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Completed

NCT Number: NCT05239897

Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji hospital, School of medicine, Shanghai Jiaotong University

Pudong, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Cure rate of POD after multiple cTBS treatments

    Time frame: 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.

  2. Severity of postoperative delirium changed after each cTBS treatment

    Time frame: 7 days after surgery

    Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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