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

July 20, 2024 updated by: Xuehai Wu, Huashan Hospital

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Department of Neurosurgery, Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients received treatments in Huashan hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recording local field potentiation
Time Frame: 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.
through study completion, an average of 2 year
recording single neural spikes
Time Frame: 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.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

Chinese Academy of Sciences

Investigators

  • Principal Investigator: Xuehai Wu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY2024-638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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