First-In-human Trial of a NovEl Soft and Stretchable Neural probE

Launched by AXOFT, INC. · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new, soft and flexible device called a neural probe that can be gently placed into the brain to record electrical signals. The main goal is to see if it’s safe and possible to insert this soft probe into human brain tissue, and whether it can successfully pick up brain activity. This is being done during planned brain surgeries, such as for removing tumors or areas causing epilepsy, so no extra surgery is needed just for the study.

Adults between 18 and 80 years old who are already scheduled for brain surgery to remove a tumor or epileptic tissue may be eligible if they are healthy enough to participate and can give written permission. During the surgery, the soft probe will be placed into the part of the brain that will be removed, and then participants will return for a follow-up visit about a month later to check on their recovery. The study excludes people with certain health problems, infections, or other conditions that might affect safety or the results. Overall, this trial aims to explore a promising new tool that could help doctors better understand brain activity with less risk during brain procedures.

Gender

ALL

Eligibility criteria

• • 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