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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study data collection, approximately 2 years

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe eye condition that affects my vision.

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I have had eye problems related to the retina or optic nerve.

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I have had a stroke or experience visual neglect.

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I have a history of a neurodegenerative disease like Parkinson's or multiple sclerosis.

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I am not taking any medications that affect my pupils or make my skin more sensitive to light.

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I am unable to make decisions for myself.

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study data collection, approximately 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Utah Photophobia Symptom Impact Scale (UPSIS)

Secondary study objectives

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.

0 / 9Eligibility criteria met