Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT05854433
Eligibility Criteria:
DM 2 Inclusion Criteria:
* Age 40 and older
* Diagnosis of DM1 or DM2 is based on genetic testing and/or clinical criteria. If the diagnosis is based on clinical criteria, positive DM2 genetic testing is required in first-degree relatives
* Symptoms or clinical findings of proximal muscle weakness
* Ambulate independently (a cane or walking stick is permitted)
* Able to provide informed consent for participation in the study
DM1 Inclusion Criteria:
* Age 20 and older. Only individuals who are 40 years or older will be eligible to participate for the full study protocol
* Diagnosis of adult-onset DM1 is based on genetic testing or clinical criteria. If the diagnosis is based on clinical criteria, positive DM1 genetic testing is required in first-degree relatives
* The onset of first symptoms must be between the 2nd and 4th decades of life
* Symptoms or clinical findings of distal muscle weakness and myotonia
* Ambulate independently (a cane or walking stick is permitted)
* Able to provide informed consent for participation in the study
DM 1 Exclusion Criteria:
* Congenital or juvenile-onset DM1 (onset of first symptom \< 20-year-old)
* Individuals with a prior diagnosis of dementia, seizure, stroke, multiple sclerosis, Parkinson's Disease, or other neurodegenerative diseases
* Individuals with active psychiatric illness or alcohol/substance abuse.
* On medications with substantial sedative or cognitive side effects unless the doses have been stable for at least 3 months before the study visit.
* Inability or unwillingness to give written informed consent.
DM 1 and 2 and Healthy Control (HC) Exclusion Criteria:
* Individuals with a pacemaker, defibrillator, or metal implanted that is contraindicated for MRI
* Individuals who are claustrophobic
* Individuals with a prior diagnosis of dementia, seizure, stroke, multiple sclerosis, Parkinson's Disease, or other neurodegenerative diseases
* Individuals with active psychiatric illness, alcohol or substance abuse, or dependence
* Individuals with a pacemaker, defibrillator, or metal implanted that is contraindicated for MRI
* Individuals who are claustrophobic
* Major medical illness which would prevent safe testing of MRI or motor function.
* On medications with substantial sedative or cognitive side effects unless the doses have been stable over the last 3 months before the study visit
* pregnancy
* Weight \> 400 pounds as the participant could not be properly positioned on the MRI table
* Inability or unwillingness to give written informed consent
* For participants who undergo lumbar puncture procedure: Use of anti-platelet medications within 7 days, use of anticoagulants such as warfarin (Coumadin), history of a bleeding disorders, evidence of platelet count \< 150,000 within the last 6 months, or have hardware (i.e., pins, screws, rods, etc.) in the lower back area
Healthy Control (HC) Inclusion Criteria:
* Age 40 and older
* Ambulate independently
* Able to provide informed consent for participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05854433
Study Brief:
Protocol Section:
NCT05854433