NCT05762796

Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2024-02-20
• Primary completion: 2027-03-31
• Completion: 2027-06-01
• First posted: 2023-03-10
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study