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 agree to take part and give your consent to join the study.
• You have weakness or loss of movement in both arms, or you have ALS (a condition affecting nerve and muscle control) with weakness in both arms.
• Your condition causing the movement difficulty has not improved with treatments and has been present for at least 12 months.
• You are 21 years old or older.
• Your doctor expects you to live for more than 12 months after the device is implanted.
• A scan (CT) shows that a specific part of your brain involved in movement is intact (confirm with trial site).
• A scan of your blood vessels shows that your anatomy is suitable for the device (confirm with trial site).
• Your body has a suitable area under the skin where part of the device can be placed (confirm with trial site).
• You are able to safely have anesthesia (be put to sleep or numbed) for a procedure.
• You are willing and able to attend clinic visits and take part in training sessions at home.
• You have a caregiver who is willing and able to help with study visits and assist with the device outside of visits (for example, charging it).
• Both you and your caregiver can speak and understand English fluently.
• Your home is suitable for brain-computer interface (BCI) training, including having an internet connection.

Who may not be able to join:

• You have unrealistic expectations about what the device might be able to do for you.
• 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 emotional instability, or substance misuse.
• You have dementia or significant memory or thinking difficulties that would make it hard to take part in study activities.
• You already have an implanted electronic device in your body, such as a pacemaker, heart defibrillator, deep brain stimulator, or similar device.
• You have a known allergy to any of the materials used in the implanted device.
• You are unable to have a certain type of medical imaging scan that uses a dye injected into your blood vessels (confirm with trial site).
• You have a history of blood clots in the large veins of your brain.
• You have had a blood clot in a vein in the last 6 months, or you have a history of recurring blood clots in your veins.
• You are unable to take blood-thinning medications (confirm with trial site).
• You have a significantly weakened immune system, get infections frequently, or have poorly controlled diabetes, which could increase your risk of infection.
• There is a significant concern that a wound made under your skin may not heal properly, for example due to a history of non-healing wounds or poorly controlled diabetes.
• You are currently pregnant or breastfeeding.
• You are currently taking part in another clinical trial that could interfere with this study's results or requirements.
• You have any other condition that could significantly affect your ability to take part, for example, vision or hearing difficulties that would make it hard to use a computer screen or follow spoken instructions during training and testing.

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