An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury
Key facts
- Who runs it
- Spaulding Rehabilitation Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 13 people enrolled
- Started
- 20 Feb 2020
- Ended
- 1 Nov 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Functional Electrical Stimulation rowing exercise
- Record updated
- 9 January 2026
- Why it stopped
- Lack of recruitment
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- SCI at or below neurological level C5 with American Spinal Injury Association grade A, B or C, within 3-24 months after injury
Who cannot take part
- use of recreational drugs
- current use of cardioactive medications
- contraindications to PET current or past history of:
- major medical illness
- major neurological illness other than SCI
- major psychiatric illness
- diabetes
- an abnormal physical exam (e.g., heart murmurs or peripheral edema)
- heart disease
- significant arrhythmias
- cancer
- epilepsy
- history of bleeding disorder
- pregnancy
- breast feeding
- contraindications to MRI
- major kidney or liver problems
- use of tobacco
- unresponsive to FES stimulation
- physical limitations to FES-RT success
- blood pressure>140/90 mmHg
- current grade 2 or greater pressure injuries at relevant contact sites
- peripheral nerve compressions or rotator cuff tears that limit the ability to row
Where in United States
- Spaulding Rehabilitation HospitalBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- FES rowingTreatment being tested
Exercise training sessions will be performed 3 times per week for 12 weeks. The initial training sessions will include 6 sets of FES-rowing for 5 min at 60% of VO2 peak with a work-to-rest ratio of 2:1. Participants unable to row continuously for 5 min will row for 2-4 min with 30-second breaks incorporated until they achieve sets totaling 30 min. The goal is for each volunteer to achieve an exercise intensity of 70-85% maintained for a continuous 30-40 min performed 3 times each week.
Treatment: Functional Electrical Stimulation rowing exercise
- Wait listNo study treatment, for comparison
During the 12-week treatment as usual program, subjects will not participate in FES-rowing.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Exercise Intervention to Educe Neuropathic Pain and Brain Inflammation After Spinal Cord Injury
- Record updated
- 9 January 2026