ALSNCT05287958
Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients
An observational study of ALS, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALS
- What is being tested?
- EIT
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2021to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients clinically diagnosed with ALS
Who may be able to join
- ALS patients able to perform PFT.
- ALS patients recommended for PFT.
- Subjects capable of giving written informed consent.
- Adult, age ≥ 18 years old.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients
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.
Read the 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.
- Conditions
- ALS
- Being tested
- EIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EITDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: EIT | |
| 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. Receives: Diagnostic Test: EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of EIT and PFT measures
A correlation coefficient (-1 to +1) will be used
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
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
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Jul 2021
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Seward Rutkove, Beth Israel Deaconess Medical Center
- Investigators
- Seward Rutkove, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287958
- Sponsor's protocol ID
- 2020C-001010
- Other IDs
- R21NS118434
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients
- ClinicalTrials.gov ID
- NCT05287958
- Acronym / sponsor ID
- 2020C-001010
- Conditions
- ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: EITWhile no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device. |
| ALS | – | Diagnostic Test: EITWhile no intervention or investigational agent will be used in this study, an EIT system will be used, which is a Non-Significant Risk Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients clinically diagnosed with ALS
Key inclusion criteria (4 listed)
- ALS patients able to perform PFT.
- ALS patients recommended for PFT.
- Subjects capable of giving written informed consent.
- Adult, age ≥ 18 years old.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EITEIT 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. | Diagnostic test | ALS, Healthy |
Primary outcome
Correlation of EIT and PFT measures
Time frame: Through study completion, an average of 3 months
A correlation coefficient (-1 to +1) will be used
1 secondary outcome
Assessing differences in lung function images in healthy versus ALS cohorts as generated with EIT
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seward Rutkove, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of EIT and PFT measures (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 3 Nov 2026.