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Hyperflexible neural recording electrodes for real-time neural recording and decoding studies in craniotomy under local anesthesia

Hyperflexible neural recording electrodes for real-time neural recording and decoding studies in craniotomy under local anesthesia - An exploratory study on the safety and effectiveness of intracranial hyperflexible neural electrode in stereotactic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085385
Enrollment
Unknown
Registered
2024-06-06
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stereotactic surgery related diseases

Interventions

Test group:In subjects aged 18-75 who need to undergo stereotaxic surgery, hyperflexible microelectrodes are implanted in the brain area at the entry point during the operation, and continuous real-ti

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18-75 years old, regardless of gender; (2) Patients who meet the indications for stereotaxic surgery; (3) The patient can tolerate local anesthesia surgery; (4) The patient has normal cognitive function, good limb function, and can cooperate with the doctor during the operation; (5) Subjects voluntarily participate in the trial and sign informed consent; (6) Those who can communicate well with researchers and comply with trial requirements.

Exclusion criteria

Exclusion criteria: (1) There is obvious cognitive dysfunction; (2) Have severe (refractory) depression, anxiety, schizophrenia and other mental illnesses; (3) Those who take special drugs for a long time, such as immunosuppressants, hormones, anticoagulants, etc.; (4) Those with allergies, history of drug allergy, or allergies to surgical instruments or drugs; (5) There are contraindications for general anesthesia, craniotomy or surgery; (6) Diagnosed with acute myocardial infarction or cardiac arrest within the past 6 months; (7) Patients who have other contraindications to neurosurgery in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Disposable intracranial ultra-flexible microelectrode (HNEC-128 type) detection effectiveness index;

Secondary

MeasureTime frame
Exercise effectiveness indicators;

Countries

China

Contacts

Public ContactZhiqiang Yan

Xijing Hospital

zhiqiangyan-xj@outlook.com+86 136 7925 2326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026