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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 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

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,248 Total Patients Enrolled

Francesca C Fortenbaugh, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How may I join this medical research program?

"Desirable candidates for this study must be afflicted with light-intolerance and possess a chronological age between 18 and 65 years. Approximately 36 participants are being recruited in total."

Answered by AI

Does this clinical trial permit individuals under 25 years of age to enroll?

"Patients must meet the age criteria of 18 - 65 to join this clinical trial. For those younger or older, there are 182 and 780 studies respectively that may be suitable for them."

Answered by AI

Is this scientific investigation accepting new participants?

"According to the clinicaltrials.gov webpage, this particular medical trial is not actively accepting applicants at present. It was first made available on December 1st 2023 and its most recent update occurred on October 25th 2023. However, there are presently 1009 other trials searching for participants worldwide."

Answered by AI