Neurofeedback for Concussion-Related Light Sensitivity

Overseen By Francesca C Fortenbaugh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Photosensitivity drugs

Disqualifiers: Stroke, Neurodegenerative disease, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 6 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new neurofeedback treatment to reduce light sensitivity in Veterans with mild traumatic brain injury (mTBI). The treatment uses the Micro Current Neurofeedback Device, which sends low-intensity electrical pulses to the brain. Researchers aim to determine if this approach is effective and acceptable for those with light sensitivity. Participants must have a history of mTBI, ongoing light sensitivity, and a recent eye exam showing no major vision problems. As an unphased trial, this study offers Veterans the chance to explore a novel treatment option for light sensitivity.

Will I have to stop taking my current medications?

The trial excludes participants who are currently using medications or substances that may severely affect pupillary response or increase photosensitivity, so you may need to stop taking such medications to participate.

What prior data suggests that this neurofeedback device is safe for reducing photosensitivity in Veterans with mTBI?

Research shows that treatments using low-intensity pulse-based transcranial electrical stimulation (LIP-tES) are generally well-tolerated. Studies with similar devices have found that most people do not experience serious side effects. Reports from past studies on microcurrent neurofeedback, a type of LIP-tES, suggest it has been safely used in adults with conditions like depression, anxiety, and PTSD (post-traumatic stress disorder).

This study serves as an early test, meaning it is smaller and lacks a phase designation. However, similar treatments have been used without major problems. Participants in previous trials have mostly reported mild and temporary side effects, if any. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for concussion-related light sensitivity involve rest and gradual return to normal activities, sometimes supplemented by pain relievers. However, this new approach, using Micro Current Neurofeedback, is unique because it employs low-frequency pulse-based transcranial electrical stimulation (LIP-tES). This technique aims to directly modulate brain activity, potentially providing faster and more targeted relief from light sensitivity. Researchers are excited about this treatment because it offers a non-invasive method that could adjust neural pathways, which might lead to improved outcomes compared to traditional methods.

What evidence suggests that this neurofeedback device is effective for reducing light sensitivity in mTBI patients?

Research has shown that microcurrent neurofeedback, which uses gentle electrical signals, may help reduce symptoms in people with mild traumatic brain injury (mTBI). One study found that participants experienced up to a 61% reduction in post-concussion symptoms, such as sensitivity to light, after receiving this type of brain stimulation. In this trial, half of the participants will receive the Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation (LIP-tES) to evaluate its effectiveness in reducing light sensitivity. Other studies suggest that this neurofeedback can also help with symptoms of depression, anxiety, and PTSD (post-traumatic stress disorder). While more research is needed, these early findings are promising for reducing light sensitivity in people who have had a concussion. ^{1 3 4 5 6}

Who Is on the Research Team?

Francesca C Fortenbaugh, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had a mild traumatic brain injury over 6 months ago.

I experience severe reactions to sunlight.

Your last eye exam in the past year showed that you can see really well, your eyes work normally, and there were no problems found in specific eye tests.

Exclusion Criteria

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

I have had a stroke or experience visual neglect.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of LIP-tES or sham intervention over 6 weeks

6 weeks

12 visits (in-person)

Neurophysiological Assessment

Participants undergo resting-state MRI scans to assess neurophysiological markers of photosensitivity

1 session

2 visits (in-person)

Follow-up

Participants are monitored for changes in photosensitivity and other symptoms post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Neurofeedback Experimental Treatment 1 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 Treatment Placebo Group 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Neurofeedback, a type of biofeedback, shows promise in treating symptoms of traumatic brain injury (TBI) by helping patients learn to control their physiological responses, although more rigorous studies are needed to confirm its efficacy.

Preliminary data from a pilot study suggests that using a commercial neurofeedback device may improve motivation for treatment and reduce symptoms related to attention, mood, and mindfulness in patients with mild-to-moderate TBIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of the Use of Neurofeedback Biofeedback for the Treatment of Symptoms of Traumatic Brain Injury in Military and Civilian Populations. Gray, SN.[2020]

Electroencephalogram biofeedback (EBF) is recognized as a clinically effective treatment for ADHD, seizure disorders, anxiety, depression, and traumatic brain injury, meeting the 'Clinical Guidelines' standard set by the American Academy of Child and Adolescent Psychiatry.

Repetitive transcranial magnetic stimulation (rTMS) is also endorsed under 'Clinical Guidelines' for treating bipolar disorder, unipolar disorder, and schizophrenia, indicating its efficacy in managing these mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging brain-based interventions for children and adolescents: overview and clinical perspective. Hirshberg, LM., Chiu, S., Frazier, JA.[2009]

In a randomized controlled trial involving 21 patients with Tourette syndrome, electrodermal biofeedback training did not show a significant advantage over sham feedback in reducing tic frequency or improving well-being after 4 weeks of treatment.

The study suggests that the short duration of training sessions may have limited the effectiveness of biofeedback, indicating that further research is needed to optimize training schedules for potential benefits in managing tics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial. Nagai, Y., Cavanna, AE., Critchley, HD., et al.[2022]

Neurofeedback is gaining popularity as an alternative treatment for various neurological disorders, including epilepsy, despite limited insurance coverage.

The individual progress of three children with epilepsy spectrum disorder who underwent neurofeedback training suggests potential therapeutic benefits, highlighting the need for further exploration of this modality in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical neurofeedback: case studies, proposed mechanism, and implications for pediatric neurology practice. Legarda, SB., McMahon, D., Othmer, S., et al.[2011]

A case study demonstrated that EEG-based neurofeedback significantly improved attention, visuospatial skills, and processing speed in a patient with severe traumatic brain injury compared to conventional neuropsychological rehabilitation.

The positive outcomes were supported by quantitative EEG changes, suggesting that EEG-based neurofeedback could be a valuable addition to traditional rehabilitation methods for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in a case of traumatic brain injury using EEG-based neurofeedback in comparison to conventional methods. Arroyo-Ferrer, A., Noreña, D., Serrano, JI., et al.[2022]

Transcranial direct current stimulation (tDCS) showed promising early efficacy in improving working memory performance in youth with cognitive persistent post-concussion symptoms, particularly on a dual task working memory test.

The study found that participants tolerated tDCS well, with the active tDCS group reporting fewer strong symptoms compared to the sham group, suggesting it could be a feasible adjunct to behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on cognitive performance in youth with persistent cognitive symptoms following concussion: a controlled pilot study. Quinn de Launay, K., Cheung, ST., Riggs, L., et al.[2022]

Live Z-Score Training (LZT), a type of neurofeedback therapy, shows promise in reducing symptoms in patients with persistent post-concussive symptoms (PPCS) by modulating EEG activity without targeting specific brain regions.

Changes in EEG metrics, particularly the theta/alpha ratio and beta-related power, were linked to improvements in pain intensity, cognitive symptoms, and affective symptoms, suggesting that LZT can be tailored for more precise treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory Analysis. Hershaw, JN., Hill-Pearson, CA.[2022]

A personalized rTMS (PrTMS) protocol was tested on 185 patients with persistent concussion symptoms over approximately 6 weeks, showing improvements in concussion-related indices and normalization of EEG measures, suggesting potential changes in neurotransmitter and cognitive function.

While the results are promising, indicating that PrTMS may be a viable treatment option for concussion, the study lacked a control group and did not account for several variables, highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Observations of Personalized Repetitive Magnetic Stimulation (PrTMS) Guided by EEG Spectra for Concussion. Makale, MT., Nybo, C., Keifer, J., et al.[2023]

EEG biofeedback shows promising potential in improving attention and cognitive scores in individuals with reading disabilities and traumatic brain injury (TBI), suggesting it could be an effective intervention for these conditions.

The article advocates for further research into EEG biofeedback, emphasizing its clinical use under informed consent due to the lack of effective alternatives for treating reading disabilities and TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalogram biofeedback for reading disability and traumatic brain injury. Thornton, KE., Carmody, DP.[2009]

In a study of 59 patients with persistent postconcussion symptoms (PPCS), those who received infralow frequency neuromodulation (ILF) combined with a concussion protocol showed significantly greater improvements in symptoms compared to those receiving standard treatment alone.

The most common persistent symptoms included headaches, memory impairment, and brain fog, indicating that ILF therapy may be an effective integrative approach for managing these debilitating effects of traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Novel Concussion Protocol With Infralow Frequency Neuromodulation Demonstrates Significant Treatment Response in Patients With Persistent Postconcussion Symptoms, a Retrospective Study. Legarda, SB., Lahti, CE., McDermott, D., et al.[2023]

Neurofeedback (NF) has been explored as a treatment for various child psychiatric disorders, including ADHD, autism, learning disorders, and epilepsy, by providing real-time feedback on brain activity.

However, many studies on NF have methodological limitations, such as not using proper blinding or sham controls, and while clinical experience suggests NF is reasonably safe, its safety has not been rigorously studied in youth or adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. Hurt, E., Arnold, LE., Lofthouse, N.[2019]

Citations

1. withpower.com withpower.com/trial/phase-brain-injuries-11-2023-87bf9

Neurofeedback for Concussion-Related Light Sensitivity Trial Overview The study tests a Micro Current Neurofeedback Device using low-frequency electrical stimulation to see if it helps reduce light sensitivity in ...

2. ctv.veeva.com ctv.veeva.com/study/pilot-study-of-neurofeedback-for-photosensitivity-in-mild-traumatic-brain-injury

Pilot Study of Neurofeedback for Photosensitivity in Mild ... The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836789/

The effectiveness of microcurrent neurofeedback on ... The purpose of this pilot study was to explore the effects of microcurrent neurofeedback on depression, anxiety, PTSD symptoms, and QOL in adults.

4. microcurrentneurofeedback.com microcurrentneurofeedback.com/transcranial-stimulation-mtbi/

Transcranial Stimulation for mTBI | IASIS Technologies This fascinating transcranial stimulation study explores the effects of Concussion, TBI & PTSD & the benefits of Micro Current Neurofeedback.

5. researchgate.net researchgate.net/publication/342322297_Transcranial_low-frequency_pulsating_electromagnetic_fields_T-PEMF_as_post-concussion_syndrome_treatment

Transcranial low‐frequency pulsating electromagnetic ... The majority (n=5) had a reduction in symptoms overall, up to 61% [2‐61%] based on the Rivermead Post‐Concussion Symptoms Questionnaire. Conclusion Further ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03244475

NCT03244475 | Transcranial Electrical Stimulation for mTBI IASIS is among a class of passive neurofeedback treatments that combine low-intensity pulses for transcranial electrical stimulation (LIP-tES) with ...