Electrical Impedance Tomography for the Assessment of Neurological Disease

NCT05238038 | Completed

• 1 other identifier: 2019P000431
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time.

Conditions

Neuromuscular Disease Patients; Central Neurological Disease Patients

Outcome Measures

Primary Outcomes (1)

• To establish normative values for EIT data and reproducibility in adult healthy subjects.

  First, we will assess simple percent variability by comparing test-retest measurements and calculating absolute value differences. Secondly, we will perform intraclass correlation analysis of test-retest data. Third, we will perform Bland-Altman analyses with calculation of precision. By performing all three approaches, we will obtain the most complete assessment of the technique's reliability.

  1 year

Secondary Outcomes (1)

• To identify EIT signal data to assist in characterizing muscle as impacted by neuromuscular diseases versus healthy controls versus central neurological conditions.

  1 year

Study Arms (2)

Healthy

EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time

Neuromuscular disease patients and Central neurological disease patients

EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neuromuscular disease patients (well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy) and Central neurological disease patients (well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis)

You may qualify if:

• Age 21 to 80 years

You may not qualify if:

• Generalized neuromuscular disease or debilitated state due to underlying medical disease such as heart failure or malignancy
• Neuromuscular disease patients:
• Age 21 to 80 years;
• History of awell-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.
• \. Multiple generalized neuromuscular conditions.
• Central neurological disease patients:
• Age 21 to 80 years;
• History of a well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis
• \. Multiple generalized neuromuscular conditions.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Study Officials

• Seward Rutkove, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Neurology

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: June 28, 2019
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (1)