This project consists of two randomized parallel - group experiments targeting older adults with schizophrenia, aiming to evaluate the therapeutic effect of Peripheral Magnetic Stimulation (PMS).
Experiment 1 (Efficacy of PMS): During a 4 - week intervention period, participants are randomly assigned to receive active PMS or sham PMS. The primary objective is to determine whether PMS can reduce the clinical symptom burden and improve biopsychosocial functioning compared with sham stimulation through electroencephalogram (EEG) signal acquisition and evaluation. Secondary objectives include the effects on cognition, mood, sleep, and health - related quality of life, as well as safety and tolerability (adverse events monitoring).
Experiment 2 (Comparison of Intervention Effects): The subjects are randomly divided into three groups: exercise combined with PMS group, PMS alone group, and exercise alone group. Each group is arranged by relevant professionals to carry out the corresponding intervention for 4 weeks. The main purpose is to examine the differences in the effects of the three intervention methods (exercise combined with PMS, PMS alone, and exercise alone) in improving patients' conditions, including the impact on exercise - related physical performance, functional mobility, etc. Secondary objectives include the impact on overall function and quality of life, along with safety monitoring.
In both experiments, outcome indicators are measured from baseline to post - intervention (and, where feasible, short - term follow - up) by assessors who are blinded to group allocation using appropriate tools. It is hypothesized that in Experiment 1, PMS will be superior to sham stimulation; in Experiment 2, the effect of exercise combined with PMS in improving patients' motor and related functions will be better than that of PMS alone or exercise alone, which supports PMS as a scalable auxiliary means for the rehabilitation of this population.
Participants must be aged ≥60 years.
Diagnosis of schizophrenia based on the International Classification of Diseases - 10th Edition (ICD-10) or Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5).
Diagnosis must be made for ≥6 months, with clinical manifestations of schizophrenia (e.g., hallucinations, delusions, thought disorder, etc.).
No history of severe acute psychiatric episodes or hospitalizations within the last 3 months prior to enrollment.
Schizoaffective disorder or bipolar disorder with psychosis.
Elderly individuals with multiple chronic diseases but who still maintain good functional status and quality of life.
Presence of severe cardiovascular diseases, liver or kidney dysfunction, cerebrovascular diseases, or other physical conditions that may affect treatment.
Patients with contraindications to peripheral magnetic stimulation (PMS) treatment or EEG.
Parallel
Peripheral Magnetic Stimulation (PMS)
DeviceTreatment will be administered using a Peripheral Magnetic Stimulation (PMS) device. The intervention involves directing magnetic fields to stimulate specific peripheral nerve regions to regulate neural activity and improve symptoms.
ham control group receiving PMS intervention
DeviceIdentical to the experimental group in all procedures, except that no electrical stimulation is delivered.
Exercise
Other interventionSee previous sections
PMS＋Exercise
Other interventionSee previous sections
Positive and Negative Syndrome Scale (PANSS) score
Positive and Negative Syndrome Scale (PANSS) Score Description: A 30-item scale assessing positive symptoms, negative symptoms, and general symptoms. Unit of Measure: Score (range 30-210)
resting-state electroencephalography (resting-state EEG)
Resting-State Electroencephalography (EEG) Description: EEG data collection and analysis, including 5-band power (δ, θ, α, β, γ) and brain connectivity. Unit of Measure: Microvolts squared per Hertz (μV²/Hz) for power bands, correlation coefficient for brain connectivity.
6-minute walk test
6-Minute Walk Test (6MWT) Description: A standardized test measuring the distance walked in 6 minutes. Unit of Measure: Distance (meters)
muscle mass index
Muscle Mass Index (using Palm-Held Ultrasound) Description: Measurement of muscle thickness and echo intensity at specific muscle sites. Unit of Measure: Muscle Thickness (millimeters, mm) Echo Intensity (decibels, dB)
Sit-to-Stand Test
Sit-to-Stand Test Description: Time to complete 5 sit-to-stand repetitions and the number of repetitions in 1 minute. Unit of Measure: Time (seconds) for 5 repetitions Repetitions per minute
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Yuntong Zhang
Lead sponsor
Shanghai University of Medicine and Health Sciences
Sponsor institution
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