Exercise Intervention for Neuropathic Pain After Spinal Cord Injury

Overseen By Andrew Taylor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Cardioactive medications

Disqualifiers: Pregnancy, Diabetes, Heart disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nils C Linnman, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

This trial is for individuals with spinal cord injuries at or below C5, classified as A, B, or C by the American Spinal Injury Association. They should be within 3-24 months post-injury. Excluded are those pregnant, breastfeeding, unable to undergo MRI/PET scans, with major medical/neurological/psychiatric illnesses, diabetes, kidney/liver issues, tobacco/drug use history, certain physical exam abnormalities (like heart murmurs), unresponsive to FES stimulation.

Inclusion Criteria

My spinal cord injury is at or below C5 and is classified as severe to moderate, occurring within the last 3-24 months.

You have a spinal cord injury at or below the C5 level and have a certain level of impairment based on a specific grading system, within 3-24 months after the injury.

Exclusion Criteria

You have used drugs for fun in the past.

I have a history of epilepsy.

I have serious heart rhythm problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Strength Training

Participants undergo strength training with electrodes placed over motor points of the quadriceps and hamstrings to achieve full knee flexion-extension

2-6 weeks

Regular visits for training sessions

FES-RT Treatment

Participants engage in FES-rowing training sessions 3 times per week, aiming for an exercise intensity of 70-85% maintained for a continuous 30-40 min

12 weeks

3 visits per week (in-person)

Wait-list Control

Participants undergo treatment as usual without FES-rowing

12 weeks

Follow-up

Participants are monitored for changes in pain interference, hippocampal volume, and glial activation

4 weeks

Treatment Details

Interventions

• Functional Electrical Stimulation rowing exercise

Trial Overview The trial tests if a 12-week Functional Electrical Stimulation rowing exercise (FES-RT) can reduce neuropathic pain and brain inflammation in people with recent spinal cord injury compared to a wait-list group. It measures changes in pain interference and brain structure/function using advanced imaging techniques like PET and MRI.

Participant Groups

Group I: FES rowing Experimental Treatment 1 Intervention

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.

Group II: Wait list Active Control 1 Intervention

During the 12-week treatment as usual program, subjects will not participate in FES-rowing.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+