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

Recruiting

• Conditions: Cognition

• Registration Number: NCT06408415
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Detailed Description

In this study, patients who need intracerebral puncture and indwelling drainage tube, such as intracerebral hemorrhage and hydrocephalus, will be recruited. Before implanting electrodes, patients will be trained to do higher cognitive function tasks.During operation, electrode will be implanted accompanied by placing drainage tube. After operation, patients will perform tasks, while electrophysiological signals will be collected. At the end of study, electrode will be removed.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-10
• Study Start: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. aged 18-70 years old.
2. 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.
3. GCS score 12-15; must be able to communicate with investigators in Mandarin and comply with study requirements.
4. volunteered to participate in this study and sign informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recording single neural spikes	through study completion, an average of 2 year	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.
recording local field potentiation	through study completion, an average of 2 year	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.

Trial Locations

Locations (1)

Department of Neurosurgery, Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China