Postoperative Delirium
Conditions
Brief summary
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.
Interventions
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.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of POD after a single cTBS treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of POD after multiple cTBS treatments | 7 days after surgery | No POD was evaluated by CAM at 1 hour after two or three cTBS treatments and at any time point thereafter. |
| Severity of postoperative delirium changed after each cTBS treatment | 7 days after surgery | Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS. |
Countries
China
Outcome results
None listed