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Electrical Stimulation

Active E-Stim for Muscle Wasting (Phase II Trial)

Phase 2
Waitlist Available
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 an average of 4 weeks (phase ii)
Awards & highlights

Phase II Trial Summary

Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.

Eligible Conditions
  • Muscle Wasting
  • Coronavirus
  • COVID-19
  • Muscle Weakness

Phase II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 4 weeks (phase ii)
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 4 weeks (phase ii) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle Strength
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
Secondary outcome measures
Plantar Oxyhemoglobin

Phase II Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active E-StimActive Control1 Intervention
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Group II: Electrical Stimulation - ShamPlacebo Group1 Intervention
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,233 Total Patients Enrolled
Avazzia, IncIndustry Sponsor
6 Previous Clinical Trials
283 Total Patients Enrolled

Frequently Asked Questions

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~5 spots leftby Apr 2025