Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-15
SponsorState University of New York at Buffalo

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • tDCS in Youth with mild traumatic brain injury

    Device

    The 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

10 Participants
are divided into 2 treatment groups
Group A: Healthy ControlsNo intervention 0 interventions
Group B: tDCS in Youth with mild traumatic brain injuryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).
2

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).
3

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).
4

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).

Secondary outcomes

1

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).
2

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).
3

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.

Time frame
Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator