Paralysis; Quadriplegic study: Mind Extender
Official title MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
ClinicalTrials.gov ID: NCT05936619
What this study is testing
- What it's testing
- This study is testing whether MindEx (four tiny brain chips) can let you control a computer with your thoughts.
- Who it's for
- You may be able to join if you have severe paralysis such as quadriplegia or similar conditions.
- What's involved
- You would have four small chips placed in your brain. You would try to move a cursor, type, draw, or play simple games using only your thoughts while researchers watch.
- Time commitment
- The study lasts at least 53 weeks with regular check‑ins, and may continue up to six years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.