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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients

Conditions
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ALS

Intervention / Treatment
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* Diagnostic Test: EIT


Participation Criteria
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Eligibility Criteria
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Cohort I Inclusion Criteria: ALS patients able to perform PFT. ALS patients recommended for PFT. Subjects capable of giving written informed consent. Adult, age ≥ 18 years old. Exclusion Criteria: 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 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>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<br>* 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.<br>|
| ALS<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of EIT and PFT measures | A correlation coefficient (-1 to +1) will be used | Through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 3 months |