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New treatment option for Brain Concussion
Official title Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
ClinicalTrials.gov ID: NCT05762796
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 15. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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:
- 10 to 15 years old
- no concussion history
- Parent and child proficient in English Experimental Cohort:
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 15 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.