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NCT04137159 · ClinicalTrials.gov registry record · NA
An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury
A NA study, sponsored by Spaulding Rehabilitation Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT04137159 is a NA study that was terminated before completion, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 13 participants.
The verdict
NCT04137159, a NA study, was terminated before completion, sponsored by Spaulding Rehabilitation Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Functional Electrical Stimulation rowing exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2024-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04137159
The ClinicalTrials.gov registry entry for NCT04137159 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Functional Electrical Stimulation rowing exercise is the first listed.
NCT04137159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04137159 about?
NCT04137159 is a clinical study titled "An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury". 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 ...
What is the current status of trial NCT04137159?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2020-02-20. Estimated completion is 2024-11-01.
What interventions are being tested in trial NCT04137159?
The interventions under investigation include: Functional Electrical Stimulation rowing exercise (OTHER).
Who is sponsoring clinical trial NCT04137159?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
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