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Exercise Intervention for Neuropathic Pain After Spinal Cord Injury

N/A

Waitlist Available

Led By Nils C Linnman, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

History of epilepsy

Significant arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and after 12 week fes intervention, and after 12 week wait list

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how functional electrical stimulation (FES) can help people with spinal cord injuries by reducing pain, improving brain function, and increasing the size of the hippocampus.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information about this clinical trial's interventions side effects may include muscle soreness or fatigue from exercise. There could also be skin irritation where electrodes are placed for FES.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of epilepsy.

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I have serious heart rhythm problems.

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I am currently taking medication for my heart.

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I have a history of heart disease.

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I have had cancer in the past.

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I have severe skin sores in areas where my body presses against surfaces.

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I have a history of bleeding disorders.

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I have nerve or shoulder issues that prevent me from rowing.

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I have had serious kidney or liver issues in the past.

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I have unusual findings on my physical exam, like heart murmurs or swelling in my limbs.

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I have a history of diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and after 12 week fes intervention, and after 12 week wait list

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and after 12 week fes intervention, and after 12 week wait list

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and after 12 week fes intervention, and after 12 week wait list for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Change in Hippocampal volume

Change in Hippocampus glial activation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FES rowingExperimental Treatment1 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 listActive Control1 Intervention

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

0 / 11Eligibility criteria met