A randomized, double-blind, placebo-controlled trial of blue wavelength light exposure on sleep and recovery of brain structure, function, and cognition following mild traumatic brain injury

Abstract Background Mild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated. Objective To compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week). Methods In this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used. Discussion Controlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations. Trial registration ClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

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1171 SHORT-WAVELENGTH LIGHT THERAPY AS A WAY OF IMPROVING SLEEP, COGNITION, AND FUNCTIONAL CONNECTIVITY FOLLOWING A MILD TRAUMATIC BRAIN INJURY

SLEEP ◽

10.1093/sleepj/zsx050.1170 ◽

2017 ◽

Vol 40 (suppl_1) ◽

pp. A437-A437

Author(s):

JR Vanuk ◽

BR Shane ◽

S Bajaj ◽

M Millan ◽

M Grandner ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Functional Connectivity ◽

Mild Traumatic Brain Injury ◽

Short Wavelength ◽

Light Therapy ◽

Short Wavelength Light ◽

Wavelength Light

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Blue-wavelength light therapy for post-traumatic brain injury sleepiness, sleep disturbance, depression, and fatigue: A systematic review and network meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0246172 ◽

2021 ◽

Vol 16 (2) ◽

pp. e0246172

Author(s):

Karan Srisurapanont ◽

Yanisa Samakarn ◽

Boonyasit Kamklong ◽

Phichayakan Siratrairat ◽

Arina Bumiputra ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Sleep Disturbance ◽

Meta Analysis ◽

Light Therapy ◽

Blue Wavelength ◽

History Of ◽

Post Traumatic ◽

Wavelength Light ◽

Quality Evidence

Objective This review aimed to determine the efficacy of blue-wavelength light therapy (BWLT) for post-traumatic brain injury (TBI) sleepiness, sleep disturbance, depression, and fatigue. Methods Pubmed, Scopus, Web of Science, Cochrane Library, Academic Search Complete, and CINAHL. Included trials were randomized controlled trials (RCTs) of BWLT in adults with a history of TBI. Outcomes of interest included sleepiness, sleep disturbance, depression, or fatigue. Two reviewers independently screened the searched items, selected the trials, extracted the data, and rating the quality of trials. We aggregated the data using a random-effect, frequentist network meta-analysis (NMA). Results We searched the databases on July 4, 2020. This review included four RCTs of 117 patients with a history of TBI who were randomized to received BWLT, amber light therapy (ALT), or no light therapy (NLT). Moderate-quality evidence revealed that: i) BWLT was significantly superior to NLT in reducing depression (SMD = 0.81, 95% CI = 0.20 to 1.43) ii) BWLT reduced fatigue at a significantly greater extent than NLT (SMD = 1.09, 95% CI = 0.41 to 1.76) and ALT (SMD = 1.00, 95% CI = 0.14 to 1.86). Low-quality evidence suggested that BWLT reduced depression at a greater extent than ALT (SMD = 0.57, 95% CI = 0.04 to 1.10). Low-quality evidence found that the dropout rates of those receiving BWLT and ALT were not significantly different (RR = 3.72, 95% CI = 0.65 to 21.34). Conclusion Moderate-quality evidence suggests that BWLT may be useful for post-TBI depression and fatigue.

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Early Survival of Comatose Patients after Severe Traumatic Brain Injury with the Dual Cannabinoid CB1/CB2 Receptor Agonist KN38-7271: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial

Journal of Neurological Surgery Part A Central European Neurosurgery ◽

10.1055/s-0032-1304815 ◽

2012 ◽

Vol 73 (04) ◽

pp. 204-216 ◽

Cited By ~ 7

Author(s):

Raimund Firsching ◽

Jürgen Piek ◽

Martin Skalej ◽

Veit Rohde ◽

Uwe Schmidt ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Phase Ii ◽

Severe Traumatic Brain Injury ◽

Receptor Agonist ◽

Phase Ii Trial ◽

Cb2 Receptor ◽

Double Blind ◽

Double Blind Placebo ◽

Early Survival

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When Basic Research Doesn't Translate to the Bedside—Lessons from the Magnesium Brain Trauma Study

Epilepsy Currents ◽

10.1111/j.1535-7511.2007.00201.x ◽

2007 ◽

Vol 7 (5) ◽

pp. 133-135 ◽

Cited By ~ 2

Author(s):

John W. Miller ◽

Raimondo D'Ambrosio

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Severe Traumatic Brain Injury ◽

Primary Outcome ◽

Brain Injuries ◽

Controlled Trial ◽

Serum Magnesium ◽

Trauma Centre ◽

Double Blind ◽

Positive Effect

Magnesium Sulfate for Neuroprotection After Traumatic Brain Injury: A Randomised Controlled Trial. Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J, Lucas T, Newell DW, Mansfield PN, Machamer JE, Barber J, Dikmen SS. Lancet Neurol 2007;6(1):29–38. BACKGROUND: Traumatic brain injuries represent an important and costly health problem. Supplemental magnesium positively affects many of the processes involved in secondary injury after traumatic brain injury and consistently improves outcome in animal models. We aimed to test whether treatment with magnesium favourably affects outcome in head-injured patients. METHODS: In a double-blind trial, 499 patients aged 14 years or older admitted to a level 1 regional trauma centre between August, 1998, and October, 2004, with moderate or severe traumatic brain injury were randomly assigned one of two doses of magnesium or placebo within 8 h of injury and continuing for 5 days. Magnesium doses were targeted to achieve serum magnesium ranges of 1 0–1·85 mmol/L or 1·25–2·5 mmol/L. The primary outcome was a composite of mortality, seizures, functional measures, and neuropsychological tests assessed up to 6 months after injury. Analyses were done according to the intention-to-treat principle. This trial is registered with Clinicaltrials.gov, number NCT00004730. FINDINGS: Magnesium showed no significant positive effect on the composite primary outcome measure at the higher dose (mean = 55 average percentile ranking on magnesium vs. 52 on placebo, 95% CI for difference – 7 to 14; p = 0·70). Those randomly assigned magnesium at the lower dose did significantly worse than those assigned placebo (48 vs. 54, 95% CI −10·5 to −2; p = 0007). Furthermore, there was higher mortality with the higher magnesium dose than with placebo. Other major medical complications were similar between groups, except for a slight excess of pulmonary oedema and respiratory failure in the lower magnesium target group. No subgroups were identified in which magnesium had a significantly positive effect. INTERPRETATION: Continuous infusions of magnesium for 5 days given to patients within 8 h of moderate or severe traumatic brain injury were not neuroprotective and might even have a negative effect in the treatment of significant head injury.

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