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 between 18 and 70 years old
• People who have been diagnosed with locked-in state (a condition where a person is conscious but unable to move or speak), or who are likely to progress into this state within an estimated 2 years, due to a brain injury, brainstem stroke, a nerve or muscle disease, or another cause
• People who currently have, or are expected to soon develop, little to no movement in both arms and legs
• People who currently have, or are expected to soon develop, severely reduced or absent ability to produce speech due to muscle-related causes
• People who are either already breathing through a tracheostomy (a breathing tube in the throat), or whose breathing is stable enough to safely undergo surgery with a breathing tube, and — if their condition is progressive — who have confirmed they would want a tracheostomy if it becomes necessary in the future
• People who meet the medical safety requirements for surgery, as assessed by the study doctors
• People who meet the psychological and neurological evaluation requirements set by the study team
• People who are able to communicate reliably, for example by moving their eyes
• People who are willing and able to give informed consent to participate
• People who live within a reasonable distance from University Medical Center Utrecht in the Netherlands
• People who still wish to participate at the time the study procedures take place
• People whose vision and hearing are largely intact

Who may not be able to join:

• People whose neuropsychological testing results show a significant current or recent psychiatric condition, or a cognitive or behavioural difficulty that would affect their ability to consent or fully take part in the study
• People with medical conditions that make surgery for a long-term implanted device unsafe or that could interfere with participation — this includes (but may not be limited to) active infections, unexplained fever, existing scalp wounds or skin breakdown, bone infections, hepatitis, autoimmune conditions, epilepsy, skin conditions that affect wound healing, prior skull repair surgery (cranioplasty), significant heart, metabolic, or kidney problems, long-term steroid or immune-suppressing medication use, active cancer within the past year or requiring chemotherapy, uncontrolled episodes of sudden high blood pressure (autonomic dysreflexia) within the past 3 months, fluid build-up in the brain (hydrocephalus) with or without a shunt, or a medical reason that prevents stopping blood-thinning medication before surgery
• People whose brain scans show features that would make it too difficult or too risky to place the implant in the required locations
• People who are unable to have an MRI scan before the implant is placed — for example because they have other implanted devices that are not MRI-compatible, such as a pacemaker, heart defibrillator, spinal cord or vagal nerve stimulator, deep brain stimulator, or cochlear implant
• People who are expected to need an MRI scan after the study device (called the CortiCom assembly) has been implanted

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