Phase
Condition
Learning Disorders
Memory Loss
Brain Injury
Treatment
tDCS in Youth with mild traumatic brain injury
Clinical Study ID
Ages 10-15 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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, andexecuting 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
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 theelectrodes before the start of the stimulation.
Parent/guardian report metal implants anywhere in the head/ncek/body on the MRIscreening 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, cochlearimplant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, anyimplant held in place with a magnet, heart valve, or deep brain stimulator on theMRI screening form.
Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on theMRI 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 ametal 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 separatepost-consent screening form at each MRI visit to ensure the female reportsaccurately 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 MRIscreening 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, cochlearimplant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, anyimplant held in place with a magnet, heart valve, or deep brain stimulator on theMRI screening form.
Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on theMRI 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 ametal 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-consentscreening form at each MRI visit to ensure the female reports accurately withoutfear.
Study Design
Study Description
Connect with a study center
Ghazala Saleem
Buffalo, New York 14214
United StatesActive - Recruiting
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