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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT00677768
Eligibility Criteria:
1. ALS Volunteers
Inclusion Criteria:
* Diagnosis of possible (excluding volunteers with UMN signs ONLY), probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to revised El Escorial criteria
* Disease duration of less than or equal to two years from symptom onset
* Age 30-80 years at the time of disease onset
* Ability to provide informed consent
* Ability to comply with study procedures
* Medically safe to have lumbar puncture (lumbar puncture volunteers only)
Exclusion Criteria:
* Clinical evidence of chronic liver or renal failure
* Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
* Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
2. Suspected ALS (PMND) Volunteers
Inclusion Criteria:
* Diagnosis of suspected ALS defined as presence of UMN or LMN signs alone and the diagnosis of Clinically Probably Laboratory-Supported ALS CANNOT be proven by evidence in clinical grounds in conjunction with electrodiagnostic, neurophysiologic, neuroimaging or clinically laboratory studies
* Disease duration of less than or equal to four years from symptom onset
* Age 30-80 years at time of disease onset
* Ability to provide informed consent
* Ability to comply with study procedures
* Medically safe to have lumbar puncture (lumbar puncture volunteers only)
Exclusion Criteria:
* Clinical evidence of chronic liver or renal failure
* Genetically confirmed diagnosis of hereditary spastic paraparesis or spinal motor atrophy (SMA) disease
* Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
* Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
3. Neurological Disease Mimic Volunteers
Inclusion Criteria:
Diagnosis of one of the following:
Pure Lower Motor Neuron Disease (LMND) mimics:
* Multi-focal motor neuropathy
* Autoimmune motor neuropathy
* Cervical or lumbosacral radiculopathies
Peripheral mononeuropathies:
* Ulnar neuropathy
* Carpal tunnel syndrome/median neuropathy
* Peroneal neuropathy
* Sciatic neuropathy
* Spinal muscular atrophy
* Spinobulbar muscular atrophy (Kennedy's disease)
* Charcot Marie-Tooth Disease (CMT)
Pure Upper Motor Neuron Disease (UMND) mimics:
* Cervical myelopathy
* Multiple sclerosis
* Hereditary spastic paraparesis
* Age 30-80 years
* Ability to provide informed consent
* Ability to comply with study procedures
* Medically safe to have lumbar puncture (lumbar puncture volunteers only)
Exclusion Criteria:
* Diagnosis of suspected, possible, probable or definite ALS either sporadic or familial
* Presence of positive family history of ALS
* Clinical evidence of chronic renal or liver failure
* Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
* Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
4. Healthy Control Volunteers Inclusion Criteria
* Absence of a known neurological disorder.
* Age 30 - 80 years.
* Ability to provide informed consent.
* Ability to comply with study procedures.
* Medically safe to have lumbar puncture.
Exclusion Criteria:
* History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.
* Presence of positive family history of ALS.
* Clinical evidence of chronic liver or renal failure.
* Presence of bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (LP research volunteers only).
* Research participant must not be taking anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (LP research volunteers only).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT00677768
Study Brief:
Protocol Section:
NCT00677768