Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT06109909
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury
  • Photophobia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Francesca C Fortenbaugh, PhD
[email protected]
857-364-4362
Francesca C Fortenbaugh, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MA

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