Deep Brain Stimulation SurgeryNCT06400901
Analysis of Deep Brain Nuclei LFP and Cortical EEG Signals During the Recovery From General Anesthesia
An observational study of Deep Brain Stimulation Surgery and Electrophysiology, run by Ruijin Hospital at 1 site in China.
Trial summary
The correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. In this study, the local field potential (LFP) from the deep brain nuclei and the scalp electroencephalogram (EEG) of the frontal cortex were recorded from patients undergoing deep brain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Brain Stimulation Surgery, Electrophysiology, General Anesthesia
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 15 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the surgical indications and voluntarily undergo DBS surgery at the Functional Neurosurgery Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 2024 until October 2026.
Who may be able to join
- 18-75 years old
- ASA (American Society of Anesthesiologists) classification I-III
- Those who meet the indications for DBS surgery
- Right-handed with normal listening and speaking abilities
- The patient signs the informed consent form and cooperates with the researchers
Who cannot join
- Patients with cognitive impairment [Montreal Cognitive Assessment (MoCA) score less than 26 points];
- Patients with severe depression [Beck Depression Inventory (BDI-II) score greater than or equal to 25 points];
- Patients with important organs dysfunction, such as heart, lungs, liver, and kidneys; or patients with unstable vital signs;
- Patients who are expected to enter the ICU after surgery;
- Patients who are alcoholic, alcohol dependent or drug dependent;
- Patients who have received general anesthesia one month before surgery, patients who are known to be allergic to general anesthetics;
- The DBS surgery exceeds 4 hours;
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 20025
Xin Ma, MD, 021-64370045 ext. 666325
About this study
Official title: Electrophysiology Based Brain Network Study on Deep Brain Nuclei LFP and Cortical EEG During the Recovery From General Anesthesia
The correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. In this study, the local field potential (LFP) from the deep brain nuclei and the scalp electroencephalogram (EEG) of the frontal cortex were recorded from patients undergoing deep brain stimulation (DBS) surgery during the recovery from general anesthesia, in order to explore the changes and relevance of deep brain nuclei firing and cortex activity during the recovery of consciousness from general anesthesia .
Read the detailed description
The recovery of consciousness during the emergence from general anesthesia is an important part of general anesthesia. Previous studies have found that the recovery of consciousness is not a passive process of drug metabolism, but involves the activation of functional neural networks in the brain. However, the temporal-spatial dynamics of different brain regions, including deep brain nuclei and the cortex, during recovery from general anesthesia have not been elucidated.
At present, thanks to the perceptible function of the new generation of deep brain stimulation (DBS) equipment, the local field potential (LFP) of deep brain nuclei can be recorded in real time during the patient's recovery from general anesthesia after DBS surgery. This study will simultaneously record the electrophysiological signals of the patient's deep brain nuclei LFP and cortical EEG signals, and analyze the differences and correlations between the deep brain nuclei LFP and the cortical EEG characteristics during recovery from general anesthesia. This provides evidence for understanding how subcortical deep brain nuclei are involved in the recovery of general anesthesia, and provides clues for solving the mystery of consciousness.
- Conditions
- Deep Brain Stimulation Surgery, Electrophysiology, General Anesthesia, Consciousness, Loss of
- Being tested
- No interventions
- Keywords
- cortex EEG, deep brain nuclei, local field potentiation, propofol
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions were given to patients except for the deep brain stimulation surgery they originally planned to take
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in the Local Field Potential from the Deep Brain Nuclei and the Scalp Electroencephalogram of the Frontal Cortex.
Number of participants with changes in the local field potential from the deep brain nuclei and the scalp electroencephalogram of the frontal cortex during recovery of consciousness from general anesthesia. The recovery of consciousness is defined as the patient can follow the experimenter's verbal command to open mouth and extubate the endotracheal tube.
Measured: 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Brain Stimulation SurgeryStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Ma, MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400901
- Sponsor's protocol ID
- 2023(426)
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Hu K, Green AL, Ma X, Gillies MJ, Wang S, Fitzgerald JJ, Pan Y, Martin S, Huang P, Zhan S, Li D, Tan H, Aziz TZ, Sun B. Dynamic changes in rhythmic and arrhythmic neural signatures in the subthalamic nucleus induced by anaesthesia and tracheal intubation. Br J Anaesth. 2020 Jul;125(1):67-76. doi: 10.1016/j.bja.2020.03.014. Epub 2020 Apr 24.
PubMed 32336475Huang Z, Vlisides PE, Tarnal VC, Janke EL, Keefe KM, Collins MM, McKinney AM, Picton P, Harris RE, Mashour GA, Hudetz AG. Brain imaging reveals covert consciousness during behavioral unresponsiveness induced by propofol. Sci Rep. 2018 Sep 4;8(1):13195. doi: 10.1038/s41598-018-31436-z.
PubMed 30181567
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiology Based Brain Network Study on Deep Brain Nuclei LFP and Cortical EEG During the Recovery From General Anesthesia
- ClinicalTrials.gov ID
- NCT06400901
- Acronym / sponsor ID
- 2023(426)
- Conditions
- Deep Brain Stimulation Surgery, Electrophysiology, General Anesthesia, Consciousness, Loss of
- Keywords
- cortex EEG, deep brain nuclei, local field potentiation, propofol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 6 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.
The correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. In this study, the local field potential (LFP) from the deep brain nuclei and the scalp electroencephalogram (EEG) of the frontal cortex were recorded from patients undergoing deep brain stimulation (DBS) surgery during the recovery from general anesthesia, in order to explore the changes and relevance of deep brain nuclei firing and cortex activity during the recovery of consciousness from general anesthesia .
Detailed description
The recovery of consciousness during the emergence from general anesthesia is an important part of general anesthesia. Previous studies have found that the recovery of consciousness is not a passive process of drug metabolism, but involves the activation of functional neural networks in the brain. However, the temporal-spatial dynamics of different brain regions, including deep brain nuclei and the cortex, during recovery from general anesthesia have not been elucidated.
At present, thanks to the perceptible function of the new generation of deep brain stimulation (DBS) equipment, the local field potential (LFP) of deep brain nuclei can be recorded in real time during the patient's recovery from general anesthesia after DBS surgery. This study will simultaneously record the electrophysiological signals of the patient's deep brain nuclei LFP and cortical EEG signals, and analyze the differences and correlations between the deep brain nuclei LFP and the cortical EEG characteristics during recovery from general anesthesia. This provides evidence for understanding how subcortical deep brain nuclei are involved in the recovery of general anesthesia, and provides clues for solving the mystery of consciousness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the surgical indications and voluntarily undergo DBS surgery at the Functional Neurosurgery Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 2024 until October 2026.
Key inclusion criteria (5 listed)
- 18-75 years old
- ASA (American Society of Anesthesiologists) classification I-III
- Those who meet the indications for DBS surgery
- Right-handed with normal listening and speaking abilities
- The patient signs the informed consent form and cooperates with the researchers
Key exclusion criteria (8 listed)
- Patients with cognitive impairment [Montreal Cognitive Assessment (MoCA) score less than 26 points];
- Patients with severe depression [Beck Depression Inventory (BDI-II) score greater than or equal to 25 points];
- Patients with important organs dysfunction, such as heart, lungs, liver, and kidneys; or patients with unstable vital signs;
- Patients who are expected to enter the ICU after surgery;
- Patients who are alcoholic, alcohol dependent or drug dependent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions were given to patients except for the deep brain stimulation surgery they originally planned to take | Other | – |
Primary outcome
Number of Participants With Changes in the Local Field Potential from the Deep Brain Nuclei and the Scalp Electroencephalogram of the Frontal Cortex.
Time frame: 2 hours.
Number of participants with changes in the local field potential from the deep brain nuclei and the scalp electroencephalogram of the frontal cortex during recovery of consciousness from general anesthesia. The recovery of consciousness is defined as the patient can follow the experimenter's verbal command to open mouth and extubate the endotracheal tube.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 32336475Huang Y, Hu K, Green AL, Ma X, Gillies MJ, Wang S, Fitzgerald JJ, Pan Y, Martin S, Huang P, Zhan S, Li D, Tan H, Aziz TZ, Sun B. Dynamic changes in rhythmic and arrhythmic neural signatures in the subthalamic nucleus induced by anaesthesia and tracheal intubation. Br J Anaesth. 2020 Jul;125(1):67-76. doi: 10.1016/j.bja.2020.03.014. Epub 2020 Apr 24.
- Results publication: PubMed 30181567Huang Z, Vlisides PE, Tarnal VC, Janke EL, Keefe KM, Collins MM, McKinney AM, Picton P, Harris RE, Mashour GA, Hudetz AG. Brain imaging reveals covert consciousness during behavioral unresponsiveness induced by propofol. Sci Rep. 2018 Sep 4;8(1):13195. doi: 10.1038/s41598-018-31436-z.
- Individual participant dataSharing planned: No
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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.
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 Deep Brain Stimulation Surgery and Electrophysiology, run by Ruijin 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 5 inclusion and 8 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 13 May 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 Xin Ma, MD (021-64370045 ext. 666325, mx11507@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Changes in the Local Field Potential from the Deep Brain Nuclei and the Scalp Electroencephalogram of the Frontal Cortex. (time frame: 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400901, which also lists 2 linked publications.
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 13 May 2024.