Recruiting

Neurofeedback

Sponsor:

VA Office of Research and Development

Code:

NCT06109909

Conditions

Mild Traumatic Brain Injury

Photophobia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation

Study Details

Brief 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.

Conditions

Mild Traumatic Brain Injury

Photophobia

Study ID

NCT06109909

Start date

Jan 1, 2024

Status verified date

Dec, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of strabismus or amblyopia
  • Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes
  • Previous or current history of retinal or optic nerve pathology in one or both eyes
  • History of stroke and/or visual neglect
  • History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)
  • History of epilepsy or seizures
  • History of motor tics
  • Current use of medications or substances that may severely affect pupillary response and/or increase photosensitivity
  • Individuals with impaired decision-making capacity
  • Illiterate or no English language proficiency

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation

The EEG interface device is a J\&J Engineering 1-330 C2 box. The software used to determine LIP-tES feedback patterns was developed by Neurogen High Performance Neurofeedback. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+,A-,B+,B-), with respect to the Common Neck Reference. During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scale to record EEG signals. All four (A+,A-,B+,B-) electrodes are involved in applying weak electrical pulses back to the brain (feedback process). The brief feedback pulse (\~100mV) is adaptive and determined based on the offset of the frequency spectrum recorded across the left and right hemisphere (A vs. B) electrodes in the time window immediately prior to stimulation.

Primary outcome measure

  • Change in Utah Photophobia Symptom Impact Scale (UPSIS) [ Time Frame: Baseline and again every two weeks through end of treatment, average of 6 weeks ]

Central Contacts and Locations

Central contacts

Francesca C Fortenbaugh, PhD

(857) 364-4362Francesca.Fortenbaugh@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Francesca C Fortenbaugh, PhD

857-364-4362Francesca.Fortenbaugh@va.gov

Principal Investigator:

Francesca C Fortenbaugh, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • photophobia
  • mild traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-16.