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
State University of New York at Buffalo
10 participants
Feb 20, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- Experimental Cohort:
- 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:
- to 15 years old
- no concussion history
- Parent and child proficient in English
- Experimental Cohort:
Exclusion Criteria26
- 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.
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Interventions
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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05762796