Recruiting

NeuromodulationNeuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Sponsor:

State University of New York at Buffalo

Code:

NCT05762796

Conditions

Brain Concussion

Mild Traumatic Brain Injury

Motor Disorders

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Accepted

Interventions

tDCS in Youth with mild traumatic brain injury

Study Details

Brief summary:

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.

Conditions

Brain Concussion

Mild Traumatic Brain Injury

Motor Disorders

Cognitive Impairment

Study ID

NCT05762796

Start date

Feb 20, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Accepted

Experimental Cohort:

Inclusion Criteria:

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

Healthy Controls Cohort:

Inclusion Criteria:

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

Experimental Cohort:

Exclusion Criteria:

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.

Healthy Controls Cohort:

Exclusion Criteria:

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Healthy Controls

Never-concussed age-and gender-matched healthy controls will not receive any intervention. Behavioral and neuroimaging measurements will be administered only once, at the initial visit.

experimental: tDCS in Youth with mild traumatic brain injury

Behavioral as well as neuroimaging measurements will be administered at the final post-anodal transcranial direct current stimulation (tDCS), final post-sham tDCS, and at 30-day follow-up visits.

tDCS will be administered after the initial behavioral and neuroimaging testing. Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS will be administered using Neurocom (Germany) DC stimulator and two 5x7 electrodes, moistened in saline solution, to 10 participants with mTBI following a cross-over design with a 2-week washout period. The location of the brain regions will be determined using either the Transcranial Magnetic Stimulation Neuronavigation or Brainsight Neuronavigation system. The anode will be placed over pre-determined brain regions, whereas the cathode will be placed either over Fp2 (contralateral supraorbital) or other suitable reference areas.

Interventions

tDCS in Youth with mild traumatic brain injury

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)

Primary outcome measure

Changes in the Revised Physical and Neurological Examination of Subtle Signs (PANESS - Gaits and Stations Measures) [ 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). ]
Changes in the Nine-Hole Peg Test [ 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). ]
Changes in the Dual-Task Screen [ 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). ]
Changes in Motor Control Test Measurements (Posturography) [ 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). ]
Changes in resting-state functional magnetic resonance imaging outcome [ Time Frame: Day 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). ]

Central Contacts and Locations

Central contacts

Ghazala Saleem, EdD

716-829-2589 GHAZALAS@BUFFALO.EDU

Locations

Ghazala Saleem

Recruiting

Buffalo, New York, United States, 14214

Contacts

Ghazala Saleem, EdD

7168292589 GHAZALAS@BUFFALO.EDU

GHAZALAS@BUFFALO.EDU

Principal Investigator:

Ghazala Saleem, EdD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Keywords

Brain Concussion
Mild Traumatic Brain Injury
Child
Motor Activity
Cognitive Impairment
Transcranial Direct Current Stimulation
Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-02-03.