Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome

NCT06238609 | Active Not Recruiting Results FDA Device

• 1 other identifier: H-52968
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Post-intensive care syndrome (PICS) encompasses persistent physical, cognitive, and psychiatric symptoms following ICU discharge, commonly triggered by serious conditions such as respiratory failure, sepsis, and mechanical ventilation. PICS prevalence is reported to be as high as 84% up to 12 months in patients with at least 2 days spent in the ICU or with mechanical ventilatory support. As a consequence, many patients do not return to they former level of function for weeks, months and even years. Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. This affection is referred to as CU-Acquired Weakness (ICUAW). One third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand. However achieving this early intervention is not always feasible due to time or personnel constraints. The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU.

Conditions

Muscle Atrophy; Muscle Weakness; Blood Flow

Keywords

neuromodulation; skin perfussion; muscle dysfunction

Outcome Measures

Primary Outcomes (1)

• Gastrocnemius Muscle Endurance at Endpoint

  Gastrocnemius muscle endurance was assessed by measuring sustained involuntary muscle contractions using surface electromyography (sEMG; Delsys Trigno). During a 60-minute electrical stimulation therapy session, sEMG signals were recorded from the last two minutes of the therapy to evaluate muscle activity in response to electrical stimulation. The recorded sEMG data were normalized to the average sEMG signals captured during the same interval, yielding values in normalized units (n.u.), higher values indicate higher muscle endurance. The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first.

  Up to 4 weeks

Secondary Outcomes (5)

• Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline

  Up to 4 weeks

• Percentage of Tissue Oxygen Saturation at Endpoint

  up to 4 weeks

• Ankle Strength at 4 Weeks

  up to 4 weeks

• Sural Nerve Conduction at 4 Weeks

  up to 4 weeks.

• Sural Nerve Amplitude at 4 Weeks

  up to 4 weeks.

Other Outcomes (5)

• Anxiety Level 4 Weeks After Hospital Discharge

  1 month after study termination (up to 8 weeks).

• Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge

  1 month after study termination (up to 8 weeks).

• Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge

  1 month after study termination (up to 8 weeks).

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

Device: Intervention Group

Control group

SHAM COMPARATOR

Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

Device: Control Group

Interventions

Intervention Group DEVICE

Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

Intervention Group

Control Group DEVICE

Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

Control group

Eligibility Criteria

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

You may qualify if:

• Any patient older than 18 years old admitted to the ICU within 2 days.
• Patient can be intubated with ventilatory assistance or not.

You may not qualify if:

• Less than 48 hours of ICU stay.
• Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), and/or previous major amputations.
• Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices.
• Any conditions that may interfere with outcomes or increase the risk of the use neuromodulation therapy based on the judgement of clinicians.

Sponsors & Collaborators

• Bijan Najafi, PhD: lead
• Avazzia, Inc: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636.

  PMID: 36905161 RESULT

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Limitations: EMG reading can be affected by variation in skin conductivity. Factors such as dry skin, sweat, edema, can alter electrical conductivity of skin, potentially leaidng to some inacurracies in readings. Muscle ultrasound: Highly user dependence. Also limitations exist when this modality is used for repeated measurments. Ensuring position and location of the probe during each scan is challenging and can result in measurment variablity.

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 active or sham.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily neuromodulation in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The neuromodulation device will be functional for IG and non-functional for CG. Phase I will include patients admitted to the Intensive care Unit. The study duration will be 4 weeks or until hospital discharge, whichever comes first.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: August 28, 2023
• Primary Completion: June 26, 2024
• Study Completion: August 28, 2025
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Locations

US (1)