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Neuromodulation and Neuroimaging for Children with Mild Traumatic Brain Injury

This study is looking at a brain stimulation method called transcranial direct current stimulation (tDCS) for children aged 10-15 who have had a mild traumatic brain injury (mTBI), also known as a concussion. The goal is to see if tDCS can help improve motor skills and thinking abilities that might be affected after a concussion. Researchers will measure changes in walking, hand dexterity, and how well children can do two tasks at once. You might be able to join if you are 10-15 years old, had a concussion within the last year, and are still having symptoms like difficulty with planning or movement. The study plans to enroll 10 participants.

Study design
This is an interventional study that plans to enroll 10 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have visits on Day 1, Day 26-30, Day 60-64, and Day 94. These visits will involve assessments of walking, hand dexterity, and dual-task abilities.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after the final sham tDCS treatment, with a final visit around Day 94.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05762796

Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Recruiting
NAAges 10–15InterventionalTreatment
State University of New York at Buffalo
~10 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:tDCS in Youth with mild traumatic brain injury

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in the Revised Physical and Neurological Examination of Subtle Signs (PANESS - Gaits and Stations Measures)
Measured over 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 more outcomes measured

Conditions

Brain Concussion
Mild Traumatic Brain Injury
Motor Disorders
Cognitive Impairment

Explore related trials

Cognitive DysfunctionConcussionMotor Disorders

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ghazala Saleem, EdD · PRINCIPAL_INVESTIGATOR · State University of New York at Buffalo

Who to contact

Ghazala Saleem, EdD
[email protected]
716-829-2589
Email the study team

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Eligibility criteria

Inclusion

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
Parent and child proficient in English
10 to 15 years old
no concussion history
Parent and child proficient in English

Exclusion

loss of consciousness \> 30 minutes
post-traumatic amnesia \> 24 hours
intracranial findings on clinical imaging
history of developmental delay
history of learning disability or ADHD
Sustained a lower limb or upper limb injury that has not healed
History of Seizures
Noticeable skin lesions/burns or any other severe skin problems at the site of the electrodes before the start of the stimulation.
Parent/guardian report metal implants anywhere in the head/ncek/body on the MRI screening form (see attached).
Parent/guardian report shrapnel/bullets in the body on the MRI screening form.
Parent/guardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.
Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.
Parent/guardian report being claustrophobic on the MRI screening form.
Parent/guardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.
Pregnant females as reported by parent/guardian on the pre-consent screening form. Pubertal/post-pubertal female participants14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.
diagnosed with developmental delay
sustained a lower limb or upper limb injury that has not healed
history of Learning Disability and/or ADHD
Parent/guardian report metal implants anywhere in the head/ncek/body on the MRI screening form (see attached).
Parent/guardian report shrapnel/bullets in the body on the MRI screening form.
Parent/guardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.
Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.
Parent/guardian report being claustrophobic on the MRI screening form.
Parent/guardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.
Pregnant females as reported by parent/guardian on the pre-consent screening form. Post-pubertal females 14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.

What this trial measures

  • Changes in the Revised Physical and Neurological Examination of Subtle Signs (PANESS - Gaits and Stations Measures)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).

    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 TestDay 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).

    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 ScreenDay 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).

    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)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).

    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.

  • Changes in resting-state functional magnetic resonance imaging outcomeDay 2-5 (post initial behavioral testing), Day 26- 32 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -66 (final post-sham tDCS), and Day 94 - 96 (post 30-days follow up behavioral testing visit).

    MRI scanning will be used to assess the functional connectivity among the brain areas involved in motor learning and motor planning. Functional connectivity will be measured by looking at differences in the control group and the experimental group.