MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System

Not Applicable

Not yet recruiting

• Conditions: Paralysis; Quadriplegic

• Registration Number: NCT05936619
• Lead Sponsor: Nader Pouratian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Inclusion Criteria:<br><br> - Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke<br> (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)<br><br> - Provide informed consent<br><br> - Understand and comply with instructions, if necessary, with the aid of a translator<br><br> - Communicate via speech or other means<br><br> - Surgical clearance<br><br> - Life expectancy greater than 12 months<br><br> - Travel to study locations up to five days per week for the duration of the study<br><br> - Caregiver monitor for surgical site complications and behavioral changes on a daily<br> basis<br><br> - Psychosocial support system<br><br> - Stable ventilator status<br><br>Exclusion Criteria:<br><br> - Presence of memory problems<br><br> - Intellectual impairment<br><br> - Psychotic illness or chronic psychiatric disorder, including major depression if<br> untreated<br><br> - Poor visual acuity<br><br> - Pregnancy<br><br> - Active infection or unexplained fever<br><br> - Scalp lesions or skin breakdown<br><br> - HIV or AIDS infection<br><br> - Active cancer or chemotherapy<br><br> - Diabetes<br><br> - Autonomic dysreflexia<br><br> - History of seizure<br><br> - Implanted hydrocephalus shunt<br><br> - Prior cranioplasty<br><br> - Other implanted devices<br><br> - Medical conditions contraindicating surgery and chronic implantation of a medical<br> device<br><br> - Unable to undergo MRI or anticipated need for MRI during the study<br><br> - Breastfeeding an infant (direct nursing or via a bottle of expressed milk)<br><br> - Chronic oral or intravenous use of steroids or immunosuppressive therapy<br><br> - Suicidal ideation<br><br> - Drug or alcohol dependence<br><br> - Planning to become pregnant, or unwilling to use adequate birth control

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continuous trajectory decoding;Incidence of intervention-related adverse events;Competency in computer/tablet control;Efficacy of multiple brain regions for neural control over subsets of brain regions

Secondary Outcome Measures

Name	Time	Method
Change in quality of life