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 who are able to give their informed consent to take part, as judged by the study doctors
• People who have been diagnosed with amyotrophic lateral sclerosis (ALS) or motor neuron disease (MND), with weakness in both arms
• People aged 18 years or older
• People whose life expectancy is greater than 12 months after the device is implanted, as judged by the study doctors
• People whose brain scan (CT) shows a specific brain region (the precentral gyrus) is intact
• People whose blood vessel structure in the brain is suitable for the procedure, as assessed by the study doctors using a specialised CT scan
• People whose body has a suitable area under the skin where part of the device can be placed
• People who are able to safely undergo general anaesthesia
• People who are willing and able to attend clinic visits and take part in training sessions at home as required by the study
• People who have a carer who is willing and able to help attend study visits and assist with the device outside of study visits (such as keeping it charged)
• People who, along with their carer, are fluent in English
• People who have a suitable home environment for device training, including a working internet connection

Who may not be able to join:

• People whose expectations about what the device can do are considered unrealistic by the study doctors
• People who have an active infection or unexplained fever in the 48 hours before giving consent to participate
• People who have a significant psychiatric condition that may affect their safety or ability to follow study requirements, such as severe depression, psychosis, personality disorder, severe emotional instability, or substance abuse, as judged by the study doctors
• People who have dementia or cognitive difficulties that would affect their ability to take part in study activities, as judged by the study doctors
• People who already have an active implanted device, such as a heart pacemaker, deep brain stimulator, cardiac defibrillator, or similar device
• People with a known allergy to the materials used in the implanted device (as listed in the device manual)
• People for whom specialised blood vessel imaging or iodine-based contrast dye used in that imaging is not medically safe
• People with a history of blood clots in the large veins of the brain (central venous sinus thrombosis)
• People who have had a blood clot in a vein within the past 6 months, or who have a recurring history of venous blood clots
• People for whom blood-thinning medication is not medically safe, as judged by the study doctors
• People who are at significantly higher risk of infection, including those with a weakened immune system, frequent or ongoing infections, or poorly controlled diabetes
• People who are at significant risk of wounds not healing properly, including those with a history of non-healing surgical wounds or poorly controlled diabetes
• People who are currently receiving, or are expected to need, certain medical treatments that may not be compatible with the implanted device — including MRI scans, transcranial magnetic stimulation, electroconvulsive therapy, certain types of ultrasound therapy, or certain procedures involving the blood vessels where the device is placed (confirm with trial site)
• People who are currently pregnant or breastfeeding
• People who are already enrolled in another clinical trial that could interfere with this study's results or requirements
• People whose ALS is caused by a SOD1 gene mutation and who are currently on gene therapy for this
• People with any other condition that the study doctors believe could significantly affect their ability to participate — for example, vision or hearing difficulties that would make it hard to use the brain-computer interface during training and testing

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