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

NCT ID: NCT06408415

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-19

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cognition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xuehai Wu

Professor, Huashan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuehai Wu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Huashan Hospital, Fudan University

Locations

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Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuehai Wu, Ph.D.

Role: CONTACT

+8613764880571

Facility Contacts

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Xuehai Wu, Ph.D.

Role: primary

+8613764880571

Other Identifiers

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KY2024-638

Identifier Type: -

Identifier Source: org_study_id

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