Electrical Stimulation for Post Acute COVID-19 Syndrome

COVID-19 Clinical Trial

— PACS  

Official title:

Transcutaneous Electrical Nerve Stimulation For Lower Extremity In Patients With Post Acute Covid-19 Syndrome - A Proof Of Concept Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200858
• Other study ID #: H-50753
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Baylor College of Medicine
• Contact: Bijan Najafi, PhD
• Phone: 713-798-7538
• Email: bijan.najafi[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PACS associated FM. Sample size (n=40) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the BCM Post-COVID-19 Clinic for inclusion criteria. Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. One group will utilize TENS functional devices (Active group, AG); the other group will utilize TENS non-functional devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 4 weeks. Then, the patients will come back after four weeks (4W). At this 4th week visit, both groups will be unblinded and the AG will keep their functional device and the PG group will receive a functional device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcomes will be pain symptoms, sleep and fatigue. Secondary outcomes include limb strength and perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, pulse oximetry, and quality of life. The coordinator will utilize a weekly spreadsheet showing utilization (therapy sessions/day, logged in the Quell health Cloud) so compliance can be monitored and those that are not using the device can be encouraged.

Description:

Postacute COVID-19 syndrome (PACS) is an emerging entity that has been clearly recognized by musculoskeletal pain, fatigue, cognitive, and sleep disturbances, among other symptoms, in patients who have recovered from severe Sars-CoV-2 infection. Hospitalized survivors have reported a significant excess burden of many of these symptoms up to 8 months after discharge. Particularly in the lower extremity, musculoskeletal illness has been associated with prolonged immobilization, high-risk comorbidities, and the use of glucocorticoids that is commonly administered to these patients. These manifestations are the cardinal symptoms of fibromyalgia (FM), a condition thought to be caused by hyperactive sensory signaling due to central sensitization as well as deficient endogenous pain inhibition, triggered among others, by viral infections. Consequently, FM sequelae are one of the most common long-term complications seen in PACS. Thus, it is expected to impose a serious burden on different medical specialties in a near future. In a population that has persistent lack of symptom resolution such as FM, adherence to therapy could be challenging. Patients with constant pain, fatigue, and sleep disturbances, are difficult to keep motivated, especially those pain-medication dependents that often present low quality of life. One practical solution to address the symptomatology characteristic of FM is the use of transcutaneous electrical stimulation therapy (TENS). Studies have demonstrated its ability to manage pain and fatigue in patients with peripheral neuropathy and FM, and has shown to effectively improve lower-extremity perfusion and oxygen delivery in patients with ischemic lesions. However, TENS has not yet been explored for PACS. Since this technology is dose-dependent, the investigators propose a practical daily-basis therapy that patients with persistent associated FM due to previous COVID-19 infection could apply at home, thus, addressing PACS without relying only on medication. In this matter, Neurometrix Inc. (Woburn, MA, USA) has created a wireless TENS device (Quell®) to address pain, gait, sleep, and fatigue. This technology is placed in the lower-extremity and works through the stimulation of nerves that carry non-painful sensations (A-beta fibers) by closing a neurological "gate" in the spinal cord, thus, reducing transmission from pain nerves (A-delta and C fibers) to the brain. This device utilizes a wireless technology manageable through a smart phone application (Quell App) that also tracks symptom-status. Moreover, Baylor College of Medicine has created the Post-COVID-19 Clinic (McNair Campus, BCM St Luke's, Houston, TX, USA) supervised by specialists in critical and pulmonary care. This Clinic has a high volume of patients that present with PACS, particularly those with associated FM (i.e., persistent muscle pain, fatigue, weakness, atrophy, sleep problems, and/or anxiety). Therefore, the investigators believe Baylor institution is a suitable place to perform this pilot study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous COVID-19 infection
• Persistent symptoms of pain, fatigue, weakness, or poor gait and balance after infection assessed by critical care clinicians on the initial consultation
• Willing to attend clinic for assessments

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• Muscle Pain
• Muscle Weakness
• Myalgia

Intervention

Device:
• Electrical Stimulation - Active
Subjects will receive an active electrical stimulation device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
• Electrical Stimulation - Placebo
Subjects will receive a placebo electrical stimulation device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	NeuroMetrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Frailty at 4 weeks	Frailty will be measured with a upper-extremity wearable sensor (Frailty meter).	4 weeks from baseline
Other	Change from baseline in Plantar tissue oxygen saturation/consumption at 4 weeks	Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.	4 weeks from baseline
Other	Change in step count from baseline to 4 weeks	Step count will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)	4 weeks from baseline
Other	Change in sleep patterns from baseline to 4 weeks	Sleep patterns data, such as hours of REM and deep sleep, will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)	4 weeks from baseline
Primary	Change from baseline in pain scores at 4 weeks	Pain will be assessed with a validated questionnaire called Brief Pain Inventory, which has a score from 0 (no pain) to 10 (the worst pain).	4 weeks from baseline
Primary	Change from baseline in Fatigue at 4 weeks	Fatigue will be assessed with a validated questionnaire called Multidimensional Assessment Fatigue, which has a score from 0 (no fatigue) to 100 (severe fatigue).	4 weeks from baseline
Secondary	Change from baseline Gastrocnemius muscle strength at 4 weeks	Lower extremity strength will be assessed with an ankle dynamometer and surface electromyography (Delsys Trino Wireless EMG System, MA, US).	4 weeks from baseline
Secondary	Change from baseline Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 weeks	Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).	4 weeks from baseline
Secondary	Change from baseline in Gait assessment at 4 weeks	Gait speed and static balance will be measured with a 6-minute walk test and wearable sensors (Legsys, Balansens, Pampsys).	4 weeks from baseline
Secondary	Change from baseline in Lower extremity peripheral nephropathy at 4 weeks	Peripheral Nephropathy will be assessed with a DPN Check device that measures the signal nerve velocity of a determined nerve section.	4 weeks from baseline