NCT05198466: Phase II

Electrical Stimulation for Critically Ill Post-Covid-19 Patients

Completed Phase 2 Results posted Last updated 7 March 2023

What this trial tests

Phase 2 trial testing Electrical Stimulation in COVID-19 in 19 participants. Completed in 18 August 2022.

Timeline

18 August 2021

Primary endpoint
18 August 2022

18 August 2022

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	19
Start date	18 August 2021
Primary completion	18 August 2022
Estimated completion	18 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Electrical Stimulation
• Electrical Stimulation - Sham

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Muscle Atrophy — all drugs for Muscle Atrophy →
• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 100, any sex, with COVID-19 or Muscle Atrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation Primary · an average of 4 weeks (Phase II)

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).

Group	Value	95% CI
Active E-Stim	363.04	± 1.56
Electrical Stimulation - Sham	359.55	± 2.04

Ankle Strength Primary · an average of 4 weeks (phase II).

Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).

Group	Value	95% CI
Active E-Stim	8.5	± 4.2
Electrical Stimulation - Sham	7.9	± 3.7

Plantar Oxyhemoglobin Secondary · an average of 4 weeks (phase II)

Percentage of oxyhemoglobin (OxyHb) 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 OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy.

Group	Value	95% CI
Active E-Stim	.57	± .07
Electrical Stimulation - Sham	.54	± .06

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fostering tissue engineering and regenerative medicine to treat musculoskeletal disorders in bone and muscle.
   Park S, Rahaman KA, Kim YC, Jeon H, et al · · 2024 · cited 33× · PMID 38978804 · DOI 10.1016/j.bioactmat.2024.06.022
2. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial.
   Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, et al · · 2023 · cited 5× · PMID 36905161 · DOI 10.14814/phy2.15636
3. Gastrocnemius electrical stimulation increases ankle dorsiflexion strength in patients with post-acute sequelae of SARS-COV-2 (PASC): a double-blind randomized controlled trial.
   Lee M, Zulbaran-Rojas A, Bargas-Ochoa M, Martinez-Leal B, et al · · 2024 · cited 2× · PMID 39095520 · DOI 10.1038/s41598-024-68100-8