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:

• You are able to give your agreement (consent) to take part in the study.
• You have been diagnosed with ALS (also known as Lou Gehrig's disease) and have weakness in both arms.
• Your ALS has not responded to treatment and you have had it for at least six months.
• You are 22 years old or older.
• Your doctors expect you to live for more than 12 months after the device is implanted.
• A CT scan shows that a specific area of your brain (involved in movement) is in good enough condition for the study (confirm with trial site).
• A CT scan of your blood vessels shows that your anatomy is suitable for the procedure (confirm with trial site).
• Your body has a suitable area under the skin where a small device pouch can be created (confirm with trial site).
• You are able to safely receive general anesthesia (be put to sleep for a procedure).
• You are willing and able to attend all required clinic visits and training sessions, including some at home.
• You have a caregiver who is willing and able to help with study visits — both at the clinic and at home — and assist with the device outside of visits (such as charging it).
• Both you and your caregiver speak and understand English fluently.
• Your home environment is suitable for brain-computer interface (BCI) training sessions.

Who may not be able to join:

• You have an active infection or an unexplained fever in the 48 hours before signing up for the study.
• You have a significant mental health condition that could affect your safety or ability to follow the study requirements, such as severe depression, psychosis, personality disorder, severe mood instability, or substance misuse.
• You have been diagnosed with ALS combined with dementia (ALS-FTD) or any other form of dementia.
• You already have an active implanted medical device, such as a pacemaker, deep brain stimulator, or similar device.
• You have a known allergy to any of the materials used in the implanted device.
• You cannot have certain types of imaging scans or a specific dye (contrast) used during those scans.
• You have a history of blood clots in the large veins of the brain (central venous sinus thrombosis).
• You have had a blood clot (such as a deep vein thrombosis or pulmonary embolism) in the past six months, have a history of repeated blood clots, or have a condition that makes your blood clot more easily than normal.
• You cannot take blood-thinning medications for any reason.
• You have a significantly increased risk of infection — for example, due to a weakened immune system, frequent or ongoing infections, or poorly controlled diabetes.
• There is a significant risk that a surgical wound on your skin would not heal properly, such as a history of wounds that did not heal or poorly controlled diabetes.
• You are currently pregnant or breastfeeding.
• You are currently enrolled in another clinical trial that could affect the results or requirements of this study.
• You have any other condition that could significantly affect your ability to participate — for example, vision or hearing problems that would make it difficult to use a computer screen or follow spoken instructions during training (confirm with trial site).

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