Amyotrophic Lateral Sclerosis
Conditions
Interventions
Use of oral lithium carbonate, in a an initial dosage of 150 mg/Kg/day to achieve serum concentration of 0.4-0.8 mEq / L in patients with a diagnosis of ALS diagnosed by physical examination and elect
Drug
Sponsors
Secretaria de Estado de Saúde do Distrito Federal
Secretaria de Estado de Saúde do Distrito Federal
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years; no upper limit; Disease diagnosis Motor Neuron possible, probable or definite; Exclusion of other diseases by MRI skull and marrow and electromyography; Forced Vital Capacity over 50%. Size of the target sample:100
Exclusion criteria
Exclusion criteria: FVC less than 50% other diseases exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Time for Non-Invasive Ventilation use for more than 12 hours / day for 12 months of follow-up in months. Assessment of Time to tracheostomy in 18 months follow-up. Respiratory Insufficiency development at 24 months, with dessaturation of oxyhemoglobin below 90% and PaO2 below 60 mm Hg in months. Survival Rate at 12, 18 and 24 months with Cox regression and Kaplan Meier with percentual in 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| MUNE (Motor Unit Number Estimation) count every three months for 24 months. ALSFRS-R (Amyotrophic Lateral Sclerosis Fuctional Rating Scale -Revised) every three months for 24 months. Muscle strength evaluation every three months for 24 months. Forced Vital Capacity and Oximetry every three months for 24 months. | — |
Countries
Brazil
Contacts
Public ContactMirian;Mirian Moura;Moura
Secretaria de Estado de Saúde do Distrito Federal;Secretaria de Estado de Saúde do Distrito Federal
Outcome results
None listed