Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RenJi Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cure rate of POD after a single cTBS treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
postoperative delirium
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.
Intervention: Continuous theta burst stimulation (cTBS) (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Cure rate of POD after multiple cTBS treatments(7 days after surgery)
- Severity of postoperative delirium changed after each cTBS treatment(7 days after surgery)