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Thermal-Aided Muscle Stimulation for Atrophy
N/A
Waitlist Available
Research Sponsored by Niveus Medical, Inc.
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 at 30 s intervals for 20 minutes
Awards & highlights
Study Summary
This trial found that thermal-aided muscle stimulation was more effective than body temperature muscle stimulation for eliciting muscle contraction in the quadriceps.
Who is the study for?
This trial is for adults over 18 without a high BMI (>45), epilepsy, metallic femoral rods, neuromuscular diseases, or severe mobility restrictions. It's not for those who are pregnant, chair- or bed-bound, have pacemakers/defibrillators, or any condition that could affect the study.Check my eligibility
What is being tested?
The study compares two methods to stimulate muscle contraction in the thighs: one using heat plus stimulation and another with normal body temperature. The goal is to see which method works better for improving muscle strength and reducing fatigue.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, skin irritation from the thermal element or electrodes used during treatment sessions. There might also be temporary muscle soreness after treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 s intervals for 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 s intervals for 20 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Muscle Contraction Force
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Body Temperature ControlActive Control1 Intervention
Stimulation performed with body temperature control
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Who is running the clinical trial?
Niveus Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with epilepsy.You have a health condition that may interfere with the study or affect its results according to the investigator's opinion.You have metal rods in your thigh bone.I have a neuromuscular disease or abnormality.You have a pacemaker or defibrillator implanted in your body.I am under 18 years old.My BMI is over 45.I am unable to get out of my chair or bed without help.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Body Temperature Control
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 any vacancies for volunteers in this research initiative?
"As per the information published on clinicaltrials.gov, this particular trial is not currently enrolling participants. The initial posting was made July 1st 2013 with the last update being recorded on 26th of that same month. Despite this study's inactivity, there are still 185 other trials seeking patients at present."
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