MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Launched by NADER POURATIAN · Jul 3, 2023
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The MindEx trial is a research study aimed at developing a new technology called a brain-computer interface (BCI) that helps people with severe paralysis control computers just by thinking. This innovative system, named MindEx, uses four tiny chips implanted in the brain to read brain activity and translate those thoughts into actions on a computer, laptop, or tablet. This means that individuals who are unable to move can interact with technology in a more natural and effective way, potentially improving their independence and quality of life.
To participate in the trial, individuals must have paralysis from conditions such as spinal cord injuries, strokes, or ALS, and be able to give informed consent. They should also have a stable support system and be able to travel to study locations several times a week. Participants will be closely monitored and will have the MindEx system implanted for at least a year, during which researchers will assess its safety and effectiveness. This study is not yet recruiting, but it represents an exciting step toward enhancing the lives of those with significant mobility challenges.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)
- • Provide informed consent
- • Understand and comply with instructions, if necessary, with the aid of a translator
- • Communicate via speech or other means
- • Surgical clearance
- • Life expectancy greater than 12 months
- • Travel to study locations up to five days per week for the duration of the study
- • Caregiver monitor for surgical site complications and behavioral changes on a daily basis
- • Psychosocial support system
- • Stable ventilator status
- Exclusion Criteria:
- • Presence of memory problems
- • Intellectual impairment
- • Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- • Poor visual acuity
- • Pregnancy
- • Active infection or unexplained fever
- • Scalp lesions or skin breakdown
- • HIV or AIDS infection
- • Active cancer or chemotherapy
- • Diabetes
- • Autonomic dysreflexia
- • History of seizure
- • Implanted hydrocephalus shunt
- • Prior cranioplasty
- • Other implanted devices
- • Medical conditions contraindicating surgery and chronic implantation of a medical device
- • Unable to undergo MRI or anticipated need for MRI during the study
- • Breastfeeding an infant (direct nursing or via a bottle of expressed milk)
- • Chronic oral or intravenous use of steroids or immunosuppressive therapy
- • Suicidal ideation
- • Drug or alcohol dependence
- • Planning to become pregnant, or unwilling to use adequate birth control
About Nader Pouratian
Nader Pouratian is a distinguished clinical trial sponsor with a focus on advancing innovative therapeutic solutions in the field of neurology and pain management. With a robust background in clinical research and a commitment to improving patient outcomes, Pouratian leads initiatives that bridge scientific discovery and practical application. His work emphasizes the importance of rigorous study design, ethical standards, and collaborative partnerships, aiming to translate cutting-edge research into viable treatment options for patients. Through his leadership, clinical trials under his sponsorship are characterized by their integrity, scientific excellence, and dedication to enhancing quality of life for individuals affected by neurological disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dallas, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported