Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients
Post-Concussion Syndrome, Sleep Disorder
About this trial
This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Post-Concussion Syndrome, Photobiomodulation, Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
- Underwent a sleep study PSG.
- 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 8) intolerance of stress, emotion, or alcohol.
Exclusion Criteria:
- Any positive cranial findings on imaging studies
- A diagnosis of or a family history of neuropsychiatric co-morbidity.
- Any additional diagnoses compounding the diagnosis of a mTBI.
- Currently undergoing Cognitive Behavioural Therapy.
- Currently taking any medication for the purpose of improving sleep including medical and recreational cannabis, barbiturates, benzodiazepines, antidepressants, antihistamines, melatonin or other natural supplements.
- Diagnosed with sleep apnea (obstructive or central) by polysomnography or requiring Continuous Positive Airway Pressure (CPAP) to relieve sleep apnea.
- Currently undergoing any alternative or complementary medical procedure, i.e. acupuncture, hypnosis, homeopathy, etc.
- Pregnancy
- Malignant growth in the neck and cranium
- Taking any photosensitizing medication.
Sites / Locations
- Meditech Rehabilitation CentreRecruiting
Arms of the Study
Arm 1
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.