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Neurofeedback for Concussion-Related Light Sensitivity

N/A
Recruiting
Led By Francesca C Fortenbaugh, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-65
Documented symptoms of photosensitivity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study data collection, approximately 2 years
Awards & highlights

Study Summary

This trial aims to test a brain stimulation treatment to reduce the symptoms of light sensitivity in veterans with mild brain injuries. It will also measure brain activity in scans.

Who is the study for?
This trial is for veterans aged 18-65 with a history of mild traumatic brain injury (mTBI) at least 6 months old and symptoms of light sensitivity. They must have had an eye exam in the last year showing good vision, normal eye functions, and no major eye issues. People with certain eye conditions, neurological diseases like Parkinson's or MS, seizures, motor tics, or those on drugs affecting eyesight/photosensitivity can't join.Check my eligibility
What is being tested?
The study tests a Micro Current Neurofeedback Device using low-frequency electrical stimulation to see if it helps reduce light sensitivity in people with mTBI. Participants will also undergo MRI scans to look for changes in the brain related to this treatment.See study design
What are the potential side effects?
While specific side effects are not detailed here, similar neurofeedback treatments may cause temporary discomforts such as headache or dizziness. The use of transcranial electrical stimulation could potentially lead to skin irritation where applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I experience severe reactions to sunlight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study data collection, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study data collection, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Utah Photophobia Symptom Impact Scale (UPSIS)
Secondary outcome measures
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS)
Change from Baseline in Headache Impact Test (HIT-6)
Change from Baseline in Neurobehavioral Symptom Inventory (NSI)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NeurofeedbackExperimental Treatment1 Intervention
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.
Group II: Sham TreatmentPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,465 Total Patients Enrolled
Francesca C Fortenbaugh, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
~24 spots leftby Nov 2025
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