Investigating brain activity related to higher cognitive functions

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 is testing how brain activity relates to thinking skills in patients who need surgery for conditions like bleeding in the brain or fluid buildup.

Quick facts

• Study type: Observational
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06408415 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the neural activity associated with higher cognitive functions in the human brain using hyperflexible neural electrodes. Patients requiring intracerebral puncture and drainage, such as those with intracerebral hemorrhage or hydrocephalus, will be recruited. Prior to electrode implantation, participants will undergo training on cognitive tasks. During surgery, electrodes will be implanted alongside a drainage tube, and after the procedure, patients will perform tasks while their electrophysiological signals are recorded. The electrodes will be removed at the end of the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with specific surgical indications for intracerebral procedures and a GCS score of 12-15.

Not a fit: Patients with severe cognitive dysfunction, psychiatric disorders, or contraindications to surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of cognitive functions and lead to improved treatments for cognitive impairments.

How similar studies have performed: While studies on neural activity and cognitive functions exist, this specific approach using hyperflexible electrodes is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xuehai Wu, Ph.D. — Department of Neurosurgery, Huashan Hospital, Fudan University
• Study coordinator: Xuehai Wu, Ph.D.

Conditions: Cognition, Electrodes, Implanted, higher cognitive function, single neural activity