Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients

NCT05287958 | Completed

• 2 other identifiers: 2020C-001010R21NS118434
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

• Correlation of EIT and PFT measures

  A correlation coefficient (-1 to +1) will be used

  Through study completion, an average of 3 months

Secondary Outcomes (1)

• Assessing differences in lung function images in healthy versus ALS cohorts as generated with EIT

  Through study completion, an average of 3 months

Study Arms (2)

Healthy

While no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device.

Diagnostic Test: EIT

ALS

While no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device.

Diagnostic Test: EIT

Interventions

EIT DIAGNOSTIC_TEST

EIT comprises a chest belt that is connected to a computer via a universal serial bus (USB) or an Ethernet cable. The chest belt captures EIT data, which is transmitted via the USB or Ethernet cable to the computer. Tomography-like impedance images of the lungs are computed and displayed on the computer. The impedance images will be used to evaluate lung recruitment and other pulmonary function parameters that are currently measured using standard-of-care PFT devices.

ALS; Healthy

Eligibility Criteria

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

Study Population

Patients clinically diagnosed with ALS

You may qualify if:

• ALS patients able to perform PFT.
• ALS patients recommended for PFT.
• Subjects capable of giving written informed consent.
• Adult, age ≥ 18 years old.

You may not qualify if:

• Serious psychiatric illnesses.
• Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
• Skin lesions at chest belt placement sites.
• Pregnant women.
• Patients with primary lung disease, at the discretion of the Investigator.
• Cohort II
• Serious psychiatric illnesses.
• Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
• Skin lesions at chest belt placement sites.
• Pregnant women.
• Subjects with primary lung disease, at the discretion of the Investigator.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dartmouth-Hitchcock Medical Center: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, 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: March 1, 2022
• First Posted: March 18, 2022
• Study Start: July 15, 2021
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: April 16, 2024

Record last verified: 2023-04

Locations

US (2)