A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Ages 18-65

• Documented history of mTBI at least 6 months prior to initial study visit

• Documented symptoms of photosensitivity

• 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

Locations
United States
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Contact Information
Primary
Francesca C Fortenbaugh, PhD
Francesca.Fortenbaugh@va.gov
(857) 364-4362
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 36
Treatments
Experimental: Neurofeedback
Half of the participants will be blindly assigned to receive 12 sessions of LIP-tES intervention over 6 weeks. A subset of these participants will also complete a resting-state MRI scan during the initial session (prior to LIP-tES intervention) and after their final LIP-tES intervention.
Sham_comparator: Sham Treatment
Half of the participants will be blindly assigned to receive 12 sessions of a sham intervention that will mirror all aspects of the LIP-tES intervention except that no neurofeedback pulses will be delivered. A subset of these participants will also complete a resting-state MRI scan at the beginning of the initial session and at the end of the 12th session.
Related Therapeutic Areas
Concussion
Traumatic Brain Injury
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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