ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients.

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT07699562
Status
Recruiting
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Conditions

  • ICU Acquired Weakness

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • TetraGraph — DEVICE
    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 — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor HealthEvanstonIllinois60201
Jessica Brickner
[email protected]
847-570-1197
Nia Moragne
[email protected]
847-570-1197
Cliodhna Ashe, MD (PRINCIPAL_INVESTIGATOR)

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