RECRUITING

Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury

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Conditions

Mild Traumatic Brain InjuryPhotophobia

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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

The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.

Official Title

A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury

Quick Facts

Study Start:2024-01-01
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06109909

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18-65
  2. * Documented history of mTBI at least 6 months prior to initial study visit
  3. * Documented symptoms of photosensitivity
  4. * Eye exam within the last 12 months documenting best-corrected acuity of 20/20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test
  1. * History of strabismus or amblyopia
  2. * Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes
  3. * Previous or current history of retinal or optic nerve pathology in one or both eyes
  4. * History of stroke and/or visual neglect
  5. * History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)
  6. * History of epilepsy or seizures
  7. * History of motor tics
  8. * Current use of medications or substances that may severely affect pupillary response and/or increase photosensitivity
  9. * Individuals with impaired decision-making capacity
  10. * Illiterate or no English language proficiency

Contacts and Locations

Study Contact

Francesca C Fortenbaugh, PhD
CONTACT
(857) 364-4362
Francesca.Fortenbaugh@va.gov

Principal Investigator

Francesca C Fortenbaugh, PhD
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Francesca C Fortenbaugh, PhD, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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 Date2024-01-01
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • photophobia
  • mild traumatic brain injury

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury
  • Photophobia