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Passive Heat Therapy for Spinal Cord Injury (SCIPHS Trial)
Phase < 1
Recruiting
Led By Michelle B Trbovich, MD
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
Stable SCI over 1 year of duration
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 0 to 8 to 16 weeks
Awards & highlights
SCIPHS Trial Summary
This trial will investigate whether repeated bouts of passive heat stress over a longer term can reduce inflammation, improve metabolism, and vascular function in people with SCI.
Who is the study for?
This trial is for individuals with stable spinal cord injury (SCI) that's been present for over a year. It's not suitable for smokers, those taking daily anti-inflammatory or vasoactive medications, anyone with severe pressure ulcers, or a history of heat-related illness.Check my eligibility
What is being tested?
The study investigates the effects of repeated passive heat stress compared to no treatment on heart disease and diabetes risk factors in people with SCI. Participants will undergo this heating process three times a week for eight weeks to see if it reduces inflammation and improves metabolism and blood vessel health.See study design
What are the potential side effects?
While specific side effects are not listed, passive heat stress may cause discomfort, overheating, dehydration or skin issues at the site of application. Long-term effects are unknown which is why the study excludes individuals with a history of heat-related illnesses.
SCIPHS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury has been stable for over a year.
SCIPHS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 0 to 8 to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 0 to 8 to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
inflammatory markers
Secondary outcome measures
endothelial function
glucose metabolism via oral glucose tolerance test
inflammation
+1 moreOther outcome measures
Chronic pain
Mental Health
Quality of Life
SCIPHS Trial Design
2Treatment groups
Experimental Treatment
Group I: controlExperimental Treatment1 Intervention
passive heat stress x1 visit then no intervention for 8 weeks. participants continue regular exercise habits as usual.
Group II: Passive heat stressExperimental Treatment1 Intervention
After arm 1, passive heat stress 3x/week x8 weeks.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,174 Total Patients Enrolled
Michelle B Trbovich, MDPrincipal InvestigatorSouth Texas Health Care System, San Antonio, TX
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take medication daily to control my blood pressure.I have a severe pressure ulcer.People who smoke cigarettes.I take anti-inflammatory medications every day.My spinal cord injury has been stable for over a year.You have had a sickness caused by being too hot in the past.
Research Study Groups:
This trial has the following groups:- Group 1: control
- Group 2: Passive heat stress
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.
Are there still opportunities for individuals to enroll in this medical experiment?
"According to the information published on clinicaltrials.gov, this medical trial is actively enrolling participants. Its initial posting date was July 1st 2022 and its latest update occurred on July 14th 2022."
Answered by AI
Does this clinical trial have an age-specific enrollment criterion?
"The age range for patients being considered for this trial is 18 and 60 years old."
Answered by AI
What criteria must a person meet in order to qualify as an enrollee of this research project?
"To be eligible for this trial, prospects must have inflammation and fall within the age range of 18 to 60. Presently, there are roughly 10 participants in the study."
Answered by AI
What is the total cohort size for this clinical trial?
"Yes, current information on clinicaltrials.gov indicates that this research study is currently recruiting participants. The trial was first posted on July 1st 2022 and its most recent update happened a fortnight later. Ten volunteers are needed to be recruited from one centre for the project."
Answered by AI
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