Status:
COMPLETED
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
NeuroMetrix, Inc.
Conditions:
Postacute Sequelae of Sars-CoV-2
Post-Acute COVID-19 Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PASC associated FM. Sample size (n=30) is convenient and designed...
Detailed Description
Postacute Sequelae of Sars-CoV-2 (PASC) is an emerging entity that has been clearly recognized by musculoskeletal pain, fatigue, cognitive, and sleep disturbances, among other symptoms, in patients wh...
Eligibility Criteria
Inclusion
- Previous COVID-19 infection
- Persistent symptoms of pain, fatigue, weakness, or poor gait and balance that were not present before COVID-19 infection
- Willing to attend clinic for assessments
Exclusion
- Severe cognitive decline reduces their ability to interact with the TENS mobile app
- Major visual or hearing weakness reduces the ability to interact with TENS mobile app
- Unable to walk independently for a distance of 10 meter
- Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication
- Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices; and any conditions that may interfere with outcomes or increase the risk of the use TENS based on the judgement of clinicians
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05200858
Start Date
March 1 2022
End Date
December 1 2023
Last Update
July 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030