NCT05104710 Intermuscular Coherence as a Biomarker for ALS
| NCT ID | NCT05104710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2021-03-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2021-03-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The specific aims of this study are to: 1. Determine if a painless and quick measurement of muscle activity using surface electrodes can help with the diagnosis of ALS. Specifically, we ask if a measure of intermuscular coherence (IMC-βγ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible. 2. Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity. 3. Follow a cohort of ALS patients longitudinally to determine if IMC-βγ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.
Eligibility Criteria
Inclusion Criteria: * AIM 1: Patients with arm or leg weakness, spastic gait, muscle wasting and/or fasciculations (muscle twitching), dysphagia (difficulty swallowing), dysarthria (difficulty speaking), shortness of breath, hyperreflexia or pathological reflexes, or findings of muscle denervation in previous needle electromyography (EMG) studies. * AIM 2: Subjects between 20 and 90 years of age. * AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS. Exclusion Criteria: * AIM 1: 1. Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation 2. Have significant sensory loss in the weak or spastic limbs 3. Have significant musculoskeletal or neuropathic pain 4. Have an inability or are unwilling to provide informed consent 5. Are unable to perform the study-related task 6. Are taking baclofen or benzodiazepines 7. Have a known non-ALS cause for symptoms * AIM 2: 1. Have a history of neurological disorders such as stroke, neuropathy, or myopathy 2. Have significant pain or sensory loss 3. Are taking baclofen or sedatives such as benzodiazepines 4. Lack of cognitive ability or willingness to provide informed consent * AIM 3: 1. Were unclassified according to the Awaji category or had a defined ALS mimic 2. Are taking baclofen, sedatives or benzodiazepines. NOTE: Participation in a therapeutic clinical trial is NOT an exclusion criterion since this study would not interfere with any potential interventions.
Contact & Investigator
Kourosh Rezania, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT05104710 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05104710 currently recruiting?
Yes, NCT05104710 is actively recruiting participants. Contact the research team at serdarmd@bsd.uchicago.edu for enrollment information.
Where is the NCT05104710 trial being conducted?
This trial is being conducted at Irvine, United States, Miami, United States, Boston, United States, St Louis, United States.
Who is sponsoring the NCT05104710 clinical trial?
NCT05104710 is sponsored by University of Chicago. The principal investigator is Kourosh Rezania, MD at University of Chicago. The trial plans to enroll 650 participants.
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