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:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02124057
Eligibility Criteria:
* INCLUSION CRITERIA:
The study population will consist of several subgroups of patients. An individual must meet one of the following subgroup inclusion criteria to participate in this study.
SBMA subgroup:
1. Male
2. Genetically confirmed SBMA
3. Able to travel to the NIH
4. Greater than 18 years old
SBMA carriers:
1. Female
2. Genetically confirmed SBMA heterozygote
3. Able to travel to the NIH
4. Greater than 18 years old
Other motor neuron disease patients:
1. Diagnosis of motor neuron disease other than SBMA (e.g.. amyotrophic lateral sclerosis (ALS), spinal muscular atrophy)
2. Able to travel to the NIH
3. Greater than 18 years old
4. . Male
Healthy male control:
1. Male
2. No history or diagnosis of liver disease
3. No history of SBMA or other motor neuron disease
4. Greater than 18 years old
5. No diagnosis of diabetes or insulin resistance
6. No history of alcohol abuse within the last 1 year
7. No history of hyperlipidemia (LDL \< 195) or hypertriglyceridemia (TAG \< 225)
Healthy female control:
1. Female
2. No history or diagnosis of liver disease
3. No history of SBMA or other motor neuron disease
4. Greater than 18 years old
5. No diagnosis of diabetes or insulin resistance
6. No history of alcohol abuse within the last 1 year
7. No history of hyperlipidemia (LDL \< 195) or hypertriglyceridemia (TAG \< 225)
EXCLUSION CRITERIA:
* Diagnosed with an acquired or inherited liver disease eg., hepatitis B, hepatitis C, HIV, autoimmune hepatitis, cholestatic liver disease, Wilson s disease, iron overload disease, alpha-1 antitrypsin deficiency, hepatocellular carcinoma, (hepatic neoplasm or metastasis, etc.) or injury except for fatty liver disease.
* Contraindications to MRI such as a contraindicated non-removable metal device (i.e. pacemaker, defibrillator, insulin pump, metal clips, non-removable jewelry) or claustrophobia.
* Currently pregnant or pregnant within the past 6 months. Pregnant women are excluded from the study because of the known associated abnormalities in liver function that can occur in this population. The long term effects of MRI on the developing fetus are unknown and would present a risk with participation.
In addition to the above criteria, the patients receiving a liver biopsy will need to meet the additional exclusion criteria below:
* Coagulopathy (PT/PTT values that are prolonged \>= 3 seconds from the upper limit of normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\< 70,000), abnormal bleeding time or platelet dysfunction.
* Taking anti-platelet agents for cardiovascular protection that cannot be safely stopped for the performance of the liver biopsy.
* Obesity, which is defined as a BMI\>30 at the screenig visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02124057
Study Brief:
Protocol Section:
NCT02124057