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Status:

COMPLETED

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

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

Dartmouth-Hitchcock Medical Center

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

ALS

Eligibility:

All Genders

18+ years

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 wi...

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 Co...

Eligibility Criteria

Inclusion

  • Cohort I
  • ALS patients able to perform PFT.
  • ALS patients recommended for PFT.
  • Subjects capable of giving written informed consent.
  • Adult, age ≥ 18 years old.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 20 2023

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT05287958

Start Date

July 15 2021

End Date

September 20 2023

Last Update

April 16 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

2

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756