Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation
DeviceThe 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: NeurofeedbackExperimental treatment 1 intervention
Group B: Sham TreatmentSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and again every two weeks through end of treatment, average of 6 weeksSecondary outcomes
1
Stimulation Related Sensations Questionnaire (SRSQ)
The SRSQ will be administered to participants after the LIP-tES or sham session is complete. Results will be used to assess if participants report different sensations across conditions to examine if sham condition is appropriate control condition.
Time frame
Baseline treatment visit2
Change from Baseline in Neurobehavioral Symptom Inventory (NSI)
The NSI will be administered as a measure of general post-concussive symptoms
Time frame
Baseline and again at study completion, an average of 6 weeks3
Change from Baseline in Headache Impact Test (HIT-6)
The HIT-6 will be administered to measure changes in headache frequency and severity over prior month.
Time frame
Baseline and again at study completion, an average of 6 weeks4
Qualitative Assessment of Study Recruitment Capability
Qualitative assessment of ability to recruit participants into the study by examining recruitment rates and reported obstacles to recruitment over study period. Assessment will result in decision that recruitment capabilities are suitable or unsuitable for additional study with no change to targeted population with same inclusion/exclusion criteria.
Time frame
End of study data collection, approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov