A Study of the Higher Cognitive Functions of the Human Brain With Single-neuron Activity Recording

NCT06408415 | Recruiting

• 1 other identifier: KY2024-638
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate that neural activity of higher cognitve function of human brain with hyperflexible neural electrode-cortex

Conditions

Cognition

Keywords

Electrodes, Implanted; higher cognitive function; single neural activity

Outcome Measures

Primary Outcomes (2)

• recording local field potentiation

  The mechanism of higher cognitive functions will be investigated by analysing characteristics of local field potentiation which is correlated with higher cognitive functions tasks, such as events related potential, information coding, etc.

  through study completion, an average of 2 year

• recording single neural spikes

  The mechanism of higher cognitive functions will be investigated by analysing characteristics of single neural spikes which is correlated with higher cognitive functions tasks, such as firing frequency, events related potential, information coding, etc.

  through study completion, an average of 2 year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients received treatments in Huashan hospital

You may qualify if:

• aged 18-70 years old.
• have selective or confine operation indications:spontaneous basal ganglia hemorrhage or lobar hemorrhage that need catheter aspiration and drainage;hydrocephalus that need V-P shunt; need placing ommaya.
• GCS score 12-15; must be able to communicate with investigators in Mandarin and comply with study requirements.
• volunteered to participate in this study and sign informed consent.

You may not qualify if:

• have severe cognitive dysfunction.
• have psychiatric disorders, such as depression, anxiety disorders and schizophrenia.
• long-term use of special medications, such as hormones, immunosuppressant, and anticoagulants.
• be allergic to surgery instruments or medications.
• have general anesthesia, surgery contraindications.
• have acute cardiac infarction or heart arrest within 6 months.
• have other neurosurgery contraindications assessed by investigators.
• lactation or pregnancy.
• have serious systemic disease or organ dysfunctions that affects study outcome or visits.
• participate in other ongoing clinical trials.

Sponsors & Collaborators

• Huashan Hospital: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Xuehai Wu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+8613764880571; Wuxuehai2013@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Huashan Hospital

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 10, 2024
• Study Start: June 19, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (1)