PD - Parkinson's DiseaseCHAMPIONNCT05550714
Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease
A study testing general anesthesia and Conscious sedation in people with PD - Parkinson's Disease and Dexmedetomidine, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- PD - Parkinson's Disease, Dexmedetomidine, Desflurane
- What is being tested?
- general anesthesia and Conscious sedation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2022to 30 Sep 2024
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.
Who cannot join
- Obstructive sleep apnea;
- BMI > 30kg/m2;
- Estimated difficult airway;
- Severe preoperative anxiety;
- Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)
- A history of allergy to the anaesthetics.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
Read the detailed description
STN-DBS under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. At present, there are some studies on the effects of desflurane on neuronal signal amplitude and discharge characteristics during STN-DBS in PD patients but there is no definite conclusion.
This study compares the influence of MER mapping during STN-DBS and the differences in postoperative clinical outcomes between desflurane general anesthesia and conscious sedation anesthesia to explore alternative anesthesia for DBS in PD patients who cannot tolerate local anesthesia or conscious sedation and to provide feasible anesthesia techniques for the application of MER during DBS under general anesthesia.
This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0), which is used to compare the differences in neuronal electrical activities between conscious sedation and general anesthesia via desflurane groups. The secondary outcomes are the NRMS, length of the subthalamic nucleus, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
- Being tested
- general anesthesia, Conscious sedation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaDrug
The patients did not use any preoperative sedative drugs and were given sufentanil citrate 0.1-0.2 µg/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction. After the patients were unconscious, oral endotracheal intubation was performed. Anesthesiologists should continuously monitor PetCO2 and maintain PetCO2 at 30-35 mmHg. During the operation, patients are treated with remifentanil, cisatracurium, and desflurane inhalation at 0.5-1.0 minimum alveolar concentration (MAC). In the MER process, the desflurane concentration is adjusted to maintain 0.5-0.6 MAC. If the desflurane concentration needs to be adjusted to less than 0.5 MAC during MER for various reasons, remedial measures will be implemented.
Conscious sedationDrug
Also called asleep-awake-asleep anesthesia
A loading dose of DEX 0.5 µg/kg was infused intravenously at a constant speed within 15 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.2-0.5 µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. Maintain the BIS value at 60-80.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Experimental | Not described Receives: Drug: general anesthesia |
| Conscious sedation | Active comparator | Not described Receives: Drug: Conscious sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.
Measured: 1 day (during MER recording)
Secondary outcomes (15)
NRMS and their stratified proportions in the CS and GA groups
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN. We will stratify the mean NRMS of the two groups at the level of 0.5, and calculate the stratified proportions.
Measured: 1 day (during MER recording)
Firing rates
The firing rates will be calculated using customized scripts developed from the Osort toolbox.
Measured: 1 day (during MER recording)
Lengths of STN(mm)
The STN pass length is determined as the distance from entry to exit of the STN based on the significant, clear increase in baseline unit activity and FR changes unique to STN.
Measured: 1 day (during MER recording)
Total electrode path times
Total electrode path times are the total number of paths actually selected, which can be used as an indirect indicator to judge the accuracy of positioning.
Measured: 1 day (during MER recording)
Beta band (13-30 Hz) oscillations calculated by spectrum analysis
Power spectrum will be calculated using a discrete Fourier transform of the sampling windows to allow evaluation of change in oscillatory activity along time. Synchronized beta band (13-30 Hz) oscillations are often observed in the dorsolateral region of the STN of PD patients and are thought to play a role in the disease pathophysiology. The power of beta band will be calculated by averaging the power across the corresponding frequency band.
Measured: 1 day (during MER recording)
Proportion of intraoperative remedial measures implemented
If the characteristic discharge activity of neurons cannot be recovered after maintaining the target anaesthetic concentration during MER, the following procedures should be implemented: ① Reduce the concentration of anaesthetics for a short time and wait for the recovery of electrical signals; ② Readjust the target position; and ③ If the STN cannot be successfully identified by MER, implant electrodes with preoperative imaging localization.
Measured: 1 day (during MER recording)
Duration of operation and MER
The operation time and MER recording time from the start to the end.
Measured: 1 day (during the DBS surgery)
The accuracy of the DBS electrode
The accuracy of the target location is defined by the neurosurgeon's review of the postoperative CT scan.
Measured: Within 24 hours after the operation
Clinical efficacy measured with the improvement of the United Parkinson's Disease Rating Scale (UPDRS)-III (conditions: med on/off, stim on/off)
UPDRS -III is the standard test used by movement disorders neurologists to measure balance impairment in PD.
Measured: 6 months after STN-DBS
Clinical efficacy measured with Levodopa equivalent daily dose (LEDD) reduction
Dopaminergic medication is converted into levodopa equivalent, which is assessed the degree of medication reduction.
Measured: 6 months after STN-DBS
Cognitive function as measured by the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA)
MMSE and MoCA will be used to assess cognitive function
Measured: At baseline and 24 hours, 2 days, 3 days and 6 months after the operation
Quality of life measured with the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
PDQ-39 will be used to assess changes in the quality of life of the patients.
Measured: 6 months after STN-DBS
The incidence of operation-related complications
Second operation, infection, intracranial haemorrhage, etc.
Measured: Up to 6 months after randomization
The incidence of anaesthesia-related adverse events
Nausea, vomiting and intraoperative awareness.
Measured: Up to 3 days after randomization
Surgical experience satisfaction 24 hours after the operation and DBS satisfaction 6 months after the operation evaluated by the seven-point Likert scale
The seven-point Likert scale will be used in the present trial. It is a questionnaire answered by the patient 24 hours after the operation. The scale reported the experience of the patient from very dissatisfied to very satisfied, as graded from 1-7.
Measured: 24 hours after operation for surgical experience satisfaction and 6 months after STN-DBS for DBS satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Oct 2022
- Primary completion26 Mar 2024
- Study completion30 Sep 2024 (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 PD - Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550714
- Sponsor's protocol ID
- xsn20220618
- Acronym
- CHAMPION
- Status last verified
- Jul 2024
- First submitted
- 20 Sep 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xie S, Shi L, Xiong W, Fan Y, Chen L, Li X, Tong Y, Yang A, Meng F, Wang A, Zhang J, Han R. Choice of Anesthesia in Microelectrode Recording-guided Deep Brain Stimulation Surgery for Parkinson's Disease (CHAMPION): A Noninferiority Randomized Controlled Trial. Anesthesiology. 2026 Oct 1;145(4):927-941. doi: 10.1097/ALN.0000000000006133. Epub 2026 May 8.
PubMed 42102350Xie S, Shi L, Xiong W, Chen L, Li X, Tong Y, Yang W, Wang A, Zhang J, Han R. Choice of anaesthesia in microelectrode recording-guided deep-brain stimulation for Parkinson's disease (CHAMPION): study protocol for a single-centre, open-label, non-inferiority randomised controlled trial. BMJ Open. 2023 May 30;13(5):e071726. doi: 10.1136/bmjopen-2023-071726.
PubMed 37253497
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT05550714
- Acronym / sponsor ID
- CHAMPION / xsn20220618
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Sep 2022 (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.
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
Detailed description
STN-DBS under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. At present, there are some studies on the effects of desflurane on neuronal signal amplitude and discharge characteristics during STN-DBS in PD patients but there is no definite conclusion.
This study compares the influence of MER mapping during STN-DBS and the differences in postoperative clinical outcomes between desflurane general anesthesia and conscious sedation anesthesia to explore alternative anesthesia for DBS in PD patients who cannot tolerate local anesthesia or conscious sedation and to provide feasible anesthesia techniques for the application of MER during DBS under general anesthesia.
This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0), which is used to compare the differences in neuronal electrical activities between conscious sedation and general anesthesia via desflurane groups. The secondary outcomes are the NRMS, length of the subthalamic nucleus, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Experimental | Drug: general anesthesia |
| Conscious sedation | Active comparator | Drug: Conscious sedation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.
Key exclusion criteria (6 listed)
- Obstructive sleep apnea;
- BMI > 30kg/m2;
- Estimated difficult airway;
- Severe preoperative anxiety;
- Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)
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 |
|---|---|---|
| general anesthesiaThe patients did not use any preoperative sedative drugs and were given sufentanil citrate 0.1-0.2 µg/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction. After the patients were unconscious, oral endotracheal intubation was performed. Anesthesiologists should continuously monitor PetCO2 and maintain PetCO2 at 30-35 mmHg. During the operation, patients are treated with remifentanil, cisatracurium, and desflurane inhalation at 0.5-1.0 minimum alveolar concentration (MAC). In the MER process, the desflurane concentration is adjusted to maintain 0.5-0.6 MAC. If the desflurane concentration needs to be adjusted to less than 0.5 MAC during MER for various reasons, remedial measures will be implemented. | Drug | General anesthesia |
| Conscious sedationAlso: asleep-awake-asleep anesthesiaA loading dose of DEX 0.5 µg/kg was infused intravenously at a constant speed within 15 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.2-0.5 µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. Maintain the BIS value at 60-80. | Drug | Conscious sedation |
Primary outcome
The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).
Time frame: 1 day (during MER recording)
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.
15 secondary outcomes
NRMS and their stratified proportions in the CS and GA groups
Time frame: 1 day (during MER recording)
Firing rates
Time frame: 1 day (during MER recording)
Lengths of STN(mm)
Time frame: 1 day (during MER recording)
Total electrode path times
Time frame: 1 day (during MER recording)
Beta band (13-30 Hz) oscillations calculated by spectrum analysis
Time frame: 1 day (during MER recording)
Proportion of intraoperative remedial measures implemented
Time frame: 1 day (during MER recording)
Duration of operation and MER
Time frame: 1 day (during the DBS surgery)
The accuracy of the DBS electrode
Time frame: Within 24 hours after the operation
Clinical efficacy measured with the improvement of the United Parkinson's Disease Rating Scale (UPDRS)-III (conditions: med on/off, stim on/off)
Time frame: 6 months after STN-DBS
Clinical efficacy measured with Levodopa equivalent daily dose (LEDD) reduction
Time frame: 6 months after STN-DBS
Cognitive function as measured by the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA)
Time frame: At baseline and 24 hours, 2 days, 3 days and 6 months after the operation
Quality of life measured with the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: 6 months after STN-DBS
The incidence of operation-related complications
Time frame: Up to 6 months after randomization
The incidence of anaesthesia-related adverse events
Time frame: Up to 3 days after randomization
Surgical experience satisfaction 24 hours after the operation and DBS satisfaction 6 months after the operation evaluated by the seven-point Likert scale
Time frame: 24 hours after operation for surgical experience satisfaction and 6 months after STN-DBS for DBS satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 42102350Xie S, Shi L, Xiong W, Fan Y, Chen L, Li X, Tong Y, Yang A, Meng F, Wang A, Zhang J, Han R. Choice of Anesthesia in Microelectrode Recording-guided Deep Brain Stimulation Surgery for Parkinson's Disease (CHAMPION): A Noninferiority Randomized Controlled Trial. Anesthesiology. 2026 Oct 1;145(4):927-941. doi: 10.1097/ALN.0000000000006133. Epub 2026 May 8.
- Derived from this study: PubMed 37253497Xie S, Shi L, Xiong W, Chen L, Li X, Tong Y, Yang W, Wang A, Zhang J, Han R. Choice of anaesthesia in microelectrode recording-guided deep-brain stimulation for Parkinson's disease (CHAMPION): study protocol for a single-centre, open-label, non-inferiority randomised controlled trial. BMJ Open. 2023 May 30;13(5):e071726. doi: 10.1136/bmjopen-2023-071726.
- Individual participant dataSharing planned: Yes
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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.
Ruquan Han, MD, PhD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia and Conscious sedation in people with PD - Parkinson's Disease and Dexmedetomidine, run by Beijing Tiantan 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 1 inclusion and 6 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 1 Aug 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 Ruquan Han, MD, PhD (8610-59976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). (time frame: 1 day (during MER recording)). 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 NCT05550714, 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 1 Aug 2024.