Clinical trial NCT06109909: Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
Official title: A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Photophobia
Keywords: photophobia
mild traumatic brain injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Photosensitivity (PS) is one of the more common sequelae of TBI, with over 50% of TBI patients reporting some level of PS in the acute and/or chronic stages. PS can range from mild to severe and can significantly impair social, physical, and cognitive functioning, as well as rehabilitation outcomes. While spectacle chromatic filters are conventionally used to alleviate symptoms, they are not designed to resolve issues with PS and have been associated with lower symptom recovery over time, underscoring the need to develop more effective, non-invasive treatment options that can reduce or eliminate PS. Recent work has shown that neurofeedback interventions, such as Low Intensity Pulse-Based Transcranial Electrical Stimulation (LIP-tES) may be effective in treating post-concussive symptoms and a preliminary case study from the investigators' research group suggests that LIP-tES may also be able to reduce PS symptoms in Veterans with a history of mild TBI. However, both the mechanism by which LIP-tES alters brain activity and alleviates symptoms across a range of disorders remains unclear as does the neurobiological basis of PS associated with mTBI and psychiatric comorbidities commonly seen in today's Veteran population. These knowledge gaps represent important limitations both for the clinical characterization of PS in Veterans and development/optimization of novel treatment options. This proposal will take an important first step in addressing these two important knowledge gaps. Aim 1: Complete a preliminary study testing the feasibility and acceptability of a novel LIP-tES intervention designed to reduce severity of PS in patients with a history of mTBI. Extending a recent case study completed by the investigators' research group, the investigators will complete a pilot study of LIP-tES for the treatment of PS in Veterans with a history of mTBI. The investigators will track recruitment capability (participants screened vs. enrolled, attrition rates and reasons for attrition), acceptability and suitability of the intervention, evaluate suitability of the sham procedure the investigators developed, and gain preliminary evaluation of participant responses to the intervention. Aim 2: Assess neurophysiological markers of PS and changes associated with LIP-tES intervention using resting-state fMRI. A subset of the participants will complete two MRI scans during the initial visit after the last LIP-tES or sham session. Preliminary work from the investigators' laboratory has identified a sparse connectome of regions that are predictive of moderate/severe PS ratings in a polymorbid sample of Veterans from the Translational Research Center for TBI and Stress Disorders (TRACTS) longitudinal cohort study. Extending this work, the investigators will test whether classification models using this previously identified connectome will correctly identify individuals who report a reduction in PS after treatment and whether connections are predictive of PS severity. By examining resting-state functional connectivity prior to and after completion of LIP-tES, the proposed study aims to increase the understanding of the underlying pathophysiological mechanisms of PS in mTBI and the mechanism by which LIP-tES may alleviate these symptoms.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Utah Photophobia Symptom Impact Scale (UPSIS)
timeFrame: Baseline and again every two weeks through end of treatment, average of 6 weeks
Secondary outcomes:
measure: Stimulation Related Sensations Questionnaire (SRSQ)
timeFrame: Baseline treatment visit
measure: Change from Baseline in Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline and again at study completion, an average of 6 weeks
measure: Change from Baseline in Headache Impact Test (HIT-6)
timeFrame: Baseline and again at study completion, an average of 6 weeks
measure: Qualitative Assessment of Study Recruitment Capability
timeFrame: End of study data collection, approximately 2 years
measure: Qualitative Assessment of Acceptability of Data Collection Methods
timeFrame: End of study data collection, approximately 2 years
measure: Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline and again at study completion, an average of 6 weeks
measure: Change from Baseline in Depression, Anxiety, and Stress Scale (DASS)
timeFrame: Baseline and again at study completion, an average of 6 weeks
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and again at study completion, an average of 6 weeks
measure: Change from Baseline in Short Form McGill Pain Questionnaire
timeFrame: Baseline and again at study completion, an average of 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Francesca C Fortenbaugh, PhD
role: PRINCIPAL_INVESTIGATOR
References: