Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 80 years old
• People who have been diagnosed with ALS (either sporadic or familial), at any level of diagnostic certainty under the revised El Escorial criteria
• People whose ALS symptoms first appeared 3 years ago or less
• People whose lung breathing capacity (Slow Vital Capacity) is at least 50% of the expected level for their age and size, measured with a breathing device at screening
• People whose nerve signal strength in the arms (median CMAP) is at least 1.5 mV — this applies to a specific part of the study called TTNCS (confirm with trial site)
• People willing to avoid certain treatments during the study, including botulinum toxin (e.g. Botox), phenol or alcohol injections, intrathecal baclofen (a pump-delivered muscle relaxant), digitalis, and morphine
• People willing to avoid participating in any other clinical trial or experimental treatment for ALS during this study
• Women who are not able to become pregnant — for example, due to menopause, surgery, or use of adequate contraception — for the duration of the study and for 3 months after it ends
• People who have been on a stable dose of riluzole (Rilutek), edaravone (Radicava), or tofersen (Qalsody), and/or stable oral medications for muscle spasms or cramps, for at least 30 days before the study begins
• People whose ALS Functional Rating Scale score (ALSFRS-R) is 35 or higher — this is a standard measure of how ALS is affecting daily functioning
• People who are willing and able to give informed consent to participate

Who may not be able to join:

• People who are on permanent assisted ventilation, meaning they rely on a breathing machine for more than 22 hours a day for more than 7 days in a row
• People whose ALS affects only the bulbar region (the muscles controlling speech and swallowing), with no limb involvement
• People who have an intrathecal pump already implanted (a device that delivers medication directly into the spinal fluid)
• People who have had botulinum toxin injections anywhere in the body within the past 12 weeks
• People who have had phenol or alcohol injections for muscle stiffness within the past 6 months
• People with certain risk factors related to the brain and spinal stimulation techniques used in this trial, including:
  • Damaged, broken, or recently scarred skin at the areas where stimulation would be applied
  • An implanted device that is activated electrically, magnetically, or mechanically — such as a cardiac pacemaker — with the exception of loop recorders
  • Ferromagnetic (magnetic) metal anywhere in the head, neck, or stimulation sites — such as aneurysm clips, implanted brain stimulators, cochlear implants, or metal from an old injury (note: dental fillings are permitted, and jewellery must be removed during stimulation)
  • A seizure or unexplained loss of consciousness in the past 12 months
  • A heart condition that could be made worse by electrical stimulation through the chest
  • A history of spinal cord damage or previous spinal surgery that may interfere with the procedure, as assessed by the study doctor
  • A history of brain lesions, stroke affecting the brain's outer layer, or previous brain surgery that may interfere with the brain stimulation part of the study, as assessed by the study doctor
• People with any medical condition that would prevent them from completing the trial's assessments or outcome measures
• Women who are pregnant, as confirmed by a pregnancy test at the first visit

Important: Always verify eligibility with the trial site directly before applying.