Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
Primary Purpose
Brain Concussion, Post-Concussion Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
London Health Sciences Centre - Compression Vest
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Brain Concussion
Eligibility Criteria
Inclusion Criteria:
- concussed: medically diagnosed with, and being treated for a concussion for no longer than 1 year
- healthy volunteer: no previous medical diagnosis of a concussion
Exclusion Criteria:
- bone or muscle problems that could impact balance or how well you walk
- diagnosis of pre-existing heart disease
- medications that affect heart or blood vessel control
- pre-existing brain disorders such as Parkinson's, Multiple Sclerosis, Raynaud's, Multiple System Atrophy, metabolic disorders such as diabetes, a history of significant neck injury, or focal neurologic deficit
- primary or metastatic bone tumour
- severe osteoporosis
- if you are, or think you might be, pregnant or breastfeeding
- if you are not able to be understand English
Sites / Locations
- Fowler Kennedy Sports Medicine Clinic
- Neurovascular Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
Experimental
Arm Label
Usual care + exercise
No care, no exercise
Usual care + exercise + compression vest
Arm Description
Usual care + exercise
No care, no exercise
Usual care + exercise + London Health Sciences Centre - Compression Vest
Outcomes
Primary Outcome Measures
Change in symptom profile
Timeline to asymptomatic and clinical discharge
Change in exercise tolerance
Duration and wattage achieved at symptom exacerbation
Secondary Outcome Measures
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7) scale
Balance
Change in Stability Index, quantified via BioDex Technology
Transcranial Doppler Ultrasound - Cerebrovascular Function
Change in middle cerebral artery blood velocity - cm/s
Heart Rate Variability
Measure of autonomic function - quantified via R-R interval duration (seconds)
Baroreflex Sensitivity
Measure of autonomic function - quantified via changes in blood pressure for a given heart rate
Cognitive Function
Cogingram - assessment of psychomotor function, attention, learning and working memory
Full Information
NCT ID
NCT02362347
First Posted
February 5, 2015
Last Updated
March 5, 2019
Sponsor
Western University, Canada
Collaborators
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02362347
Brief Title
Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
Official Title
Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this investigation is to determine the effect of a weighted compression vest in addition to usual medical care and exercise rehabilitation on cardiovascular, neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and being treated for, a mild traumatic brain injury.
Detailed Description
Mild traumatic brain injury (mTBI), or concussion, induces significant impairment to a patient's mobility and tolerance for daily living activities with symptoms that include decreased balance, dizziness, confusion, headaches, visual and auditory sensitivities. If recognized promptly, many of these injuries respond well to immediate rest and standard rehabilitation strategies. However, approximately 10-30% of these patients will experience persistent symptoms beyond the ~2 week period of spontaneous healing. The persistent symptoms point to neural damage, or disrupted neural networks in the brain, but the actual mechanism or nature of neural damage remains to be elucidated. The brain's neural activity must be supported by rapid adjustments to, and optimal distribution of, blood flow. However, cerebrovascular control remains poorly studied in the context of persistent concussion symptoms, particularly the reactivity element of flow control such as how fast it recovers during drops in blood pressure such as when one stands up from the sitting posture. Cerebrovascular damage in mTBI appears to affect mostly the autoregulatory adjustments to changes in brain perfusion pressure (i.e., from lying down to standing up) (Len et al., 2013;Junger et al., 1997). The investigators will study the impact of mTBI in both acute and persistent stages on cerebrovascular adjustments to metabolic and pressure-dependent stimuli. Currently, decisions regarding rate and completeness of healing remain subjective which can lead to earlier-than-optimal return of the patient to inappropriate levels of activity, work or school. Improved and cost-effective markers of the rate and completeness of brain healing are needed that can be obtained in the clinic. One challenge might be the emphasis in previous investigations on searching for a single biomarker of damage in a highly integrated system. Rather, the investigators believe it may be more effective to employ a holistic perspective; focusing on a comprehensive neural outcome might provide enhanced insight into the severity of damage and rate or completion of recovery. Previously, several investigators established heart rate variability (HRV) as sensitive marker of abnormal brain function in TBI (traumatic brain injury) cases for both adults and children (Goldstein et al., 1998;Goldstein et al., 1996). Moreover, these studies imply that autonomic nervous system control of heart rate is disrupted in proportion to the degree of neurologic insult. Thus, heart rate power spectral analysis may prove to be a useful adjunct in determining severity of neurologic injury and prognosis for recovery. Despite many studies outlining the relationship between mTBI and HRV (Ryan et al., 2011;Goldstein et al., 1998;Goldstein et al., 1996;Papaioannou et al., 2008;La Fountaine et al., 2009) no follow-up research has been conducted to establish this method (which is cost-effective, non-invasive, comprehensive and easily-obtained) as a routine assessment of TBI severity, or rehabilitative efficacy. An additional neural network associated with cardiac function is the baroreflex and the sensitivity of this neural network (baroreflex sensitivity; BRS) can be studied with non-invasive measures of heart rate and blood pressure. In the past and currently our lab has used both methods of HRV and BRS safely and effectively (Zamir et al., 2013;Kiviniemi et al., 2010;Kiviniemi et al., 2011;Shoemaker et al., 2012). This current study will assess the feasibility and impact of routine measurements of cardiac dynamics as a sensitive marker of the severity and persistence of "overall" brain damage in mTBI patients. Based on more than 30 failed clinical trials, no single pharmacological agent can be prescribed to minimize TBI-induced brain damage, despite efficacy shown for several agents in rodent studies (see (Kabadi & Faden, 2014) for review). In contrast, non-pharmacological approaches in rodents, show that both pathophysiological changes and neurological impairment after experimental TBI can be attenuated by physical activity (Griesbach et al., 2004;Griesbach et al., 2009). Thus, there is value in considering application of "appropriate" exercise as soon as possible in mTBI patients, but not too soon because the value of exercise in rodent models were observed only when applied after the acute stage (Griesbach et al., 2007;Piao et al., 2013). Therefore, this study will also examine the impact of adding prescriptive exercise in addition to usual clinical care on the rate of concussion recovery. Enabling patients to receive the benefits of enhanced levels of physical activity during treatments for concussion may be limited by the concussion symptoms. Nonetheless, recent anecdotal evidence from our Parkwood group has illustrated the remarkable benefit to many patients with persistent symptoms provided by the wearing of a compression vest (HSREB #103325 and #104865). Briefly, the weighted compression vests (5% of the individual's body mass) are individualized and fitted to each subject to ensure its snug but does not impede one's respirations (similar to a bulletproof vest). The noted benefits of the compression vest include instant improvements to balance and gait, and reduced anxiety during stair climbing. Since this adaptive method of treatment appears to exert a powerful effect on enhancing patient's ability to perform exercise, and is consistent with the personalized medicine approach (like the exercise intervention), further investigation into the effect of the compression vest on concussion symptoms and rehabilitation is a viable area of research. To date the impact of compression vest interventions has yet to be examined in patients during the acute TBI phase or in younger individuals. Thus, the aim of the next phase of study is to establish whether interventions with a weighted compression vest can enhance exercise tolerance for patients in both acute and persistent phases of the TBI, with explorations into possible mechanistic links to cerebrovascular, cardiovascular and neural outcomes. If so, then new evidence supporting the use of compression vests could change clinical practice and, importantly, improve long-term health outcomes for many patients. In review, the purpose of this investigation is to determine the efficacy of novel methods of mild traumatic brain injury rehabilitation in addition to usual concussion rehabilitation programs. Concussed participants will complete a longitudinal study in which they will be randomly allocated to one of three rehabilitation groups: 1) usual care 2) usual care + exercise 3) usual care + exercise + compression vest. The efficacy of each rehabilitation group will be primarily quantified via changes in routine cardiac dynamic measurements (HRV, BRS, changes in blood flow with changes in posture).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Post-Concussion Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care + exercise
Arm Type
Active Comparator
Arm Description
Usual care + exercise
Arm Title
No care, no exercise
Arm Type
No Intervention
Arm Description
No care, no exercise
Arm Title
Usual care + exercise + compression vest
Arm Type
Experimental
Arm Description
Usual care + exercise + London Health Sciences Centre - Compression Vest
Intervention Type
Device
Intervention Name(s)
London Health Sciences Centre - Compression Vest
Intervention Description
London Health Sciences Centre - Compression Vest
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
exercise
Primary Outcome Measure Information:
Title
Change in symptom profile
Description
Timeline to asymptomatic and clinical discharge
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Change in exercise tolerance
Description
Duration and wattage achieved at symptom exacerbation
Time Frame
baseline, four-weeks post-baseline, six-week post-baseline
Secondary Outcome Measure Information:
Title
Anxiety
Description
Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Balance
Description
Change in Stability Index, quantified via BioDex Technology
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Transcranial Doppler Ultrasound - Cerebrovascular Function
Description
Change in middle cerebral artery blood velocity - cm/s
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Heart Rate Variability
Description
Measure of autonomic function - quantified via R-R interval duration (seconds)
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Baroreflex Sensitivity
Description
Measure of autonomic function - quantified via changes in blood pressure for a given heart rate
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Title
Cognitive Function
Description
Cogingram - assessment of psychomotor function, attention, learning and working memory
Time Frame
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
concussed: medically diagnosed with, and being treated for a concussion for no longer than 1 year
healthy volunteer: no previous medical diagnosis of a concussion
Exclusion Criteria:
bone or muscle problems that could impact balance or how well you walk
diagnosis of pre-existing heart disease
medications that affect heart or blood vessel control
pre-existing brain disorders such as Parkinson's, Multiple Sclerosis, Raynaud's, Multiple System Atrophy, metabolic disorders such as diabetes, a history of significant neck injury, or focal neurologic deficit
primary or metastatic bone tumour
severe osteoporosis
if you are, or think you might be, pregnant or breastfeeding
if you are not able to be understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Shoemaker, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Neurovascular Research Laboratory
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
12. IPD Sharing Statement
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Citation
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Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
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