Mild Traumatic Brain Injury Clinical Trial
Official title:
A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline treatment visit | |
Secondary | Change from Baseline in Neurobehavioral Symptom Inventory (NSI) | The NSI will be administered as a measure of general post-concussive symptoms | Baseline and again at study completion, an average of 6 weeks | |
Secondary | 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. | Baseline and again at study completion, an average of 6 weeks | |
Secondary | 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. | End of study data collection, approximately 2 years | |
Secondary | Qualitative Assessment of Acceptability of Data Collection Methods | Qualitative assessment of the suitability of data collection procedures by examining the retention and follow-up rates as the participants moved through the study and intervention, adherence rates to study procedures, barriers to study participation reported by participants over the course of the study. Assessment will result in decision that current study protocol is suitable or unsuitable for additional study with no change to study design. | End of study data collection, approximately 2 years | |
Secondary | Change from Baseline in PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 will be administered to measure changes in PTSD symptom severity. | Baseline and again at study completion, an average of 6 weeks | |
Secondary | Change from Baseline in Depression, Anxiety, and Stress Scale (DASS) | The DASS questionnaire will be administered to measure changes in severity of depression, anxiety, and stress symptoms. | Baseline and again at study completion, an average of 6 weeks | |
Secondary | Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) | The PSQI will be administered to provide a measure of changes in global sleep quality. | Baseline and again at study completion, an average of 6 weeks | |
Secondary | Change from Baseline in Short Form McGill Pain Questionnaire | This questionnaire will be administered to provide a general measure of changes in chronic pain. | Baseline and again at study completion, an average of 6 weeks |
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