Clinical trial NCT05936619: MindEx: a Novel, Multifocal, Cognitive Brain-Machine Interface System
Official title: MindEx: a Novel, Multifocal, Cognitive Brain-Machine Interface System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Paralysis; Quadriplegic
Keywords: spinal cord injury
brain-computer interface
brain-machine interface
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender). It utilizes four implanted "chips" in the human brain from which investigators can record brain activity during subjects' thoughts and decode meaningful information from this activity to be used as control signals for a computer, a laptop, or a tablet. The use of four brain regions is a significant differentiating feature and scientific innovation of this study over much prior work in this space, that typically derived control signals from one, or sometimes two brain regions. The brain regions to be used here can allow the decode of multiple variables simultaneously, including not just moment-to-moment position, but also high-level goals, intentions, decisions, scene comprehension, and error-related signals involved in natural human behavior. The research is being done through a prospective, longitudinal, single-arm early feasibility study to examine the safety and effectiveness of using MindEx to provide the user an intuitive, efficient, and accurate ability to control multiple applications on a computer interface such as a word processor, a paint application, or to play simple video games. Such versatility could greatly improve the autonomy and quality of life of severely paralyzed individuals. Two subjects will be enrolled, each implanted with MindEx for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.


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

Primary outcomes:
measure: Continuous trajectory decoding
timeFrame: Six years after array implantation
measure: Incidence of intervention-related adverse events
timeFrame: Six years after array implantation
measure: Competency in computer/tablet control
timeFrame: Six years after array implantation
measure: Efficacy of multiple brain regions for neural control over subsets of brain regions
timeFrame: Six years after array implantation
Secondary outcomes:
measure: Change in quality of life
timeFrame: Time Frame: Annually, for six years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References: