Actively Recruiting
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
Led by Huashan Hospital · Updated on 2024-07-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
C
Chinese Academy of Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the higher cognitive functions of the human brain by recording single-neuron activity using a hyperflexible neural electrode-cortex. This study involves patients who need intracerebral puncture and drainage tubes due to conditions like intracerebral hemorrhage or hydrocephalus. The purpose is to investigate neural activity during cognitive tasks using advanced electrodes. Patients will be trained on cognitive tasks before surgery. During the operation, electrodes will be implanted alongside drainage tubes. After surgery, patients will perform cognitive tasks while electrophysiological signals, including local field potentials and single neural spikes, are recorded. At the end of the study, the electrode will be removed. Participants will be assessed through cognitive task performance and electrophysiological recordings over an average of two years. Researchers will monitor neural signals to understand brain function better. Safety and cognitive ability are evaluated, with informed consent required. The total participation time spans from training before surgery to electrode removal after data collection.
CONDITIONS
Brief Title
A Study of the Higher Cognitive Functions of the Human Brain With Single-neuron Activity Recording
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years old
- Have indications for selective or confined operation such as spontaneous basal ganglia hemorrhage or lobar hemorrhage needing catheter aspiration and drainage; hydrocephalus requiring V-P shunt; or need for placing Ommaya reservoir
- Glasgow Coma Scale score between 12 and 15
- Able to communicate in Mandarin and comply with study requirements
- Volunteered to participate and signed informed consent
You will not qualify if you...
- Severe cognitive dysfunction
- Psychiatric disorders such as depression, anxiety disorders, or schizophrenia
- Long-term use of special medications like hormones, immunosuppressants, or anticoagulants
- Allergy to surgical instruments or medications
- Contraindications to general anesthesia or surgery
- Acute cardiac infarction or heart arrest within the last 6 months
- Other neurosurgery contraindications as assessed by investigators
- Pregnancy or breastfeeding
- Serious systemic disease or organ dysfunction affecting study outcome or visits
- Participation in other ongoing clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day prior to surgery
Participants undergo intracerebral puncture and indwelling drainage tube placement as part of their clinical care. Before electrode implantation, participants are trained to perform higher cognitive function tasks.
1 visit (in-person)
Duration - Surgical procedure day
During the operation, a hyperflexible neural electrode is implanted alongside the drainage tube to record single-neuron activity.
1 visit (in-person, surgical)
Duration - Up to 2 years
After surgery, participants perform cognitive tasks while electrophysiological signals are collected. This monitoring continues until the study completion.
Ongoing assessments during hospitalization and follow-up visits
Duration - 1 day for electrode removal
At the end of the study, the implanted electrode is removed during a surgical procedure.
1 visit (in-person, surgical)
Trial Site Locations
Total: 1 location
1
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
X
Xuehai Wu, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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