Your session is about to expire
← Back to Search
Electrical Stimulation
Transcutaneous Electrical Nerve Stimulation for Spinal Cord Injury (SCI Trial)
N/A
Recruiting
Led By Caitlyn Peters, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
individuals with traumatic spinal cord injuries at or above T6
non-ambulatory
Must not have
Acute illness or infection
Documented history of controlled or uncontrolled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years
Summary
This trial is testing a new way to help people with spinal cord injuries who often have low blood pressure.
Who is the study for?
This trial is for adults over 18 with traumatic spinal cord injuries at or above T6, who are not able to walk and have had the injury for more than a year. They must be able to give consent, not use a ventilator, and have low blood pressure. People with recent thrombosis, severe contractures, infections, diabetes, other neurological diseases besides spinal cord injury or cardiovascular disease cannot join.
What is being tested?
The study tests how skin stimulation on the back can help control blood pressure in people with spinal cord injuries. It aims to find the best spots for electrode placement and the right settings for frequency and amplitude of stimulation that could improve their cardiovascular health.
What are the potential side effects?
While specific side effects are not detailed here, transcutaneous stimulation may cause discomfort at the site of application or skin irritation. There might also be potential unknown risks related to changes in blood pressure regulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury is at or above the T6 level.
Select...
I cannot walk by myself.
Select...
I am over 18 years old.
Select...
My spinal cord injury is at or above the T6 level.
Select...
My injury occurred over a year ago.
Select...
I cannot walk by myself.
Select...
My spinal injury is classified as severe to moderate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently dealing with an acute illness or infection.
Select...
I have a history of diabetes, whether it's under control or not.
Select...
I have a neurological condition that is not a spinal cord injury.
Select...
I have a history of heart or blood vessel diseases.
Select...
I have had a blood clot or severe muscle tightness in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amplitude of TSCS
Electrode placement
Secondary study objectives
Concentration of Aldosterone
Concentration of Norepinephrine
Concentration of Renin
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: With StimulationActive Control2 Interventions
Participant will complete an orthostatic challenge with transcutaneous stimulation.
Group II: Without StimulationPlacebo Group1 Intervention
Participant will complete an orthostatic challenge without transcutaneous stimulation.
Find a Location
Who is running the clinical trial?
Kessler FoundationOTHER
181 Previous Clinical Trials
11,069 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,794 Total Patients Enrolled
Caitlyn Peters, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart or blood vessel diseases.My injury occurred over a year ago.I cannot walk by myself.I am over 18 years old.I cannot walk by myself.My spinal cord injury is at or above the T6 level.I have had a blood clot or severe muscle tightness in the past year.I am currently dealing with an acute illness or infection.I have a history of diabetes, whether it's under control or not.I have a neurological condition that is not a spinal cord injury.You are not using a ventilator.Your blood pressure is too low. For males, the systolic (top number) is less than 110 or the diastolic (bottom number) is less than 70. For females, the systolic is less than 100 or the diastolic is less than 70.My spinal injury is classified as severe to moderate.My spinal cord injury is at or above the T6 level.You are not using a ventilator.
Research Study Groups:
This trial has the following groups:- Group 1: With Stimulation
- Group 2: Without 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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger