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

ALS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287958
• Other study ID #: 2020C-001010
• Secondary ID: R21NS118434
• Status: Completed
• Start date: July 15, 2021
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALS

Intervention

Diagnostic Test:
• EIT
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dartmouth-Hitchcock Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of EIT and PFT measures	A correlation coefficient (-1 to +1) will be used	Through study completion, an average of 3 months
Secondary	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