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Transcranial Magnetic Stimulation for Spinal Cord Injury (uMEP Trial)
N/A
Recruiting
Led By Blair Dellenbach, MSOT
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and final training session (approximately 2.5 months)
Awards & highlights
uMEP Trial Summary
This trial is testing if transcranial magnetic stimulation can help improve movement in people with incomplete spinal cord injury.
Who is the study for?
This trial is for individuals with incomplete spinal cord injury who are over 6 months post-injury, medically stable, and not expecting medication changes for 3 months. They must have weak wrist extension but can still move their arm voluntarily. People with motoneuron injuries, cognitive impairments, seizures, metal in the skull, pregnancy or certain implants cannot join.Check my eligibility
What is being tested?
The study tests if training the brain-to-muscle pathway using a magnetic stimulator improves arm movement in those with spinal cord injuries. Participants will train their wrist extensor muscle response to this stimulation over 30 visits lasting about 1.5 hours each.See study design
What are the potential side effects?
Using transcranial magnetic stimulation may cause little to no discomfort; however specific side effects aren't detailed here. It's generally considered safe but could potentially trigger headaches or scalp sensations at the site of stimulation.
uMEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and final training session (approximately 2.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and final training session (approximately 2.5 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
+5 moreuMEP Trial Design
1Treatment groups
Experimental Treatment
Group I: MEP Wrist Extensor Up-ConditioningExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,610 Total Patients Enrolled
Blair Dellenbach, MSOTPrincipal InvestigatorMedical University of South Carolina
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have metal implants in my head.I have difficulty with memory or thinking clearly.I am not pregnant.I have a history of epileptic seizures.I cannot voluntarily move my wrist.My weaker arm will be the focus if I have weakness in both wrists.I use electrical stimulation on my arm every day.My current medication will not change for the next 3 months.I have had a spinal cord injury at or above the C6 level.I have weak wrist extension in at least one of my wrists.I have a motor neuron injury.My tests show no muscle response in my forearm.My spinal cord injury has been stable for over 6 months.I have been on a steady dose of medication for muscle stiffness.
Research Study Groups:
This trial has the following groups:- Group 1: MEP Wrist Extensor Up-Conditioning
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count for this experiment?
"Verified, the clinical trial is currently recruiting. The investigation was published on December 10th 2021 and updated most recently on April 8th 2022. Five individuals will be admitted to a single research centre."
Answered by AI
Are investigators currently accepting participants for this trial?
"According to information posted on clinicaltrials.gov, this medical endeavour is currently searching for participants. This trial was initially made public on October 12th 2021 and underwent its most recent revision April 8th 2022."
Answered by AI
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