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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this project is to determine the effect of morning bright light therapy (MBLT) on sleep in Veterans with traumatic brain injury (TBI). Secondarily, the project aims to identify blood-based brain biomarkers (BBBM) associated with sleep in Veterans. Specific Aim 1. Determine the effect of MBLT on sleep quality in Veterans (primary outcome). Specific Aim 2. Determine the effect of MBLT on downstream effectors of improved sleep, including cognition, mood, and quality of life measures in Veterans (exploratory outcomes). Specific Aim 3. Determine the effect of MBLT on levels of specific BBBM related to sleep, and whether changes in specific BBBM predict response to MBLT (secondary outcome). This study can now be completed 100% remotely.

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 data supports the effectiveness of light box therapy for traumatic brain injury?

Research suggests that light therapy can help improve sleep quality and reduce fatigue in individuals with traumatic brain injury. Additionally, studies have shown that light therapy can improve depressive symptoms and cognitive function in other conditions, indicating its potential benefits for brain injury recovery. ^{1 2 3 4 5}

Is light box therapy safe for humans?

Research on light box therapy, including studies on traumatic brain injury and seasonal depression, indicates it is generally safe for humans. Participants in these studies reported no serious side effects, with some experiencing minor issues like blurring, but no headaches were noted. ^{1 3 6 7 8}

How does light box therapy differ from other treatments for traumatic brain injury?

Light box therapy is unique because it uses bright light exposure to help reduce fatigue and improve sleep quality in people with traumatic brain injury. Unlike other treatments, it is non-invasive and can be administered at home, making it a convenient option for managing symptoms like sleep disturbances and fatigue. ^{1 3 5 6 9}

Research Team

Miranda Lim, MD, PhD

Principal Investigator

Portland VA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Pilot Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury and Stroke. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Bright light treatment of depressive symptoms in patients with restrictive type of anorexia nervosa. [2018]

3. United States 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. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot trial of light therapy for depression in hospitalized patients with cystic fibrosis. [2018]

5. United States 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. [2017]