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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
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:Select...
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.
Select...
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
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
137 Previous Clinical Trials
11,004 Total Patients Enrolled
Nils C Linnman, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used drugs for fun in the past.My spinal cord injury is at or below C5 and is classified as severe to moderate, occurring within the last 3-24 months.I have a history of epilepsy.I have serious heart rhythm problems.You have smoked or used tobacco in the past.Your blood pressure is higher than 140/90.You have had a serious neurological illness, except for spinal cord injury.You have reasons that make it unsafe for you to undergo a PET scan.I am currently taking medication for my heart.I have a history of heart disease.I have physical issues that may affect my therapy's success.I have had cancer in the past.I have severe skin sores in areas where my body presses against surfaces.You do not respond to FES (functional electrical stimulation) treatment.I have a history of bleeding disorders.I have nerve or shoulder issues that prevent me from rowing.You cannot have an MRI for medical reasons.You have had a serious mental health condition in the past.I have had serious kidney or liver issues in the past.I have unusual findings on my physical exam, like heart murmurs or swelling in my limbs.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.I have a history of diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Wait list
- Group 2: FES rowing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04137159 — N/A
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