Amyotrophic Lateral SclerosisNCT02011204
Study of Electrical Impedance Myography (EIM) in ALS
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Skulpt, Inc. at 6 sites in United States.
Trial summary
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Charcot-Marie-Tooth Disease
- What is being tested?
- Electrical impedance myography (EIM)
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2013to Mar 2016
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria) Other Neurological Diseases People with a diagnosis of a disease that mimics ALS Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
Early ALS Inclusion Criteria:
- Sporadic or familial ALS (as defined by revised El Escorial criteria)
- Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.
- Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age
Early ALS Exclusion Criteria:
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
ALS Disease Mimics Inclusion Criteria:
- Diagnosis of one of the following:
- Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity. iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth Disease vi. Any condition that produces generalized or localized weakness without concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating physician deems mimics ALS.
- Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple sclerosis iii. Hereditary spastic paraparesis
ALS Disease Mimics Exclusion Criteria:
- Diagnosis of possible, probable, probable-laboratory supported, or definite ALS
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
Healthy Volunteer Inclusion Criteria:
- Absence of a known neurological disorder.
Healthy Volunteer Exclusion Criteria:
- History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
*Please note that this is not a complete listing on all eligibility criteria.*
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Skulpt, Inc
Boston, Massachusetts, 02210
University of Miami Miller School of Medicine
Miami, Florida, 33136
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
SUNY Upstate Medical University
Syracuse, New York, 13210
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.
Read the detailed description
This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:
- Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
- Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
- Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Charcot-Marie-Tooth Disease, Multiple Sclerosis
- Being tested
- Electrical impedance myography (EIM)
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Charcot-Marie-Tooth Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance myography (EIM)Device
Also called EIM1102 device
In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed.
EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time.
| Study group | Role | What they receive |
|---|---|---|
| People with ALS | People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria)
Intervention: Electrical Impedance Myography (EIM). Receives: Device: Electrical impedance myography (EIM) | |
| Other Neurological Diseases | People with a diagnosis of a disease that mimics ALS Receives: Device: Electrical impedance myography (EIM) | |
| Healthy Controls | Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS. Receives: Device: Electrical impedance myography (EIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination between Groups
Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
Measured: Duration of the Study (9 months for Group A, one visit for Groups B and C)
Secondary outcomes (2)
Tracking Progression
Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care
Measured: Duration of Study, (9 months for Group A, one visit for Groups B and C)
Correlation with Outcome Measures
Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.
Measured: Duration of Study (9 months for Group A, one visit for Groups B and C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skulpt, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Shefner, MD, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011204
- Sponsor's protocol ID
- 2013P001505
- Status last verified
- May 2016
- First submitted
- 3 Dec 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance
- ClinicalTrials.gov ID
- NCT02011204
- Acronym / sponsor ID
- 2013P001505
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Charcot-Marie-Tooth Disease, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Skulpt, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Dec 2013 (estimated)
- 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 trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.
Detailed description
This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:
- Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
- Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
- Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People with ALS | – | Device: Electrical impedance myography (EIM)People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM). |
| Other Neurological Diseases | – | Device: Electrical impedance myography (EIM)People with a diagnosis of a disease that mimics ALS |
| Healthy Controls | – | Device: Electrical impedance myography (EIM)Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria) Other Neurological Diseases People with a diagnosis of a disease that mimics ALS Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
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 |
|---|---|---|
| Electrical impedance myography (EIM)Also: EIM1102 deviceIn EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed. EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time. | Device | Healthy Controls, Other Neurological Diseases, People with ALS |
Primary outcome
Discrimination between Groups
Time frame: Duration of the Study (9 months for Group A, one visit for Groups B and C)
Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
2 secondary outcomes
Tracking Progression
Time frame: Duration of Study, (9 months for Group A, one visit for Groups B and C)
Correlation with Outcome Measures
Time frame: Duration of Study (9 months for Group A, one visit for Groups B and C)
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 11 May 2016.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)
Active, not recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis)
RecruitingObservational study
ASSESS ALL ALS Study
Amyotrophic Lateral Sclerosis
Not yet recruitingPhase 1
Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
Amyotrophic Lateral Sclerosis ALS
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.
Jeremy Shefner, MD, PhD principal investigator
State University of New York - Upstate Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Skulpt, Inc. at 6 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?
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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Discrimination between Groups (time frame: Duration of the Study (9 months for Group A, one visit for Groups B and C)). 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 11 May 2016.