Quantitative Neurofeedback Techniques for Treating Perioperative Cognitive Disorders in Elderly Patients
NCT06752148 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390
Last updated 2025-01-08
Summary
The goal of this clinical trial is to learn if quantitative measurement of brain and neurofeedback intervention techniques works to prevent perioperative neurocognitive deficits in elderly oncology patients who are to undergo elective major surgery. The main questions it aims to answer are:
* Can neurofeedback intervention training reduce the incidence of postoperative delirium in elderly oncology patients? Researchers will compare the incidence of postoperative delirium in elderly oncology patients after training in neurofeedback intervention with those after living a normal life, to see if training in neurofeedback intervention before surgery is effective in preventing the development of postoperative delirium.
Participants will:
* Take neurocognitive feedback intervention training for 14 days prior to surgery (recommended to be used for at least 1 hour per day for a cumulative preoperative use of 14 hours).
* Received preoperative and postoperative assessments of cognitive function by a third-party researcher, as well as daily delirium assessments for 7 days postoperatively.
* The subjects in the control group lived a normal life every day before the operation, and the rest of the measures were the same as those in the intervention group.
Conditions
- Emergence Delirium
- Perioperative Neurocognitive Disorder
Interventions
- COMBINATION_PRODUCT
-
neurofeedback intervention training game
1. Issuance of training equipment and training in its use: For subjects randomly assigned to the intervention group, a volunteer who has received adequate training in the use of the equipment will issue the EEG monitoring electrodes (model: HXD-1) and paired PADs, and will provide an activated account for the use of the subject only and training in its use. Subjects will be provided with a short tutorial on how to use the APP, which is very user-friendly and suitable for elderly novices. An initial training session will consist of 3 training components and will be completed with a volunteer. 2. Training programme and supervision: The closed-loop neurofeedback training will consist of 3 parts, namely "Digital Meditation", "Brain Training" and "Sleep Induction". The "brain training" will consist of three games: "Idea Chase", "Idea Magic Ball" and "Focused Archery". The control subjects lived a normal life before the surgery, and all subjects underwent the surgery as planned.
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Hui Zheng, MD · National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-01
- Primary Completion
- 2025-11-30
- Completion
- 2026-12-31
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