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

Cognition Clinical Trial

Official title:

A Study of the Higher Cognitive Functions of the Human Brain Based on the Use of Hyperflexible Neural Electrode-cortex for Single-neuron Activity Recording

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408415
• Other study ID #: KY2024-638
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Huashan Hospital
• Contact: Xuehai Wu, Ph.D.
• Phone: +8613764880571
• Email: Wuxuehai2013[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition

Locations

Country	Name	City	State
China	Department of Neurosurgery, Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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