This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.
Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
Hamilton Anxiety Scale (HAM-A) score > 14
Aged between 18 and 65 years, with no gender restrictions
Receiving stable doses of immunosuppressive therapy for at least one month
Recorded relapse within the past month
Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
Participation in any other clinical study within the past month or currently
Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
Parallel
Neuroelectrics StarStim 32
DeviceUsing the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.
Neuroelectrics StarStim 32
DeviceSham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.
HAMA (Hamilton Anxiety Rating Scale)
A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms. Range: 0-56 Higher Scores: Indicate more severe anxiety. Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.
HADS (Hospital Anxiety and Depression Scale)
Description: A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression. Range: 0-42 (for each subscale) Higher Scores: Indicate higher levels of anxiety or depression. Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.
SPS (Social Phobia Scale)
A self-report scale used to measure the severity of social anxiety or social phobia. Range: 0-120 Higher Scores: Indicate greater severity of social anxiety. Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.
PSWQ (Penn State Worry Questionnaire)
A self-report scale used to assess the frequency and intensity of a person's worry. Range: 16-80 Higher Scores: Indicate more frequent and intense worry. Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.
EDSS (Expanded Disability Status Scale)
A clinician-administered scale used to measure the severity of disability in patients with multiple sclerosis (MS). It assesses neurological impairment in eight functional systems. Range: 0-10 Higher Scores: Indicate greater disability, with 0 representing normal neurological function and 10 representing death due to MS. Purpose: Used to assess the degree of disability and monitor changes over time in MS patients.
FSS (Fatigue Severity Scale)
A self-report scale designed to assess the impact of fatigue on a patient's daily life. It evaluates the intensity of fatigue in relation to physical activities, work, and social life. Range: 9-63 Higher Scores: Indicate more severe fatigue. Purpose: Used primarily in multiple sclerosis and other neurological disorders to quantify fatigue severity.
HAMD (Hamilton Depression Rating Scale)
A clinician-administered scale used to assess the severity of depression in patients, based on mood, feelings of guilt, and somatic symptoms. Range: 0-52 Higher Scores: Indicate more severe depression. Purpose: Primarily used to assess depression severity in clinical settings and for treatment evaluation.
MMSE (Mini-Mental State Examination)
A brief 30-point test used to screen for cognitive impairment and assess the level of cognitive function in patients, focusing on orientation, memory, and attention. Range: 0-30 Higher Scores: Indicate better cognitive function, with scores below 24 suggesting cognitive impairment. Purpose: Used to assess cognitive function, often in patients with suspected dementia or other cognitive disorders.
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