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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrical Impedance Tomography for the Assessment of Neurological Disease

NCT05238038

Neuromuscular Disease Patients Central Neurological Disease Patients

COMPLETED

Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials

NCT00620698

Amyotrophic Lateral Sclerosis

COMPLETED

Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis

NCT02528071

ALS (Amyotrophic Lateral Sclerosis)

TERMINATED

Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

NCT05106569

Amyotrophic Lateral Sclerosis

UNKNOWN

Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)

NCT05276349

ALS (Amyotrophic Lateral Sclerosis)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ALS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

EIT

Intervention Type 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

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.

EIT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes