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Electrical Stimulation for Post-COVID Syndrome (PACS Trial)
N/A
Recruiting
Research Sponsored by Baylor College of Medicine
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 4 weeks from baseline
Awards & highlights
PACS Trial Summary
This trial is testing a new device to help manage pain, fatigue, and other symptoms associated with post-COVID-19 syndrome. The device is worn for 3-5 hours per day for 8 weeks. The study will measure pain symptoms, sleep, fatigue, quality of life, and other outcomes.
Who is the study for?
This trial is for people who've had COVID-19 and are now dealing with ongoing pain, fatigue, weakness, or trouble walking and balancing. They must be able to walk 10 meters on their own and attend clinic visits. It's not for those with certain electronic implants, major foot issues, severe cognitive decline that affects TENS app use, or significant visual/hearing impairments.Check my eligibility
What is being tested?
The study tests a wireless TENS device's ability to relieve Post Acute COVID-19 Syndrome symptoms like muscle pain and fatigue. Participants will be split into two groups: one using real TENS devices (Active) and the other using non-functional ones (Placebo) over an 8-week period with follow-ups at weeks 4 and 8.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of using TENS may include skin irritation where the pads attach, discomfort from electrical stimulation if set too high, or potential interference with existing medical devices.
PACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Fatigue at 4 weeks
Change from baseline in pain scores at 4 weeks
Secondary outcome measures
Change from baseline Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 weeks
Gastrocnemius muscle structure
Change from baseline in Gait assessment at 4 weeks
+1 moreOther outcome measures
Change from baseline in Frailty at 4 weeks
Change from baseline in Plantar tissue oxygen saturation/consumption at 4 weeks
Change in sleep patterns from baseline to 4 weeks
+1 morePACS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Group (AG)Active Control1 Intervention
Active group (AG). The AG (n=20) will be undergoing TENS therapy with an active device during 4 weeks. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
Group II: Placebo Group (PG)Placebo Group1 Intervention
Placebo Group (PG) The PG (n=20) will be undergoing TENS therapy with a sham device as described in the AG. The sham device is identical to the active device in all respects except that it stimulates for 6 minutes during each therapy session instead of 60 minutes, and is therefore 10% of the dose.
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Who is running the clinical trial?
NeuroMetrix, Inc.Industry Sponsor
6 Previous Clinical Trials
400 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,140 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had COVID-19 before.You cannot walk by yourself for 10 meters.You still have pain, tiredness, weakness, or trouble walking after being checked by critical care doctors.You have a demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices that may interfere with the study or increase the risk of using TENS, as determined by doctors.You have a serious foot problem such as open wounds, severe foot deformity, or a history of major foot surgery.You have trouble using the TENS mobile app because of severe memory and thinking problems.You have difficulty seeing or hearing, which makes it hard to use the TENS mobile app.
Research Study Groups:
This trial has the following groups:- Group 1: Active Group (AG)
- Group 2: Placebo Group (PG)
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.
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