Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2

NCT05200858 | Completed Results FDA Device

• 1 other identifier: H-50753-A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 to explore acceptability and feasibility. 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 high-dose devices (Intervention group, IG); the other group will utilize TENS low-dose 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 IG will keep their high-dose TENS device and the PG group will switch from a low-dose TENS to a high-dose TENS device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcome will be pain. Secondary outcomes include fatigue, limb strength and perfusion, gait assessment (cadence, stride time, double support), 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.

Conditions

Postacute Sequelae of Sars-CoV-2; Post-Acute COVID-19 Syndrome; Widespread Chronic Pain; Fatigue Syndrome, Chronic; Gait, Unsteady

Keywords

Transcutaneous nerve electrical stimulation; Pain; Fatigue

Outcome Measures

Primary Outcomes (1)

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

  Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.

  baseline to 4 weeks

Secondary Outcomes (7)

• Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)

  Baseline to 4 weeks

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

  Baseline to 4 weeks

• Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)

  at 4 weeks

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

  at 4 weeks

• Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)

  at 4 weeks

Other Outcomes (31)

• Stride Time at 4 Weeks During a Dual Walking Task (Blinded Phase)

  at 4 weeks

• Stride Time at 4 Weeks During a Fast Walking Task (Blinded Phase)

  at 4 weeks

• Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 Weeks (Blinded Phase)

  at 4 weeks

Study Arms (4)

Intervention Group at 4 weeks (blinded phase)

ACTIVE COMPARATOR

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.

Device: TENS - high-dose

Placebo Group at 4 weeks (blinded phase)

PLACEBO COMPARATOR

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).

Device: TENS - low-dose

Intervention Group at 8 weeks (unblinded phase)

ACTIVE COMPARATOR

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.

Device: TENS - high-dose

Placebo Group at 8 weeks (unblinded phase)

ACTIVE COMPARATOR

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.

Device: TENS - high-dose

Interventions

TENS - high-dose DEVICE

Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.

Also known as: functional, commercial

Intervention Group at 4 weeks (blinded phase); Intervention Group at 8 weeks (unblinded phase); Placebo Group at 8 weeks (unblinded phase)

TENS - low-dose DEVICE

Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day.

Also known as: placebo, sham

Placebo Group at 4 weeks (blinded phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• NeuroMetrix, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Chronic Pain; Fatigue Syndrome, Chronic; Gait Disorders, Neurologic; Pain; Fatigue

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Prof. Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Devices may be high-dose (delivering 100% of the dose) or low-dose (delivering 10% of the dose) TENS
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: 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 high-dose devices (Intervention group, IG); the other group will utilize TENS low-dose devices (Placebo group, PG). Both groups will receive their respective devices at the initial visit (BL) and will be asked to return in 4 weeks for follow-up assessment (4W visit). At this 4 week visit, study participants will be unblinded and the IG will keep their high-dose device, while the PG will switch from low-dose to high-dose TENS device. Study participants will return for a final in-person visit at the 8th week (8W), which will include the assessments described above. Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep the commercial (high-dose TENS) device after completion of the 8-week study.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 21, 2022
• Study Start: March 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Locations

US (1)