatic amnesia > 24 hours
intracranial findings on clinical imaging
history of developmental delay
Trial design
Crossover
Treatments tested in this trial
tDCS in Youth with mild traumatic brain injury
DeviceThe safety and tolerability of tDCS have been established in children with mTBI (1). A recent study of 13-18 year youths post-mTBI showed that three sessions of 1.5 mA anodal tDCS over the left DLPFC, positively influenced prolonged working memory deficits. (2) Additionally, rodent studies show the effectiveness of tDCS in improving cognitive-motor (motor planning and balance/gait) function in rats with mTBI. (3)
Treatment groups
Trial outcomes
Primary outcomes
Changes in the Revised Physical and Neurological Examination of Subtle Signs (PANESS - Gaits and Stations Measures)
The PANESS is used to assess static and dynamic postural stability of adolescents. The PANESS contains nine static and dynamic balance tasks: 1) walking on heels, 2) walking on toes, 3) walking on sides of feet, 4) double-legged stance, 5) single-legged stance for 30 seconds, 6) tandems stance for 20 seconds, 7) forward tandem walking, 8) backward tandem walking, and 9) hopping in place on one foot. The scores from all tasks are combined to form an aggregated score.
Changes in the Nine-Hole Peg Test
The test consists of a square board with 9 holes. The participants are asked to pick up pegs one at a time and place them into holes as quickly as possible. The participants are then instructed to remove the pegs one by one from the board and put them back into the container. The average time from four trials is examined to arrive at the total score.
Changes in the Dual-Task Screen
It consists of a gait task and an eye-hand coordination task. In the single gait task condition, participants are instructed to walk as quickly as possibly for 6 meter and step over a 1.5 meter obstacle placed 4 meter from the start. In the dual gait condition, participants will repeat the gait task while counting the months of the year backward. In the eye-hand coordination single task, participants will be instructed to stand 1.5 meter away from the wall and throw and catch a tennis ball for 30 seconds. In the dual task eye-hand coordination condition, the participants will repeat the catch and throw task while serially subtracting 3s from 100s. The difference between the single task and the dual task will be calculated to arrive at the score for each participant.
Changes in Motor Control Test Measurements (Posturography)
The motor control test (MCT) will be administered using the Posturography Machine to assess the ability of the patient to recover from translational disturbances of the support surface. The six conditions each participant will perform include three forward translations with small, medium, and large intensities as well as three backward translations with small, medium, and large intensities. Each participant go through three trials at each translation and intensity. The participant will be scored on latency; their ability to respond to the translation in milliseconds, and the amplitude scaling; the average amount of weight carried by each leg during the translation. An increased latency indicates impairment within the neural pathways that cause musculoskeletal problems in addition to central abnormalities. Abnormal amplitude scaling indicates inadequate or asymmetrical level of force exerted during the recovery from the support disturbance.
Secondary outcomes
Changes in PHQ-8
This 8-item questionnaire assesses depression in children. The scores of all variables will be aggregated to form a total score.
Changes in GAD-7
This 7-item questionnaire assesses anxiety in children. The scores of all variables will be aggregated to form a total score.
Changes in WASI-II
This measure assesses overall cognitive abilities in children. The scores of all variables will be aggregated to form a total score.
Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator