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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01569958
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
* spinal onset
* aged 18 to 85 years inclusive
* disease duration ≤ 24 months
* disease progression in the past 3 months
* FVC ≥ 70% of predicted
* score ≥ 2 at the item "swallowing"of the ALS Functional Rating Scale Revised
* score ≥ 2 at the item "walking"of the ALS Functional Rating Scale Revised
* in treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
* able to give informed consent
* written informed consent
Exclusion Criteria:
* bulbar onset
* previous poliomyelitis
* motor neuron diseases other than ALS
* clinical involvement of other neurological systems
* pregnancy, lactation,or unwillingness to contraception if required
* possible contraindications to tDCS: metals in the head (excluding the mouth); electromedical devices; seizures; drugs or neurological conditions lowering seizure threshold; alcoholism; severe heart diseases
* any severe disease other than ALS
* experimental drugs within 1 month prior to enrollment
* drugs potentially modifying the response to tDCS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01569958
Study Brief:
Protocol Section:
NCT01569958