Your session is about to expire
← Back to Search
Procedure
Rehabilitation after Surgery for Spinal Cord Injury
Phase 2
Recruiting
Research Sponsored by Burke Medical Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
Demonstrate stability of motor examination for at least six months.
Timeline
Screening 3 days
Treatment 6 weeks
Follow Up 1 year post surgery, immediately post training, minus baseline before surgery
Awards & highlights
Study Summary
This trial will study the effects of rehabilitation on people who have had surgery to improve the function of their arms and hands.
Who is the study for?
This trial is for individuals with tetraplegia due to spinal cord injury who have stable motor function and can consent to the study. They must have specific muscle strength, intact nerve connections as confirmed by tests, and a caregiver for post-surgery therapy. Those with seizure history, metal implants affecting brain stimulation, or unsuitable for surgery are excluded.Check my eligibility
What is being tested?
The study examines how robot-assisted rehabilitation after nerve transfer surgery affects hand function and brain activity in patients with spinal cord injuries. The effectiveness will be measured using clinical assessments of hand/arm function and Transcranial Magnetic Stimulation (TMS) mapping.See study design
What are the potential side effects?
Potential side effects may include discomfort from TMS, surgical risks like infection or poor wound healing, possible pain during rehabilitation exercises, and fatigue associated with intensive physical therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury is classified as A, B, C, or D on the ASIA scale.
Select...
Your motor abilities have not changed for at least six months.
Select...
My paralyzed muscles can still respond to nerve signals.
Select...
My muscles controlled by the nerves for the planned transfer are strong and well-functioning.
Select...
I have someone at home to help me with physical therapy after surgery.
Timeline
Screening ~ 3 days2 visits
Treatment ~ 6 weeks22 visits
Follow Up ~ 1 year post surgery, immediately post training, minus baseline before surgery
Screening ~ 3 days
Treatment ~ 6 weeks
Follow Up ~1 year post surgery, immediately post training, minus baseline before surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Box and Blocks test score
Secondary outcome measures
Modified Ashworth Scale
Single pulse transcranial magnetic stimulation
Spinal Cord Independence Measure (SCIM III)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nerve transfer + robotic trainingExperimental Treatment2 Interventions
Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.
Group II: Nerve transfer + delayed robotic trainingActive Control2 Interventions
Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year + six weeks after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.
Find a Location
Who is running the clinical trial?
Burke Medical Research InstituteLead Sponsor
23 Previous Clinical Trials
1,453 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,933 Previous Clinical Trials
13,198,489 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My muscles controlled by the nerves for the planned transfer are strong and well-functioning.I have had a head injury or struggle with thinking or memory.I cannot have surgery to repair nerve damage.I have someone at home to help me with physical therapy after surgery.I have someone at home to help me with physical therapy after surgery.I have paralysis in all four limbs and some hand movement issues.My paralyzed muscles can still respond to nerve signals.Your motor skills have been consistent and unchanged for the past six months.My spinal cord injury is classified as A, B, C, or D on the ASIA scale.I have a history of seizures or metal implants in my body.Your motor abilities have not changed for at least six months.You are not in stable health.My muscles controlled by the nerves for the surgery are strong and well-functioning.My injury is older than 6 months.My injury is older than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Nerve transfer + robotic training
- Group 2: Nerve transfer + delayed robotic training
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: You will receive the treatment for 6 Weeks
- 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: NCT04041063 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age requirement for this experiment cap off at thirty years old?
"This trial has a specific criterion for applicants: they must be between 18 and 50 years old. Additionally, there are 138 trials available for minors and 741 clinical studies open to seniors aged 65 or above."
Answered by AI
How many participants have the researchers recruited for this investigation?
"Affirmative. Per the data published on clinicaltrials.gov, this medical study is actively enrolling patients who were first posted on July 26th 2019 and has been recently updated as of June 8th 2022. 12 volunteers are required for recruitment from a single site."
Answered by AI
Is recruitment for this research effort still in progress?
"According to clinicaltrials.gov, this experiment is currently seeking applicants. It was originally announced on July 26th 2019 and the listing has been updated most recently on June 8th 2022."
Answered by AI
Has the US Food and Drug Administration sanctioned Nerve transfer surgery?
"Due to the lack of evidence regarding its efficacy, Nerve Transfer Surgery is assigned a score of 2 for safety based on our team's assessment. Nevertheless, there are some data points that suggest it can be safely implemented."
Answered by AI
Is it feasible for me to pursue participation in this medical research?
"This medical investigation is seeking to enrol 12 individuals who have suffered a spinal cord injury and are aged between 18-50. It's important that these patients demonstrate chronicity (6 months since their trauma), stability of motor examination for an equal amount of time, access to postoperative physical therapy assistance at home, muscles innervated by the nerves used as axon donors grading 4/5 or higher with sufficient electrical conductivity."
Answered by AI
Who else is applying?
What state do they live in?
Other
California
New York
Connecticut
How old are they?
18 - 65
What site did they apply to?
Burke Neurological Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What questions have other patients asked about this trial?
How long is each visit and the length of trial?
PatientReceived no prior treatments
Why did patients apply to this trial?
I am continuing my search to get function and healing. I am looking for any improvement to my paraplegic condition. I stand every date with a standard for 1 - 3 hours and use a NuStep for at least 60 minutes daily as well. I am very motivated to try anything to improve my current physical condition.
PatientReceived 2+ prior treatments
It popped I’m up on my IG feed and I feel for certain that I may have beginning signs of a neurological disorder. Just started getting headaches which are uncommon for myself and have been coming on within the past 6 weeks or so. Not sure if neurological however everything I read points out several symptoms. Please have me for this study. Thank you.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger