CognitionNCT06408415
A Study of the Higher Cognitive Functions of the Human Brain With Single-neuron Activity Recording
An observational study of Cognition, run by Huashan Hospital at 1 site in China.
Trial summary
This study aims to investigate that neural activity of higher cognitve function of human brain with hyperflexible neural electrode-cortex Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cognition
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: patients received treatments in Huashan hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xuehai Wu, Ph.D., +8613764880571, wuxuehai2013@163.com
About this study
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
This study aims to investigate that neural activity of higher cognitve function of human brain with hyperflexible neural electrode-cortex
Read the 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.
- Conditions
- Cognition
- Keywords
- Electrodes, Implanted, higher cognitive function, single neural activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start19 Jun 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Xuehai Wu, Huashan Hospital
- Investigators
- Xuehai Wu, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408415
- Sponsor's protocol ID
- KY2024-638
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06408415
- Acronym / sponsor ID
- KY2024-638
- Conditions
- Cognition
- Keywords
- Electrodes, Implanted, higher cognitive function, single neural activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients received treatments in Huashan hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuehai Wu, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehai Wu, Ph.D. (+8613764880571, Wuxuehai2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recording local field potentiation (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.