Quantitative Neurofeedback Techniques for Treating Perioperative Cognitive Disorders in Elderly Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
7 days after surgery

Secondary outcomes

1

Number of occurrences of delirium

Researchers recorded the number of times subjects experienced delirium in the 7 days following surgery.

Time frame
7 days after surgery
2

Severity of POD

For subjects diagnosed with postoperative delirium within 7 days of surgery, the severity of delirium was assessed using Confusion Assessment Method-Severity Short Form. This scale includes a total of 4 items, with a scoring range of 0-7 points, where 0 points indicate no delirium, 1 point indicates mild delirium, 2 points indicate moderate delirium, and 3-7 points indicate severe delirium.

Time frame
7 days after surgery
3

Type of POD

For subjects diagnosed with postoperative delirium within 7 days after surgery, the type of delirium is determined based on their presentation. Hyperactive delirium is characterized by alertness, agitation, and increased psychomotor activity; hypoactive delirium is characterized by apathy, drowsiness, and reduced psychomotor activity; mixed delirium is characterized by alternating features of hyperactivity and hypoactivity.

Time frame
7 days after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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