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| ID | Type | Description | Link |
|---|---|---|---|
| R21NS118434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of EIT and PFT measures | A correlation coefficient (-1 to +1) will be used | Through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Cohort I
Inclusion Criteria:
Exclusion Criteria:
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
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Patients clinically diagnosed with ALS
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| Name | Affiliation | Role |
|---|---|---|
| Seward Rutkove, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Dartmouth-Hitchcock Medical Center |
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| Lebanon |
| New Hampshire |
| 03756 |
| United States |