Neuromuscular Disease PatientsNCT05238038
Electrical Impedance Tomography for the Assessment of Neurological Disease
An observational study of Neuromuscular Disease Patients and Central Neurological Disease Patients, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Disease Patients, Central Neurological Disease Patients
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 23 Aug 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neuromuscular disease patients (well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy) and Central neurological disease patients (well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis)
Who may be able to join
- Age 21 to 80 years
- Age 21 to 80 years;
- History of awell-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.
- Age 21 to 80 years;
- History of a well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis
Who cannot join
- Generalized neuromuscular disease or debilitated state due to underlying medical disease such as heart failure or malignancy
- Neuromuscular disease patients:
- 1. Multiple generalized neuromuscular conditions.
- Central neurological disease patients:
- 1. Multiple generalized neuromuscular conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time.
Read the detailed description
- Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time.
- History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form. Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed and the neurological diagnosis confirmed when possible. Information including Body Mass Index (BMI), presence of a gastrostomy, imaging findings, and blood tests will be noted when available. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed. Brief general neurological examinations will then be completed.
- EIT measurements (All participants).We will be using a SwissTom Pioneer EIT data acquisition system. SwissTom has developed a clinical EIT system which is not FDA-approved, although approved in Europe for lung imaging. It comprises an elastic belt that is connected to a computer via a universal serial bus (USB) or an Ethernet cable. Via multiple surface electrodes on the belt, EIT data is captured and transmitted via the USB or Ethernet cable to the computer. Low resolution, tomography-like impedance images of the muscle are computed and displayed on the computer. The impedance images will be used to evaluate muscle recruitment and other muscle function parameters. The data acquisition system includes a unit that transmits a small imperceptible electrical current into the chest, via a pair of operator-selected electrodes, while voltage is sensed on all remaining electrodes. The frequency of the transmitted current ranges from 100 Hz to 1 MHz. For frequencies from 100 Hz to 1 kHz, the current amplitude is limited to a maximum of 0.1 mA. From 1 kHz to 100 kHz, the current amplitude is limited to a maximum of 0.1*f mA, where f is the frequency of the current. For frequencies higher than 100 kHz, the current amplitude is limited to a maximum of 10 mA. This meets the safety requirements for applied current as specified in the International Electrotechnical Commission (IEC) 60601-1 safety standard for medical devices. During data acquisition, the patient may be asked to contract the muscles against resistance of the examiner or against a standard force transducer. The patient may also be asked to contract the muscle while holding a weight in the hand or with a weighted band around the ankle. EIT measurements may be repeated to assess repeatability within the session.
- Ultrasound measurements. An FDA-approved Terason t3000 system may be performed on the muscle or muscle region being assessed in order to better assess the internal anatomy of the region being imaged. These measurements may be done with muscle in a relaxed or a contracted state depending on the specific situation.
- Handheld dynamometry. In patients who have weakness on standard neurological examination, further quantification of weakness may be obtained by performing handheld dynamometry using a MicroFet2 handheld dynamometry (Hoggan Health Industries, Provo, UT) on relevant muscles. A trained examiner may perform all measurements and the best of 3 trials utilized.
- Relevant validated questionnaires. Depending on the disease, appropriate validated scales may be incorporated including the amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R, ALS patients only) or the Unified Parkinson's Disease Rating Scale (UPDRS, Parkinson's Disease patients only).
- Follow-up visits. Depending on the diagnosis, the participant will be asked if they are willing to return for follow-up at some later point (likely 3-months to 1-year later, depending the specific diagnosis and subject convenience).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time | |
| Neuromuscular disease patients and Central neurological disease patients | EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish normative values for EIT data and reproducibility in adult healthy subjects.
First, we will assess simple percent variability by comparing test-retest measurements and calculating absolute value differences. Secondly, we will perform intraclass correlation analysis of test-retest data. Third, we will perform Bland-Altman analyses with calculation of precision. By performing all three approaches, we will obtain the most complete assessment of the technique's reliability.
Measured: 1 year
Secondary outcomes (1)
To identify EIT signal data to assist in characterizing muscle as impacted by neuromuscular diseases versus healthy controls versus central neurological conditions.
We will test for over-fitting the data and ensure that the outcomes used are generally applicable. Initial analysis will consist of one-way ANOVA with post-hoc t-tests to confirm basic discrimination followed by ROC analyses. The goal will be to identify the best set of metrics for disease discrimination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start28 Jun 2019
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Disease PatientsStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- 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
- NCT05238038
- Sponsor's protocol ID
- 2019P000431
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 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
- Electrical Impedance Tomography for the Assessment of Neurological Disease
- ClinicalTrials.gov ID
- NCT05238038
- Acronym / sponsor ID
- 2019P000431
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 14 Feb 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.
Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time.
Detailed description
- Overview of study. This is an observational study that is intended to provide the first in-human data using EIT as a biomarker of muscle health in neuromuscular conditions. We will seek patients with neurological disorders (both neuromuscular and other neurological conditions) as well as healthy subjects for study. EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time.
- History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form. Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed and the neurological diagnosis confirmed when possible. Information including Body Mass Index (BMI), presence of a gastrostomy, imaging findings, and blood tests will be noted when available. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed. Brief general neurological examinations will then be completed.
- EIT measurements (All participants).We will be using a SwissTom Pioneer EIT data acquisition system. SwissTom has developed a clinical EIT system which is not FDA-approved, although approved in Europe for lung imaging. It comprises an elastic belt that is connected to a computer via a universal serial bus (USB) or an Ethernet cable. Via multiple surface electrodes on the belt, EIT data is captured and transmitted via the USB or Ethernet cable to the computer. Low resolution, tomography-like impedance images of the muscle are computed and displayed on the computer. The impedance images will be used to evaluate muscle recruitment and other muscle function parameters. The data acquisition system includes a unit that transmits a small imperceptible electrical current into the chest, via a pair of operator-selected electrodes, while voltage is sensed on all remaining electrodes. The frequency of the transmitted current ranges from 100 Hz to 1 MHz. For frequencies from 100 Hz to 1 kHz, the current amplitude is limited to a maximum of 0.1 mA. From 1 kHz to 100 kHz, the current amplitude is limited to a maximum of 0.1*f mA, where f is the frequency of the current. For frequencies higher than 100 kHz, the current amplitude is limited to a maximum of 10 mA. This meets the safety requirements for applied current as specified in the International Electrotechnical Commission (IEC) 60601-1 safety standard for medical devices. During data acquisition, the patient may be asked to contract the muscles against resistance of the examiner or against a standard force transducer. The patient may also be asked to contract the muscle while holding a weight in the hand or with a weighted band around the ankle. EIT measurements may be repeated to assess repeatability within the session.
- Ultrasound measurements. An FDA-approved Terason t3000 system may be performed on the muscle or muscle region being assessed in order to better assess the internal anatomy of the region being imaged. These measurements may be done with muscle in a relaxed or a contracted state depending on the specific situation.
- Handheld dynamometry. In patients who have weakness on standard neurological examination, further quantification of weakness may be obtained by performing handheld dynamometry using a MicroFet2 handheld dynamometry (Hoggan Health Industries, Provo, UT) on relevant muscles. A trained examiner may perform all measurements and the best of 3 trials utilized.
- Relevant validated questionnaires. Depending on the disease, appropriate validated scales may be incorporated including the amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R, ALS patients only) or the Unified Parkinson's Disease Rating Scale (UPDRS, Parkinson's Disease patients only).
- Follow-up visits. Depending on the diagnosis, the participant will be asked if they are willing to return for follow-up at some later point (likely 3-months to 1-year later, depending the specific diagnosis and subject convenience).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time |
| Neuromuscular disease patients and Central neurological disease patients | – | –EIT measurements will be performed on appendicular muscles (in the upper and lower extremities) depending on the condition, both at rest and with contraction. EIT measurements will be repeated on an intermittent basis to assess repeatability as well disease progression or improvement over time |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neuromuscular disease patients (well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy) and Central neurological disease patients (well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis)
Key inclusion criteria (5 listed)
- Age 21 to 80 years
- Age 21 to 80 years;
- History of awell-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.
- Age 21 to 80 years;
- History of a well-defined disorder affecting the central nervous system that impacts motor function, including stroke, Parkinson's disease, dystonia, and multiple sclerosis
Key exclusion criteria (5 listed)
- Generalized neuromuscular disease or debilitated state due to underlying medical disease such as heart failure or malignancy
- 1. Multiple generalized neuromuscular conditions.
- 1. Multiple generalized neuromuscular conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish normative values for EIT data and reproducibility in adult healthy subjects.
Time frame: 1 year
First, we will assess simple percent variability by comparing test-retest measurements and calculating absolute value differences. Secondly, we will perform intraclass correlation analysis of test-retest data. Third, we will perform Bland-Altman analyses with calculation of precision. By performing all three approaches, we will obtain the most complete assessment of the technique's reliability.
1 secondary outcome
To identify EIT signal data to assist in characterizing muscle as impacted by neuromuscular diseases versus healthy controls versus central neurological conditions.
Time frame: 1 year
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.
Related trials for Neuromuscular Disease Patients
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Disease Patients and Central Neurological Disease Patients, run by Beth Israel Deaconess Medical Center at 1 site 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 5 inclusion and 5 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 1 site 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?
To establish normative values for EIT data and reproducibility in adult healthy subjects. (time frame: 1 year). 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.