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

Completed

• Conditions: ALS
• Interventions: Diagnostic Test: EIT

• Registration Number: NCT05287958
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

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 Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Status Verified: 2023-04
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

2. Serious psychiatric illnesses.

3. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.

4. Skin lesions at chest belt placement sites.

5. Pregnant women.

6. Subjects with primary lung disease, at the discretion of the Investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	EIT	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.
ALS	EIT	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.

Primary Outcome Measures

Name	Time	Method
Correlation of EIT and PFT measures	Through study completion, an average of 3 months	A correlation coefficient (-1 to +1) will be used

Secondary Outcome Measures

Name	Time	Method
Assessing differences in lung function images in healthy versus ALS cohorts as generated with EIT	Through study completion, an average of 3 months	Correlation coefficient (-1 to +1) will be used to compare regions of interest

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States