Quantitative Neurofeedback Techniques for Treating Perioperative Cognitive Disorders in Elderly Patients

NCT06752148 | Not Yet Recruiting

• 1 other identifier: 2022-JKCS-20
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

perioperative neurocognitive disorder; neurofeedback intervention training; elderly patients; quantitative measurement of brain

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  On postoperative days 1-7, the investigator assessed subjects for CAM daily from 8:00 am-12:00 pm and 14:00 pm-18:00 pm.

  7 days after surgery

Secondary Outcomes (3)

• Number of occurrences of delirium

  7 days after surgery

• Severity of POD

  7 days after surgery

• Type of POD

  7 days after surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

Subjects should undergo at least 2 consecutive weeks of uninterrupted closed-loop neurofeedback training prior to surgery. During the training cycle, subjects can train "Digital Meditation" (15-20 minutes) + "Idea Magic Ball" game (5-15 minutes) at least once a day in the morning and once in the afternoon, and then choose whether or not to play the "Chase Training" and "Concentration Training" games. The "Chase Training" and "Concentration Training" games should be played at your own choice. During the cycle, you need to perform "sleep induction" training once a night before going to bed (20-40 minutes), and complete the cumulative ≥14 hours of training (the length of time recorded by the APP) before the surgery. The total number of hours of training should be ≥14 before the surgery (APP records the number of hours of training).

Combination Product: neurofeedback intervention training game

Control Group

NO INTERVENTION

Control subjects lived a normal life before the operation.

Interventions

neurofeedback intervention training game COMBINATION_PRODUCT

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing elective major surgery (colorectal, pancreatic-gastric, hepatobiliary, thoracic, gynaecological and urological) under general anaesthesia;
• Expected duration of surgery \>2 hours;
• Age ≥65 years;

You may not qualify if:

• refused to participate in this study;
• preoperative MMSE score \<26 or if the patient's educational level was lower than high school, MMSE \<24 and active depressive state (GDS-15 score \>9);
• underwent neurosurgery or the surgery itself interfered with the patient's postoperative communicative communication (e.g., tracheotomy);
• severe organ dysfunction;
• underwent cardiac surgery, (e) Undergoing cardiac surgery, neurosurgery, or neurosurgery;
• ASA classification IV or higher.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Hui Zheng, MD

  National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, MD

CONTACT

17801011728; evelin0114@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medical staff and outcome assessors were blinded to the fact that volunteers were responsible for obtaining the randomisation number, preparing the intervention equipment, and training in its use, and that patient follow-up, and assessment of relevant outcomes, were carried out by a trained investigator (anaesthetist), who was not involved in anaesthesia or perioperative management; medical staff and other investigators, except volunteers, were not aware of the subgroups; and the study was not blinded to the subjects.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects should undergo at least 2 consecutive weeks of uninterrupted closed-loop neurofeedback training prior to surgery. During the training cycle, subjects can train "Digital Meditation" (15-20 minutes) + "Idea Magic Ball" game (5-15 minutes) at least once a day in the morning and once in the afternoon, and then choose whether or not to play the "Chase Training" and "Concentration Training" games. The "Chase Training" and "Concentration Training" games should be played at your own choice. During the cycle, you need to perform "sleep induction" training once a night before going to bed (20-40 minutes), and complete the cumulative ≥14 hours of training (the length of time recorded by the APP) before the surgery. The total number of hours of training should be ≥14 before the surgery (APP records the number of hours of training).

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share