Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients
Study Details
Study Description
Brief Summary
The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Concussion or mild traumatic brain injury (mTBI) is an acute neurophysiological event related to blunt impact applied to the head and/or neck due to sudden acceleration, deceleration or rotational forces. It can happen due to motor vehicle accidents, sport or recreational injury, falls, workplace injury or assault. mTBI can be differentiated from moderate and severe traumatic brain injuries by having negative imaging or laboratory results and a Glasgow Coma Scale (GCS) score of 13-15. Current treatment modalities for the various symptoms associated with mTBI are mostly supportive: pain medication, antidepressants, psychotherapy, physiotherapy, vision therapy and referral to sleep clinics.
mTBI symptoms are usually divided into four groups: cognitive symptoms, physical symptoms, emotional symptoms and sleep symptoms. Although most of these symptoms resolve or improve with or without treatment within 3 months following injury there is a significant population of post-mTBI patients who continue to suffer from symptoms 3 months to years after their injury. Previously called Post-Concussive Syndrome (PCS) most groups now classify PCS as a neurological disorder with persistent post-concussive symptoms. Insufficient and disturbed sleep are reported by half of all patients and are among the most common complaints following mTBI, and can develop during the early to chronic post-mTBI phases. Various sleep abnormalities, including post-TBI insomnia, hypersomnia, and sleep apnea are frequently observed. Most cases of sleep symptoms associated with mTBI that are diagnosed during sleep studies tend to be apnea related, although the cause of this is still unknown. Sleep apnea can be obstructive or central sleep apnea, but both types tend to respond well to Continuous Positive Airway Pressure. For other types of non-apneic sleep related symptoms post mTBI though, treatment can vary from Cognitive Behavioural Therapy (CBT) to various sleep medications. However, it is noted that despite an improvement in objective sleep symptoms with conventional approaches to patients with mTBI, there continues to be a lack of improvement in terms of subjective sleepiness or neuropsychological functions.
Photobiomodulation therapy (PBMT) is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders, including concussions. Noted among the effects of PBMT among post-mTBI patients in the clinical setting is a subjective improvement in sleep, sometimes described by patients as "the best sleep they've ever had." The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Post-Concussion Patients with Non-Apneic Sleep Disorder Patients will be treated with PBMT using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries. |
Device: Photobiomodulation Therapy
PBMT will be applied to the cervical spine using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Statistically significant changes in the Pittsburgh Sleep Quality Index (PSQI) scores from baseline and at 4 weeks [Baseline, 4 weeks]
The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
- Statistically significant changes in the Pittsburgh Sleep Quality Index (PSQI) scores from baseline and at 8 weeks [Baseline, 8 weeks]
The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
- Statistically significant changes in the Pittsburgh Sleep Quality Index (PSQI) scores from baseline and at 12 weeks [Baseline, 12 weeks]
The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Secondary Outcome Measures
- Statistically significant changes in the Functional Outcomes of Sleep Questionnaire (short version) (FOSQ-10) scores from baseline [Baseline, 4 weeks, 8 weeks, 12 weeks]
The short 10-item version of the original 30 item FOSQ using selected items from each subscale and providing the same definition of sleepy and tired. Items for the FOSQ-10 are distributed among the same subscales as follows: 1) activity level (3 items), 2) vigilance (3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item).
- Statistically significant changes in the Multidimensional Fatigue Inventory (MFI) scores from baseline [Baseline, 4 weeks, 8 weeks, 12 weeks]
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Respondents use a scale ranging from 1 to 7 to indicate how aptly certain statements regarding fatigue represent their experiences. Several positively phrased items are reverse scored. Higher total scores correspond with more acute levels of fatigue.
- Statistically significant changes in the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) scores from baseline [Baseline, 4 weeks, 8 weeks, 12 weeks]
RPQ is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI). It is a 16-item self-report questionnaire that assesses the severity of 16 different PCS symptoms that typically follow TBI. Patients are asked to rate their symptoms before and after their injury and also to rate the severity of their symptoms in the last 24 h. Items follow a 5-point ordinal rating system where 0 = never experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. Thus total scores using the sum of all items can theoretically range from 0 to 64.
Other Outcome Measures
- Any potential changes in Stage 3 Non Rapid Eye Movement (NREM) or N3 sleep duration (time in minutes) during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks. [Baseline, 8 weeks]
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to examine and assess each sleep stage for breathing and movement during sleep.
- Any potential changes in Stage 4 Rapid Eye Movement (REM) sleep duration (time in minutes) during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks [Baseline, 8 weeks]
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to examine and assess each sleep stage for breathing and movement during sleep.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients between the ages of 18-45 years clinically diagnosed with a Mild Traumatic Brain Injury (mTBI) diagnosed between 3 to 24 months from presentation complaining of sleep disturbance.
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Underwent a sleep study PSG.
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Documentation of a history of a qualifying mTBI within 3 to 24 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria for Post Concussive Syndrome (PCS) require a history of mTBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and
- intolerance of stress, emotion, or alcohol.
Exclusion Criteria:
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Any positive cranial findings on imaging studies
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A diagnosis of or a family history of neuropsychiatric co-morbidity.
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Any additional diagnoses compounding the diagnosis of a mTBI.
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Currently undergoing Cognitive Behavioural Therapy.
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Currently taking any medication for the purpose of improving sleep including medical and recreational cannabis, barbiturates, benzodiazepines, antidepressants, antihistamines, melatonin or other natural supplements.
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Diagnosed with sleep apnea (obstructive or central) by polysomnography or requiring Continuous Positive Airway Pressure (CPAP) to relieve sleep apnea.
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Currently undergoing any alternative or complementary medical procedure, i.e. acupuncture, hypnosis, homeopathy, etc.
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Pregnancy
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Malignant growth in the neck and cranium
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Taking any photosensitizing medication.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Meditech Rehabilitation Centre | Toronto | Ontario | Canada | M8W 4W3 |
Sponsors and Collaborators
- Michael Zitney
- Meditech Rehabilitation Centre
Investigators
- Principal Investigator: Michael Zitney, MD, Meditech International
Study Documents (Full-Text)
None provided.More Information
Publications
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213.
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- Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9.
- King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92.
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- Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203. Erratum in: JAMA. 2016 Jun 21;315(23):2624.
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