Postoperative DeliriumNCT05239897
Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation
A study testing Continuous theta burst stimulation (cTBS) in people with Postoperative Delirium, run by RenJi Hospital at 1 site in China.
Trial summary
To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Continuous theta burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2022to 15 Mar 2023
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 60 to 80 years;
- Having delirium after elective surgery;
- Being able to complete cognitive assessment and confusion assessment methods (CAM);
- Willing to participate before surgery and being competent to provide informed consent.
Who cannot join
- Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);
- Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);
- Participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji hospital, School of medicine, Shanghai Jiaotong University
Pudong, Shanghai Municipality, 200127
About this study
Official title: Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study
To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.
Read the detailed description
Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS) was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network. Therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether cTBS can cure POD in this senior patient population.
- Conditions
- Postoperative Delirium
- Being tested
- Continuous theta burst stimulation (cTBS)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous theta burst stimulation (cTBS)Device
Patients assessed for postoperative delirium will be treated by consist of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| postoperative delirium | Experimental | We will use Confusion Assessment Method (CAM) to determine the incidence of postoperative delirium in participants twice per day. We will use the Memorial Delirium Assessment Scale(MDAS)and Mini-mental state examination(MMSE) to examine postoperative delirium severity. Receives: Device: Continuous theta burst stimulation (cTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of POD after a single cTBS treatment
No POD was evaluated by CAM at 1 hour after a single cTBS treatment on the day of the first occurrence of POD and at any time point thereafter.
Measured: 7 days after surgery
Secondary outcomes (2)
Cure rate of POD after multiple cTBS treatments
No POD was evaluated by CAM at 1 hour after two or three cTBS treatments and at any time point thereafter.
Measured: 7 days after surgery
Severity of postoperative delirium changed after each cTBS treatment
Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start7 Feb 2022
- Primary completion28 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239897
- Sponsor's protocol ID
- cTBStPOD
- Status last verified
- Nov 2024
- First submitted
- 4 Feb 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study
- ClinicalTrials.gov ID
- NCT05239897
- Acronym / sponsor ID
- cTBStPOD
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 15 Feb 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.
To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.
Detailed description
Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS) was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network. Therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether cTBS can cure POD in this senior patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative delirium | Experimental | Device: Continuous theta burst stimulation (cTBS)We will use Confusion Assessment Method (CAM) to determine the incidence of postoperative delirium in participants twice per day. We will use the Memorial Delirium Assessment Scale(MDAS)and Mini-mental state examination(MMSE) to examine postoperative delirium severity. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 60 to 80 years;
- Having delirium after elective surgery;
- Being able to complete cognitive assessment and confusion assessment methods (CAM);
- Willing to participate before surgery and being competent to provide informed consent.
Key exclusion criteria (3 listed)
- Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);
- Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);
- Participating in other clinical studies.
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 |
|---|---|---|
| Continuous theta burst stimulation (cTBS)Patients assessed for postoperative delirium will be treated by consist of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. | Device | postoperative delirium |
Primary outcome
Cure rate of POD after a single cTBS treatment
Time frame: 7 days after surgery
No POD was evaluated by CAM at 1 hour after a single cTBS treatment on the day of the first occurrence of POD and at any time point thereafter.
2 secondary outcomes
Cure rate of POD after multiple cTBS treatments
Time frame: 7 days after surgery
Severity of postoperative delirium changed after each cTBS treatment
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta burst stimulation (cTBS) in people with Postoperative Delirium, run by RenJi 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of POD after a single cTBS treatment (time frame: 7 days after surgery). 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 18 Nov 2024.