Light Box Therapy for Traumatic Brain Injury

Overseen By Miranda Lim, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Portland VA Medical Center

Disqualifiers: Decisional impairment, Macular degeneration, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how morning bright light therapy, using a special light box, affects sleep in Veterans with traumatic brain injury (TBI). Researchers aim to determine if this therapy can improve sleep quality and enhance cognition, mood, and overall quality of life. They also seek to identify any blood markers linked to sleep improvements. Veterans who speak English and can be reached by phone may qualify, provided they do not have conditions like macular degeneration or bipolar disorder. The study is fully remote, with participants using a light box or a negative ion generator (a device that releases negatively charged ions) for an hour each morning over four weeks. As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could improve sleep and quality of life for others with TBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that light box therapy is safe for Veterans with traumatic brain injury?

Research has shown that light box therapy is generally safe and effective for improving sleep and reducing tiredness, particularly in individuals with brain injuries. In one study, about 75% of participants reported a positive experience with the therapy. Adherence to the therapy was high, with participation rates between 87% and 97%. Another study found that light therapy reduced tiredness and sleepiness following a brain injury.

These studies suggest that light box therapy is safe, especially since it is readily available for purchase. The therapy typically involves sitting near a lightbox that emits bright light, which can help regulate sleep patterns. So far, there have been no significant reports of serious side effects, making it a promising option for those seeking to improve sleep quality. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Light box therapy is unique because it uses bright light exposure to potentially improve symptoms of traumatic brain injury (TBI), a novel approach compared to standard treatments like medication and rehabilitation therapies. Unlike traditional methods that focus on physical and cognitive rehabilitation, light box therapy targets the brain's biological clock to enhance mood, sleep, and cognitive function by resetting circadian rhythms. Researchers are excited about this treatment because it offers a non-invasive, drug-free option that could complement existing therapies and provide quicker symptom relief. The use of a negative ion generator as a sham comparator also helps in assessing the specific efficacy of light exposure, differentiating its effects from placebo.

What evidence suggests that this trial's treatments could be effective for improving sleep in Veterans with traumatic brain injury?

Research has shown that morning bright light therapy (MBLT), one of the treatments in this trial, may improve sleep for Veterans with traumatic brain injury (TBI). Studies have found MBLT practical and potentially effective for treating sleep problems in this group. About 75% of participants provided positive feedback on the therapy, and most used the lightbox regularly. Additionally, MBLT might help reduce other TBI symptoms, such as tiredness and mood issues. Overall, these findings suggest that light therapy could improve sleep and possibly enhance the quality of life for those with TBI. Another treatment arm in this trial uses a negative ion generator as a sham comparator. ^{1 2 3 6 7}

Who Is on the Research Team?

Miranda Lim, MD, PhD

Principal Investigator

Portland VA

Are You a Good Fit for This Trial?

This trial is for Veterans who have experienced a traumatic brain injury. Participants must speak English and be reachable by phone. It's not suitable for those with decision-making impairments, bipolar disorder, current users of lightbox or negative ion generators, macular degeneration, or those doing shift work.

Inclusion Criteria

English-speaking

Veteran

I can be reached by phone.

Exclusion Criteria

I have macular degeneration.

You are currently using a lightbox or negative ion generator.

I have difficulty making decisions due to a mental condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive morning bright light therapy (MBLT) or a sham comparator for 4 weeks

4 weeks

Remote or in-person sessions daily

Follow-up

Participants are monitored for changes in insomnia severity and biomarkers after treatment

8 weeks

Remote assessments at 2 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Light box therapy
• Negative Ion Generator

Trial Overview The study tests if morning bright light therapy (MBLT) can improve sleep quality in Veterans with TBI. It also explores how MBLT affects cognition, mood, life quality and examines blood markers to predict response to the treatment. The entire study can be done remotely.

How Is the Trial Designed?

Group I: Light box Experimental Treatment 1 Intervention

Commercially available lightbox emitting 10,000 lux of light. Subjects asked to use lightbox everyday for an hour for 4 weeks upon waking.

Group II: Negative Ion Generator Placebo Group 1 Intervention

Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.

Light box therapy is already approved in United States, European Union for the following indications:

Approved in United States as Bright Light Therapy for:

• Seasonal affective disorder
• Non-seasonal depression
• Sleep disorders
• Circadian rhythm disorders

Approved in European Union as Light Box Therapy for:

• Seasonal affective disorder
• Sleep disorders
• Circadian rhythm disorders

Who Is Running the Clinical Trial?

Portland VA Medical Center

Lead Sponsor

Trials

44

Recruited

7,800+

Center for Neuroscience and Regenerative Medicine (CNRM)

Collaborator

Trials

24

Recruited

5,000+

Published Research Related to This Trial

In a study involving 24 individuals with traumatic brain injury or stroke, light therapy showed potential benefits in improving sleep quality, particularly for younger participants and those with an evening chronotype.

While no demographic or clinical variables significantly affected fatigue outcomes, the type of injury influenced reaction times, with stroke patients experiencing greater improvements than those with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Pilot Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury and Stroke. Connolly, LJ., Rajaratnam, SMW., Spitz, G., et al.[2021]

Blue-wavelength light therapy (BWLT) significantly reduces sleep disturbances and depressive symptoms in individuals with traumatic brain injury (TBI), based on a meta-analysis of six trials involving 278 participants.

BWLT shows promising trends in reducing sleepiness and fatigue, indicating it may be a beneficial treatment option for various behavioral symptoms following TBI, with no significant difference in dropout rates between treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of blue-wavelength light therapy for post-TBI behavioral symptoms: A systematic review and meta-analysis of randomized controlled trials. Srisurapanont, K., Samakarn, Y., Kamklong, B., et al.[2022]

In a study of 35 adults aged 18 to 45 with mild traumatic brain injury, daily 30-minute sessions of blue light therapy for 6 weeks significantly improved sleep quality and reduced daytime sleepiness compared to placebo amber light therapy.

Participants receiving blue light therapy also reported lower levels of depression and post-concussion symptoms, suggesting that this nonpharmacological treatment could effectively address multiple issues related to sleep disruption after a mild traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury. Raikes, AC., Dailey, NS., Shane, BR., et al.[2021]

In a study involving 12 military Veterans with chronic traumatic brain injury (TBI), pulsed transcranial photobiomodulation therapy (PBMT) using LEDs significantly improved neuropsychological scores in 40% of the assessed areas, indicating potential cognitive benefits.

SPECT imaging revealed increased regional cerebral blood flow (rCBF) in 66.7% of participants, suggesting that LED therapy may enhance brain function years after injury, although further research with larger sample sizes is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Transcranial Red/Near-Infrared Light Therapy Using Light-Emitting Diodes Improves Cerebral Blood Flow and Cognitive Function in Veterans with Chronic Traumatic Brain Injury: A Case Series. Hipskind, SG., Grover, FL., Fort, TR., et al.[2020]

In a study of 24 female patients aged 15-20 with anorexia nervosa and depressive symptoms, those receiving bright light therapy (BLT) showed significantly greater improvement in depression symptoms after 5 and 6 weeks compared to those who only received cognitive behavioral therapy.

While both groups experienced similar increases in body mass index (BMI) after 6 weeks, the BLT group began to see improvements in BMI earlier, suggesting that BLT may enhance overall treatment effectiveness for depression in anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light treatment of depressive symptoms in patients with restrictive type of anorexia nervosa. Janas-Kozik, M., Krzystanek, M., Stachowicz, M., et al.[2018]

In two case studies involving individuals with traumatic brain injury (TBI), an 8-week personalized in-home light therapy significantly reduced fatigue, sleep disturbance, and insomnia symptoms, demonstrating its potential efficacy as a treatment.

Participants reported high compliance (over 70%) and found the light therapy feasible and well-tolerated, with no serious side effects, indicating it could be a safe and acceptable intervention for improving quality of life after brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. Connolly, LJ., Ponsford, JL., Rajaratnam, SMW., et al.[2021]

Transcranial photobiomodulation (tPBM) using red and near-infrared LEDs has shown significant improvements in cognitive function and reduced PTSD symptoms in chronic traumatic brain injury (TBI) patients, based on a study of 11 patients who received 18 treatments over 6 weeks.

The LED therapy is noninvasive and painless, and ongoing studies are exploring its effects on sleep and cognitive function in TBI patients, with promising results indicating increased sleep duration and continued cognitive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Naeser, MA., Martin, PI., Ho, MD., et al.[2017]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

In a pilot study involving 30 hospitalized cystic fibrosis patients, daily bright-light therapy significantly reduced depressive symptoms and improved quality of life, with 80% of subjects showing at least mild depressive symptoms upon admission.

Patients receiving light therapy had a shorter average hospital stay of 11.0 days compared to a historical cohort's 13.3 days, indicating that light therapy may enhance recovery during hospitalization without any reported adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of light therapy for depression in hospitalized patients with cystic fibrosis. Kopp, BT., Hayes, D., Ghera, P., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35421086/

Feasibility and preliminary efficacy for morning bright light ... Morning bright light therapy is a feasible and acceptable intervention that shows preliminary efficacy to treat disrupted sleep in Veterans with TBI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9009710/

Feasibility and preliminary efficacy for morning bright light ... The protocol was rated favorably by ~75% of participants, with adherence to the lightbox and actigraphy being ~87% and 97%, respectively. Post- ...

3. reviewofoptometry.com reviewofoptometry.com/article/morning-bright-light-therapy-may-reduce-tbi-symptoms

Morning Bright Light Therapy May Reduce TBI Symptoms This study found that light box treatment may reduce symptoms of traumatic brain injury.

4. clinicaltrials.gov clinicaltrials.gov/show/NCT03785600

NCT03785600 | Improving Sleep in Veterans With TBI The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be cost-effective, rapidly deployable, and ...

5. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-021-02292-8

Home-based light therapy for fatigue following acquired brain ... This study evaluated the efficacy of a novel in-home light intervention in alleviating fatigue, sleep disturbance, daytime sleepiness and depressive symptoms.

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0274025

Efficacy and acceptability of blue-wavelength light therapy for ... Most trials delivered light therapy via lightboxes. Three trials had a high risk of bias. BWLT was significantly superior to LW/NLT in reducing ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.651498/full

Development of a Home-Based Light Therapy for Fatigue ... The findings of this study suggested that blue light therapy was effective in alleviating fatigue and daytime sleepiness following TBI (16).