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

Beth Israel Deaconess Medical Center58 enrolled

Overview

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.

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. For both Cohort I and II, subject participation will require two visits (initial and 3-4 month follow up), which are expected to last approximately 30 minutes. Subjects will undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure. The actual EIT imaging will last for 10 to 15 minutes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

ALS

Interventions

EITDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Cohort I Inclusion Criteria: 1. ALS patients able to perform PFT. 2. ALS patients recommended for PFT. 3. Subjects capable of giving written informed consent. 4. Adult, age ≥ 18 years old. Exclusion Criteria: 1. Serious psychiatric illnesses. 2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires. 3. Skin lesions at chest belt placement sites. 4. Pregnant women. 5. Patients with primary lung disease, at the discretion of the Investigator. Cohort II 1\. Subjects capable of giving written informed consent; 2. Subjects capable of performing a PFT; 3. Adult, age ≥ 18 years old 10.2.2 Exclusion Criteria 1. Serious psychiatric illnesses. 2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires. 3. Skin lesions at chest belt placement sites. 4. Pregnant women. 5. Subjects with primary lung disease, at the discretion of the Investigator.

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Correlation of EIT and PFT measures

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

Time frame: Through study completion, an average of 3 months

Secondary Outcomes

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

Correlation coefficient (-1 to +1) will be used to compare regions of interest

Time frame: Through study completion, an average of 3 months

Data from ClinicalTrials.gov

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