RECRUITING

Neuromodulation and Neuroimaging in Older Children with Mild Traumatic Brain Injury

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Conditions

Brain ConcussionMild Traumatic Brain InjuryMotor DisordersCognitive ImpairmentChildMotor ActivityTranscranial Direct Current StimulationNeuroimaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05762796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * age 10-15 years at enrollment
  2. * enrolled after 6 weeks of mTBI injury
  3. * exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)
  4. * Sustained an mTBI or concussion within the past 12 months
  5. * Parent and child proficient in English
  1. * loss of consciousness \> 30 minutes
  2. * post-traumatic amnesia \> 24 hours
  3. * intracranial findings on clinical imaging
  4. * history of developmental delay
  5. * history of learning disability or ADHD
  6. * Sustained a lower limb or upper limb injury that has not healed
  7. * History of Seizures
  8. * Noticeable skin lesions/burns or any other severe skin problems at the site of the electrodes before the start of the stimulation.
  9. * Parent/guardian report metal implants anywhere in the head/ncek/body on the MRI screening form (see attached).
  10. * Parent/guardian report shrapnel/bullets in the body on the MRI screening form.
  11. * 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.
  12. * Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.
  13. * Parent/guardian report being claustrophobic on the MRI screening form.
  14. * 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.
  15. * 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.

Contacts and Locations

Study Contact

Ghazala Saleem, EdD
CONTACT
716-829-2589
GHAZALAS@BUFFALO.EDU

Principal Investigator

Ghazala Saleem, EdD
PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo

Study Locations (Sites)

Ghazala Saleem
Buffalo, New York, 14214
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • Ghazala Saleem, EdD, PRINCIPAL_INVESTIGATOR, State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Brain Concussion
  • Mild Traumatic Brain Injury
  • Child
  • Motor Activity
  • Cognitive Impairment
  • Transcranial Direct Current Stimulation
  • Neuroimaging

Additional Relevant MeSH Terms

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