exercise as concussion therapy trial- 2

Conditions: Mild Traumatic Brain Injury; Concussion, Mild

Summary: this study is a phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mtbi. subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design. the effects of graded exercise and passive stretching will be compared using clearplay© (answers neuroscience pty ltd commercial mobile application) the study will also validate the performance of two devices: 1. clearheart©, answers neuroscience pty ltd commercial prototype for cold pressor testing, compared to ice bucket testing. 2. clearplay©, answers neuroscience pty ltd commercial prototype based on the joint position error test to assess "whiplash".

study type: interventional estimated enrollment: 400 participants allocation: randomized intervention model: parallel assignment masking: none (open label) primary purpose: treatment official title: a therapeutic intervention, open-label study to compare the efficacy and safety of graded exercise compared to passive stretching in subjects who have sustained a mild traumatic brain injury estimated study start date: october 1, 2020 estimated primary completion date: september 30, 2022 estimated study completion date: september 30, 2023

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥14 to ≤45, able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor subjects, with the minor providing age appropriate assent, according to local law and regulations; 2. subject is fluent in english, able to understand and agree to comply with protocol requirements, and complete all assessments; 3. subject has a history of recent concussion as diagnosed by a health care professional within 3 to 14 days of enrolment; note: concussion is defined as a head injury/blow to the head resulting in any of the following 3 signs and/or new symptoms: (1) amnesia for less than 24 hours; (2) loss of consciousness for less than 30 minutes; (3) glasgow coma scale score \> = 13; (4) dazed and confused/bell rung; with at least 1 new symptom or augmentation of a previous symptom on the pcss as compared with baseline at the time of enrolment, including: headaches, dizziness, fatigue, irritability, insomnia, difficulty concentrating, and/or memory difficulties; (5) the composite symptom score on the pcss must be at least 3 points higher post-concussion than pre-concussion. 4. subject has daily access to the internet. exclusion criteria: 1. history of prior head injury as defined by: 1. an injury/blow to the head within 12 months prior to screening with any associated residual symptoms; 2. an injury/blow to the head within 3 months prior to screening diagnosed as a concussion; 3. an injury/blow to the head within 3 months prior to screening with any of the following symptoms: amnesia, loss of consciousness, dazed and confused/bell rung; 2. evidence of blood or micro-hemorrhages on prior or current computed tomography scan or magnetic resonance imaging scan if obtained; 3. diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus; 4. psychiatric history with any of the following: 1. history of psychiatric hospitalization, history of legal trouble for violence; 2. requires psychotropic medication other than (1) stable dose of a selective serotonin reuptake inhibitors (ssri) medication, or (2) stable dose of a tricyclic antidepressants (tca) medication; 3. prior diagnosis of psychotic disorder, bipolar disorder, eating disorder, substance abuse disorder; 5. current use of a beta blocker; 6. history of drug or alcohol dependency or abuse within a year before screening, by self-report; 7. two or more the following cardiovascular risk factors: 1. prior diagnosis of, or currently taking medication for cardiovascular, metabolic or pulmonary conditions; 2. family history of myocardial infarction, coronary revascularization or sudden death before 55 years; 3. diagnosis of hypertension; 4. diagnosis of hyperlipidemia; 5. subjects with peripheral circulatory disorders; 8. subjects who are unable or unwilling to exercise for health or personal reasons; 9. subjects who have musculoskeletal injuries which could make exercise difficult or painful.

Keywords: concussion mild traumatic brain injury (mtbi) exercise therapy telemedicine therapeutic intervention autonomic function medical device