ALS
Conditions
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.
Interventions
DIAGNOSTIC_TESTEIT
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.
Sponsors
Dartmouth-Hitchcock Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Beth Israel Deaconess Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of EIT and PFT measures | Through study completion, an average of 3 months | A correlation coefficient (-1 to +1) will be used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed