What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral medications, corticosteroids, and supportive therapies. For treatments similar to Wireless TENS, such as other forms of electrical stimulation, side effects are generally mild and may include sensations like warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain. These treatments are typically well-tolerated with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral drugs like remdesivir and monoclonal antibodies such as bamlanivimab. While the context does not provide specific information on FDA-approved treatments similar to TENS for COVID-19, it does mention a pilot study exploring the use of wireless TENS technology to address post-acute COVID-19 syndrome (PACS) associated fibromyalgia. This suggests ongoing research into non-pharmacologic interventions like TENS for managing symptoms related to COVID-19.

What other types of research exist?

Promising novel alternatives to Wireless TENS for COVID-19 patients in 2024 include: 1) Neuromodulation therapies such as noninvasive median and radial nerve stimulation, which have shown effectiveness in reducing tremor and improving motor function. 2) Adaptive devices like wearable robots and exoskeletons that provide biomechanical loading to support muscle function and reduce pain. 3) High-frequency spinal cord stimulation (SCS), which has demonstrated efficacy in managing chronic pain and improving quality of life in various conditions. These alternatives offer potential benefits for managing pain and improving muscle function in PACS patients.

← Back to Search

Other

Electrical Stimulation for Post-COVID Syndrome (PACS Trial)

N/A

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 4 weeks to 8 weeks

Summary

This trial tests a wireless device that sends gentle electrical pulses to reduce pain and improve symptoms like fatigue and sleep problems. It targets patients with long-term symptoms after COVID-19, similar to fibromyalgia. The device works by blocking pain signals from reaching the brain.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)

Secondary study objectives

Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)

Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)

Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)

+4 more

Other study objectives

Ankle Strength at 4 Weeks (Blinded Phase)

Ankle Strength at 8 Weeks (Unblinded Phase)

Cadence at 8 Weeks During a Dual Task (Unblinded Phase)

+28 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Intervention Group at 4 weeks (blinded phase)Active Control1 Intervention

The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). 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: Intervention Group at 8 weeks (unblinded phase)Active Control1 Intervention

After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). 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 III: Placebo Group at 8 weeks (unblinded phase)Active Control1 Intervention

After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). 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 IV: Placebo Group at 4 weeks (blinded phase)Placebo Group1 Intervention

The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral medications, which inhibit the replication of the virus, and anti-inflammatory drugs, which reduce the excessive immune response that can cause severe complications. Supportive therapies, such as oxygen supplementation and mechanical ventilation, are used to manage respiratory symptoms. These treatments are crucial for reducing viral load, mitigating inflammation, and supporting vital functions, thereby improving patient outcomes. Similar to these treatments, Transcutaneous Electrical Nerve Stimulation (TENS) is being explored for its potential to alleviate pain and improve muscle function in post-acute COVID-19 syndrome by providing electrical impulses that modulate pain perception and enhance muscle performance.

Effectiveness and feasibility of telerehabilitation in patients with COVID-19: a systematic review and meta-analysis.