Recruiting

TetraGraph

Sponsor:

Endeavor Health

Code:

NCT07699562

Conditions

ICU Acquired Weakness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

TetraGraph

Electromyography

Nerve conduction studies

Study Details

Brief summary:

This study is testing whether a non-invasive nerve monitoring device (TetraGraph) can accurately detect early signs of ICU-acquired weakness by comparing readings from the device with standard nerve conduction/EMG tests done by a specialist to see if they match. They will focus on muscle response signals in the hand and leg over about 10 days in three groups: healthy volunteers, ICU patients who are not on ventilators, and ICU patients who are on ventilators.

Conditions

ICU Acquired Weakness

Study ID

NCT07699562

Start date

Jun, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Cohort 1: Healthy volunteers

Inclusion criteria:

  • Subjects must be > 18 years old and < 90 years old.
  • Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients

Inclusion criteria:

  • Subjects may be male or female.
  • Subjects must be > 18 years old and < 90 years old.
  • Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).

Cohort 3: Intubated critically ill patients

Inclusion criteria:

  • Subjects may be male or female.
  • Subjects must be > 18 years old and < 90 years old.
  • Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
  • For the Subjects in the ICU that are intubated, they must be planned to be intubated for at least 24 hours.
  • Subjects must be intubated for no longer than ≥ 72 hours before enrollment.

Exclusion Criteria:

  • Cohort 1: Healthy volunteers

Exclusion criteria:

  • Subjects with previous paralysis or neuromuscular disease.
  • Subjects with spinal cord or brain injuries that impact motor function.
  • Subjects with an allergy to clinical adhesive or hydrogel. Cohort 2: Non-intubated critically ill patients

Exclusion criteria:

  • Subjects with previous paralysis or neuromuscular diseases.
  • Subjects with previous peripheral nerve injuries to the tested limbs.
  • Subjects with spinal cord or brain injuries (including stroke) that impact motor function.
  • Subjects without a POA or next of kin for those patients that are unable to consent themselves.
  • Subjects with an allergy to clinical adhesive or hydrogel. Cohort 3: Intubated critically ill patients

Exclusion criteria:

  • Subjects with previous paralysis or neuromuscular disease
  • Subjects with previous peripheral nerve injuries to the tested limbs.
  • Subjects with spinal cord or brain injuries that impact motor function.
  • Subjects without a POA or next of kin for those patients that are in the intubated arm.
  • Subjects with intubations expected to last less than 24 hours.
  • Subjects who have already been intubated for > 72 hours.
  • Subjects with an allergy to clinical adhesive or hydrogel.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy

Healthy volunteers will be recruited primarily through flyers placed in Endeavor Health hospitals and surrounding communities. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

active comparator: Critically Ill patients

Critically ill, non-intubated patients in an Endeavor Health ICU. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

active comparator: Intubated ICU patients

ICU patients that are intubated within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. they will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

Interventions

TetraGraph

The TetraGraph is a non-invasive surface nerve conduction study (NCS) device, currently FDA-approved for monitoring perioperative neuromuscular blockade depth. The device delivers brief (0.2 msec) electrical stimuli to the patient's hand (abductor digiti minimi) or lower leg (tibialis anterior) to monitor the compound action potential.

Electromyography

Electromyography (EMG) is an FDA-approved diagnostic procedure that involves inserting a needle electrode into muscle tissue to record its electrical activity. In this study, EMG findings will primarily be performed to rule out other causes of weakness and to help confirm the suspected diagnosis of CIP and/or CIM.

Nerve conduction studies

Nerve conduction studies (NCS) are FDA-approved diagnostic tests that use surface electrodes to stimulate peripheral nerves and assess nerve function. In this study, NCS findings will be compared to handheld quantitative neuromuscular monitor measurements.

Primary outcome measure

  • bedside quantitative neuromuscular monitoring [ Time Frame: day 1,5, and 10 of enrollment ]

Central Contacts and Locations

Central contacts

Jessica Brickner

847-570-1197jessica.brickner@endeavorhealth.org

Nia Moragne

847-570-1197nia.moragne@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Jessica Brickner

847-570-1197jessica.brickner@endeavorhealth.org

Nia Moragne

847-570-1197nia.moragne@endeavorhealth.org

Principal Investigator:

Cliodhna Ashe, MD

More Information

Sponsor

Endeavor Health

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-07-13.