Brain Surgery, Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe
Conditions
Keywords
First-in-human, Brain-Computer Interface
Brief summary
The goal of this interventional study is to find out the feasibility of whether the soft neural probe can be used in human brain tissue. The main questions it aims to answer are: * Are there any problems when inserting the soft neural probe into brain tissue? * Can the soft neural probe record electrical signals from the brain tissue? Participants will: * During their already scheduled brain tumor or epileptic tissue removal, have the soft neural probe inserted into the section of brain tissue that is due to be removed * Visit the clinic for follow up after 30 days for checkups
Interventions
DEVICESoft Neural Probe
sub-acute insertion of the soft neural probe with neural signal recording
Sponsors
Axoft, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Participants undergoing brain resection due to tumor or epilepsy
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-80 years of age at the time of providing informed consent * Capable of providing written informed consent to participate * Willing to commit to the study evaluations and visit schedule * Undergoing a planned surgery for brain tissue resection of either a tumor or of a epileptogenic lesion * Adequate hepatic, renal, cardiac, and hematologic function according to the following laboratory test criteria: * Absolute neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * Signs of previous or current ischemic cardiac disease or arrhythmia per electrocardiogram assessment * Females of childbearing potential must have a negative serum pregnancy test and agree to use birth control measures during study treatment and for 3 months after its completion * Must not be pregnant or nursing at study entry * Women/men of reproductive potential must have agreed to use an effective contraceptive method
Exclusion criteria
* Substance abuse, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) * Allergy to any study materials * Presence of any powered implantable medical device or any medical device implanted in the brain * Weakened immune system due to presence of poorly controlled chronic diseases such as human immunodeficiency virus (seropositive for HIV 1 or 2), decompensated diabetes, decompensated chronic kidney disease, decompensated liver disease, intake of immunosuppressive medications such as high-dose corticosteroids, or a previous diagnosis of congenital or acquired immunodeficiency * Exposure to any type of chemotherapy in the past 3 months * Radiation therapy in the surgical area within the last year * Delay to the base operation creates additional risk for the patient due to uncontrolled elevated ICP or emergency surgery * Active infection, bleeding, or hematoma * Patients with previous resection surgery in the planned surgical area * Previous stroke in the affected tissue * Currently high levels of inflammation as indicated by ESR, CRP, or PCT blood test * Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, or active systemic infection) that is likely to interfere with study procedures. * Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to the planned neurosurgical intervention. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to the planned neurosurgical intervention are acceptable. * Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. * Any other psychological, family or geographic problem that may make compliance with the study protocol difficult. * Life expectancy of less than 3 months. * Major surgery within 4 weeks prior to planned neurosurgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed by adverse events | From surgery to 30-day follow up | Assessed by enumerating reported adverse events occurring from use of the study device during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed by use | From the introduction of the soft neural probe into the surgery field until 20 minutes later | Assessed by average of Net Promoter Score |
| Local tissue effect biocompatibility via measurement of area of affected tissue | Histopathology conducted within 3 months following tissue resection | Histopathological evaluation of the resected tissue including the insertion track of the soft neural probe. Area of tissue damaged as defined by H&E staining |
| Number of Participants where Neural Signals are Recorded from the Soft Neural Probe | From the introduction of the soft neural probe into the surgery field until 20 minutes later | — |
Countries
Panama
Outcome results
None listed