Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06408415

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xuehai Wu, Ph.D.

CONTACT

[email protected]

+8613764880571

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuehai Wu, Ph.D.

CONTACT

[email protected]

+8613764880571

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Chinese Academy of Sciences

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.