Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury

NCT06109909 | Recruiting

• 1 other identifier: C4374-P
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

photophobia; mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Change in Utah Photophobia Symptom Impact Scale (UPSIS)

  The UPSIS questionnaire is a 17-item questionnaire designed to quantitatively assess photosensitivity symptoms and their impact on activities of daily living. Scores range from 0-80 with higher values indicating more severe photosensitivity symptoms.

  Baseline and again every two weeks through end of treatment, average of 6 weeks

Secondary Outcomes (9)

• Stimulation Related Sensations Questionnaire (SRSQ)

  Baseline treatment visit

• Change from Baseline in Neurobehavioral Symptom Inventory (NSI)

  Baseline and again at study completion, an average of 6 weeks

• Change from Baseline in Headache Impact Test (HIT-6)

  Baseline and again at study completion, an average of 6 weeks

• Qualitative Assessment of Study Recruitment Capability

  End of study data collection, approximately 2 years

• Qualitative Assessment of Acceptability of Data Collection Methods

  End of study data collection, approximately 2 years

Study Arms (2)

Neurofeedback

EXPERIMENTAL

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.

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

Sham Treatment

SHAM COMPARATOR

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.

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

Interventions

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

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.

Also known as: LIP-tES intervention

Neurofeedback; Sham Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Photophobia

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca C Fortenbaugh, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca C Fortenbaugh, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham treatment, single-blind design. During the sham treatment, we will prep and place electrodes in the same manner as participants receiving the LIP-tES treatment. However, no LIP-tES pulses will be sent from the system during the sham treatment. The operator will know which group the participant is assigned to but all aspects of study design and data collection will be the same from the perspective of the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: After consent, participants will be randomly assigned to either the LIP-tES intervention or sham control group. Participants will complete 12 sessions over 6 weeks during which photosensitivity symptoms will be tracked using the Utah Photophobia Symptom Impact Scale (UPSIS). A subset of participants will also complete a resting-state MRI scan session during the initial visit and again during the 12th visit. A follow-up phone call will be placed after a 6 week wash-out period. Group assignment will be disclosed at this time and participants in the sham condition who would like to receive the LIP-tES intervention will be able to return for an additional 12 sessions over 6 weeks during which they will receive LIP-tES and photosensitivity symptoms will be tracked using the UPSIS questionnaire.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)