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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
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
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
134 Previous Clinical Trials
11,002 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are individuals qualified to partake in this trial?
"For eligibility in this trial, prospective participants must be between the age of 18 and 50 with a spinal cord injury. With 55 spots available, recruitment is ongoing."
Answered by AI
Are there any opportunities to participate in this experiment presently available?
"According to the details found on clinicaltrials.gov, this trial is still recruiting participants. It was first listed in February of 2020 and underwent its most recent amendment in May 2022."
Answered by AI
Are persons aged 40 or over capable of participating in this experiment?
"The researchers are searching for participants that fit the criteria of being over 18 and below 50 years old."
Answered by AI
What is the current sample size of this experiment?
"Affirmative, the listing on clinicaltrials.gov points to this medical project actively recruiting participants. The first post was made on February 20th 2020 and it has been recently updated on May 6th 2022. At present, 55 individuals are being sought from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Maine
What site did they apply to?
Spaulding Rehabilitation Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My sci occurred march 23, 2022 at T12-L1. I am only on state insurance and i am willing to try anything in order to build back muscle and walk again, or to get me as close to that end goal as possible.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I live in maine, will there be somewhere for me to stay while going thru the treatment in boston?
PatientReceived 2+ prior treatments
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