Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

NCT ID: NCT05762796

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2027-06-30

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.

Detailed Description

About 1.9 million children sustain mTBI per year from sports injuries alone in the US. In about 30% of children, the cognitive-motor effects of mTBI interrupt typical neurodevelopment leading to chronic neurological conditions. The limited evidence available on mTBI suggests that residual symptoms may involve the brain stem (BS); the subcortical region that is now shown to influence cognitive-motor control. The BS also has functional interconnections to other cortical regions involved in cognitive-motor learning such as the dorsolateral prefrontal cortex, premotor cortex, and primary motor cortex. While clinicians examine certain risk factors such as amnesia and history of prior concussions, they lack objective biomarkers to accurately predict the post-mTBI prognosis in children, and to accurately guide treatment. Further, there is no evidence-based standard of care established, so children may be released to pre-injury activity levels before full neurophysiological recovery, predisposing them to further mTBI and associated sequelae.

Transcranial Direct Current Stimulation (tDCS), a non-invasive treatment, has been demonstrated to positively influence cognitive-motor control by modulating the excitability of both cortical and subcortical structures. Additionally, resting state functional connectivity has shown promise in diagnosing and predicting recovery in adult TBI. However, the efficacy of tDCS for children with mTBI is not yet established due to their atypical cortical activity and variable symptomology. Consequently, we aim to determine the efficacy of tDCS for promoting recovery in 10 youths (aged 10 to 15 years) who exhibit persistent symptoms of mTBI using a cross-over design compared with 10 never-injured youths as controls, and to test the application of neural correlates to provide insights into their functional change and recovery by comparing group differences.

Conditions

Brain Concussion; Mild Traumatic Brain Injury; Motor Disorders; Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

tDCS in Youth with mild traumatic brain injury

Intervention Type: 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)

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)

Intervention Type: DEVICE

Eligibility Criteria

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:

• 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:

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Ghazala Tanveer Saleem

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghazala Saleem, EdD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

Ghazala Saleem

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ghazala Saleem, EdD

Role: CONTACT

GHAZALAS@BUFFALO.EDU

716-829-2589

Facility Contacts

Ghazala Saleem, EdD

Role: primary

GHAZALAS@BUFFALO.EDU

7168292589

Role: backup

GHAZALAS@BUFFALO.EDU

References

Saleem GT, Crasta JE, Slomine BS, Cantarero GL, Suskauer SJ. Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):724-738. doi: 10.1016/j.apmr.2018.10.011. Epub 2018 Nov 7.

Reference Type: BACKGROUND

PMID: 30414398 (View on PubMed)

Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

Reference Type: BACKGROUND

PMID: 21320389 (View on PubMed)

Rotter J, Kamat D. Concussion in Children. Pediatr Ann. 2019 Apr 1;48(4):e182-e185. doi: 10.3928/19382359-20190326-01.

Reference Type: BACKGROUND

PMID: 30986320 (View on PubMed)

Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.

Reference Type: BACKGROUND

PMID: 25983531 (View on PubMed)

Other Identifiers

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006696

Identifier Type: -

Identifier Source: org_study_id