Executive Function DisorderNCT05575583
rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction
A study testing repetitive transcranial magnetic stimulation and pseudo repetitive transcranial magnetic stimulation in people with Executive Function Disorder and Functional Magnetic Resonance Imaging, run by Xuzhou Central Hospital at 1 site in China.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a new neuroelectrophysiological technique developed in recent years. rTMS can affect local and distant cortical function, promote regional reconstruction of cortical function, and has clear curative effect on a variety of neuropsychiatric diseases. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Executive Function Disorder, Functional Magnetic Resonance Imaging
- What is being tested?
- repetitive transcranial magnetic stimulation and pseudo repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 30 Sep 2025
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart valve replacement.
- 45 to 75 years old.
Who cannot join
- definite cerebral infarction.
- failure and decompensation of vital organs
- physical metal implants.
- severe neuropsychiatric disorders.
- less than 9 years of education.
- alcohol abuse.
- drug dependence.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Yangzi Zhu, Doctor, +86 18168779150, zhuyz@168.com
About this study
Official title: Clinical Study of Repeated Transcranial Magnetic Stimulation in the Prevention and Treatment of Postoperative Executive Dysfunction
Repetitive transcranial magnetic stimulation (rTMS) is a new neuroelectrophysiological technique developed in recent years. rTMS can affect local and distant cortical function, promote regional reconstruction of cortical function, and has clear curative effect on a variety of neuropsychiatric diseases. Previous study found that rTMS can improve postoperative cognitive function, and there may be a dual biological mechanism. Brain network abnormalities may be the direct cause of postoperative cognitive dysfunction, and neuroinflammation is one of the key molecular mechanisms behind postoperative cognitive dysfunction . rTMS may play a role in the regulation of brain network and inflammatory molecules, and thus play a role in the prevention and treatment of postoperative cognitive dysfunction (POCD).
Read the detailed description
This study intends to use neuroimaging methods to observe the correlation between neuroinflammation and brain network abnormalities in patients with POCD, and verify the repair effect of rTMS intervention on the pathological changes, so as to provide a theoretical basis for further optimizing the establishment of rTMS localization therapy model for POCD.
- Being tested
- repetitive transcranial magnetic stimulation, pseudo repetitive transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
The neural navigation system was used to accurately locate the stimulus target.Continuous theta short rapid pulse mode was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses.
pseudo repetitive transcranial magnetic stimulationDevice
Participant in control group receive pseudo repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery. The stimulation target area was the posterior cingulate gyrus, and the neuronavigation system was used to accurately locate the stimulation target in this project. Continuous theta short rapid pulse mode (cTBS) was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses. Stimulation sessions are from 8 to 10 a.m. daily. Receives: Device: repetitive transcranial magnetic stimulation |
| Control group | Sham comparator | Subjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery，but the machine does not turn on. Receives: Device: pseudo repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop color words test(SCWT)
The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Measured: Preoperative
Trail making test
Trail Making test (TMT) was used to evaluate the set switching in executive function
Measured: Preoperative
Corsi Block test
The visuospatial working memory of executive function was assessed by the Corsi Block test
Measured: Preoperative
Stroop color words test(SCWT)
The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Measured: Postoperative 1 week
Trail making test
Trail Making test (TMT) was used to evaluate the set switching in executive function
Measured: Postoperative 1 week
Corsi Block test
The visuospatial working memory of executive function was assessed by the Corsi Block test
Measured: Postoperative 1 week
Secondary outcomes (2)
Functional magnetic resonance brain network characteristics
The changes of brain network between intervention group and control group before and after operation were compared. Resting-state fMRI and task-state fMRI were evaluated.
Measured: Preoperative
Functional magnetic resonance brain network characteristics
The changes of brain network between intervention group and control group before and after operation were compared. Resting-state fMRI and task-state fMRI were evaluated.
Measured: Postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start30 Nov 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function DisorderStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Yangzi Zhu, Doctor, Principal investigator, Xuzhou Central HospitalLiwei Wang, Doctor, Study director, Xuzhou Central HospitalQi Yang, Doctor, Study director, Beijing Chao Yang HospitalDaqing Ma, Study chair, Imperial College London, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575583
- Sponsor's protocol ID
- XuzhouCH20221001
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Repeated Transcranial Magnetic Stimulation in the Prevention and Treatment of Postoperative Executive Dysfunction
- ClinicalTrials.gov ID
- NCT05575583
- Acronym / sponsor ID
- XuzhouCH20221001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Oct 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.
Repetitive transcranial magnetic stimulation (rTMS) is a new neuroelectrophysiological technique developed in recent years. rTMS can affect local and distant cortical function, promote regional reconstruction of cortical function, and has clear curative effect on a variety of neuropsychiatric diseases. Previous study found that rTMS can improve postoperative cognitive function, and there may be a dual biological mechanism. Brain network abnormalities may be the direct cause of postoperative cognitive dysfunction, and neuroinflammation is one of the key molecular mechanisms behind postoperative cognitive dysfunction . rTMS may play a role in the regulation of brain network and inflammatory molecules, and thus play a role in the prevention and treatment of postoperative cognitive dysfunction (POCD).
Detailed description
This study intends to use neuroimaging methods to observe the correlation between neuroinflammation and brain network abnormalities in patients with POCD, and verify the repair effect of rTMS intervention on the pathological changes, so as to provide a theoretical basis for further optimizing the establishment of rTMS localization therapy model for POCD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: repetitive transcranial magnetic stimulationSubjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery. The stimulation target area was the posterior cingulate gyrus, and the neuronavigation system was used to accurately locate the stimulation target in this project. Continuous theta short rapid pulse mode (cTBS) was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses. Stimulation sessions are from 8 to 10 a.m. daily. |
| Control group | Sham comparator | Device: pseudo repetitive transcranial magnetic stimulationSubjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery，but the machine does not turn on. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart valve replacement.
- 45 to 75 years old.
Key exclusion criteria (7 listed)
- definite cerebral infarction.
- failure and decompensation of vital organs
- physical metal implants.
- severe neuropsychiatric disorders.
- less than 9 years of education.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationThe neural navigation system was used to accurately locate the stimulus target.Continuous theta short rapid pulse mode was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses. | Device | Intervention group |
| pseudo repetitive transcranial magnetic stimulationParticipant in control group receive pseudo repetitive transcranial magnetic stimulation | Device | Control group |
Primary outcome
Stroop color words test(SCWT)
Time frame: Preoperative
The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Trail making test
Time frame: Preoperative
Trail Making test (TMT) was used to evaluate the set switching in executive function
Corsi Block test
Time frame: Preoperative
The visuospatial working memory of executive function was assessed by the Corsi Block test
Stroop color words test(SCWT)
Time frame: Postoperative 1 week
The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Trail making test
Time frame: Postoperative 1 week
Trail Making test (TMT) was used to evaluate the set switching in executive function
Corsi Block test
Time frame: Postoperative 1 week
The visuospatial working memory of executive function was assessed by the Corsi Block test
2 secondary outcomes
Functional magnetic resonance brain network characteristics
Time frame: Preoperative
Functional magnetic resonance brain network characteristics
Time frame: Postoperative 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- 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.
Yangzi Zhu, Doctor principal investigator
Xuzhou Central Hospital
Liwei Wang, Doctor study director
Xuzhou Central Hospital
Qi Yang, Doctor study director
Beijing Chao Yang 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 repetitive transcranial magnetic stimulation and pseudo repetitive transcranial magnetic stimulation in people with Executive Function Disorder and Functional Magnetic Resonance Imaging, run by Xuzhou Central 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 2 inclusion and 7 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 8 Mar 2023. 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. Some participants in this study may receive a placebo. 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 Liwei Wang, Doctor (+86 18952170255, doctorlww@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop color words test(SCWT) (time frame: Preoperative). The study lists 6 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 8 Mar 2023.