Spinal Cord Injuries Clinical Trial
Official title:
An Exercise Intervention to Educe Neuropathic Pain and Brain Inflammation After Spinal Cord Injury
Verified date | February 2024 |
Source | Spaulding Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spinal Cord Injury (SCI) leads to alterations in brain structure and function by spinal nerve damage, secondary inflammatory responses, and by the consequences of living with paralysis and neuropathic pain. Physical inactivity due to lower body paralysis rapidly leads to loss of muscle, and risk of heart disease. The leading cause of death after a spinal cord injury is cardiovascular disease, and just a year after injury, those with SCI have a peak exercise capacity half that of the unfit general population. The good news is that aerobic exercise reduces the risk of chronic metabolic and cardiorespiratory diseases, reduces inflammation and pain, and increases mood and quality of life. Exercise can also reduce brain inflammation, enhance endogenous analgesia, and increases the size of the hippocampus. The issue is that muscle paralysis in SCI restricts the ability to achieve the levels of exercise that is necessary for broad analgesic, anti-inflammatory and neuroprotective benefits. Arm exercise can have some effects on heart and lung capacity, but the small muscle mass is insufficient to produce more than modest aerobic work. With functional electrical stimulation (FES), leg muscles that are paralyzed can be made to contract, thereby allowing more of the body to be exercised. The full rowing stroke is produced by both the (stimulated) legs and arms, increasing the active muscle mass and resulting in an aerobic work-out that is intensive enough to improve heart, lung, and - maybe - brain function. In this clinical trial of sub-acute spinal cord injured subjects, the investigators will study how 12 weeks of FES-RT, in comparisons to 12 weeks of wait-list, changes pain, brain structure, endogenous opioid function and brain inflammation. The investigators will measure changes using positron emission tomography and magnetic resonance imaging. The investigators hypothesize a decrease in pain interference, an increase in hippocampal volume, increased endogenous opioid transmission in the periaqueductal gray, and decreased hippocampus neuroinflammation.
Status | Active, not recruiting |
Enrollment | 13 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: * SCI at or below neurological level C5 with American Spinal Injury Association grade A, B or C, within 3-24 months after injury. Exclusion Criteria: - pregnancy - breast feeding - contraindications to MRI - contraindications to PET current or past history of: - major medical illness - major neurological illness other than SCI - major psychiatric illness - diabetes - major kidney or liver problems - use of tobacco - use of recreational drugs - an abnormal physical exam (e.g., heart murmurs or peripheral edema). - unresponsive to FES stimulation - heart disease - physical limitations to FES-RT success - blood pressure>140/90 mmHg - significant arrhythmias - cancer - epilepsy - current use of cardioactive medications - current grade 2 or greater pressure injuries at relevant contact sites - peripheral nerve compressions or rotator cuff tears that limit the ability to row - history of bleeding disorder |
Country | Name | City | State |
---|---|---|---|
United States | Spaulding Rehabilitation Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Spaulding Rehabilitation Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PROMIS Pain Interference questionnaire | The Patient-Reported Outcomes Measurement Information System (PROMIS(r)) Pain Interference instrument measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life.
The scale ranges from 6 to 30, with 30 being the highest pain interference. |
Change between baseline and after 12 week FES intervention, and after 12 week wait list | |
Primary | Change in Hippocampal volume | MRI derived measurement of hippocampus volume | Change between baseline and after 12 week FES intervention, and after 12 week wait list | |
Primary | Change in Hippocampus glial activation | 11C-PBR28 SUV uptake in the hippocampus | Change between baseline and after 12 week FES intervention, and after 12 week wait list | |
Primary | Change PAG opioid binding potential | Non-displaceable opioid binding potential of the periaqueductal gray | Change between baseline and after 12 week FES intervention, and after 12 week wait list |
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