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Spinal Cord Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Jill M Wecht, EdD
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prescription medications have not changed for at least 30 days
SCI between C3-T6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedures (90 minutes)
Awards & highlights
Study Summary
This trial looks at how transcutaneous spinal cord stimulation affects exercise endurance & core body temp in people with chronic spinal cord injury. Participants will receive active & sham stimulation during exercise & in a cold room. No long-term benefits expected.
Who is the study for?
This trial is for adults over 18 with chronic spinal cord injury (SCI) between C3-T6, who have been injured for more than a year and haven't changed their meds in the last month. They should have previously participated in a related SCI study and not be pregnant or suffering from other neurological conditions, heart diseases, severe head trauma, psychological disorders, recent substance abuse, seizures, diabetes or untreated thyroid disease.Check my eligibility
What is being tested?
The study tests if transcutaneous spinal cord stimulation (TSCS) can help people with cervical SCI endure moderate exercise longer and regulate body temperature better compared to sham stimulation. Participants will try both real and fake stimulations while exercising or being exposed to cold temperatures.See study design
What are the potential side effects?
There are no long-term benefits expected from this study; however side effects are not detailed. Typically TSCS might cause discomfort at the stimulation site or skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prescription medications have been the same for the last 30 days.
Select...
My spinal cord injury is between my neck and upper back.
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I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedures (90 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedures (90 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise Endurance Time
Recovery Heart Rate
Tcore
+1 moreSecondary outcome measures
Rate of Perceived Exhaustion
Workload
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcutaneous Spinal Cord StimulationExperimental Treatment1 Intervention
The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.
Group II: Sham Transcutaneous Spinal Cord StimulationPlacebo Group1 Intervention
The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
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Who is running the clinical trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,880 Total Patients Enrolled
3 Trials studying Orthostatic Hypotension
110 Patients Enrolled for Orthostatic Hypotension
Jill M Wecht, EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
3 Previous Clinical Trials
431 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I rely on a ventilator for breathing or have an open tracheostomy.I have had a serious head injury or have been diagnosed with cognitive impairment.You currently have or have had a mental health condition.I have open wounds on my back where a device might be placed.I have a history of seizures.You have taken part in a previous study called 'Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury'.You have used drugs or alcohol heavily in the last 3 months.You have been injured for more than 1 year.I have a history of heart or blood vessel disease.I have diabetes.My prescription medications have been the same for the last 30 days.I have a thyroid condition that hasn't been treated.I have a neurological condition other than spinal cord injury.You have a spinal cord injury classified as AIS A, B, or C.My spinal cord injury is between my neck and upper back.I am over 18 years old.I am currently not suffering from any acute illness or infection.You have medical reasons that make it unsafe for you to receive electrical treatment on your spine.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous Spinal Cord Stimulation
- Group 2: Sham Transcutaneous Spinal Cord Stimulation
Awards:
This trial has 0 awards, including: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.
Are participants currently being sought for this research effort?
"Affirmative, the information on clinicaltrials.gov demonstrates that this experiment is recruiting participants right now. Initially posted on July 30th 2023 and recently updated on August 11th 2023, it aims to enrol a total of twenty individuals from one medical centre."
Answered by AI
How many individuals are being enrolled in this research initiative?
"Affirmative. As indicated by the information on clinical trials gov, this research is actively seeking participants. Originally posted in July 30th 2023 and lastly updated August 11th 2023, it seeks to enroll a total of twenty patients from one medical site."
Answered by AI
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