Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
• Intervention / Treatment: Device: Neuroelectrics StarStim 32; Device: Neuroelectrics StarStim 32

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junwei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: zhao; Phone Number: 010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Expanded Disability Status Scale (EDSS) score ≤ 6
• Right-handed
• Willing to participate and sign informed consent

Exclusion Criteria:

• 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
• Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
• History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
• Pregnant or breastfeeding women, or those planning to conceive in the near future
• Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
• Presence of severe or unstable organic diseases
• Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
• Any condition deemed unsuitable for study participation by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neuromodulation Group	Device: Neuroelectrics StarStim 32; Using 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.; Device: Neuroelectrics StarStim 32; Sham 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.
Sham Comparator: Sham-Neuromodulation Group	Device: Neuroelectrics StarStim 32; Using 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.; Device: Neuroelectrics StarStim 32; Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 1month
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.	From enrollment to the end of treatment at 1month
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.	From enrollment to the end of treatment at 1month
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.	From enrollment to the end of treatment at 1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 1 month later
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.	From enrollment to 1 month later
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.	From enrollment to 1 month later
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.	From enrollment to 1 month later
MoCA (Montreal Cognitive Assessment)	A screening tool used to detect mild cognitive impairment. It evaluates multiple cognitive domains, including attention, memory, language, and executive function. Range: 0-30 Higher Scores: Indicate better cognitive function, with a score below 26 typically suggesting cognitive impairment. Purpose: Commonly used to assess cognitive function in patients with early dementia, stroke, or neurological disorders.	From enrollment to 1 month later
SDMT (Symbol Digit Modalities Test)	A neuropsychological test assessing processing speed, attention, and visual-motor coordination. It requires the patient to match symbols to digits based on a key. Range: Varies based on time and performance (measured in seconds or correct responses). Higher Scores: Indicate better processing speed and cognitive function. Purpose: Used to assess cognitive performance and processing speed in clinical research and patient assessments.	From enrollment to 1 month later
DST (DigiScan Test)	A neuropsychological test used to evaluate attention and working memory by requiring patients to process and manipulate digital sequences. Range: Dependent on the version of the test used (typically time-based or score-based). Higher Scores: Indicate better cognitive performance, particularly in attention and working memory. Purpose: Assesses cognitive function, often used in the evaluation of neurodegenerative diseases or brain injury.	From enrollment to 1 month later
BVMT (Brief Visuospatial Memory Test)	A test designed to measure visuospatial memory and learning ability, asking patients to remember and recall spatially presented objects. Range: Varies depending on the test format (measured in correct responses or recall time). Higher Scores: Indicate better visuospatial memory performance. Purpose: Used to assess memory, particularly in the context of cognitive disorders like MS and Alzheimer's disease.	From enrollment to 1 month later
NRS (Numerical Rating Scale)	A self-reported scale that asks patients to rate the intensity of their pain on a scale from 0 to 10. Range: 0-10 Higher Scores: Indicate more intense pain. Purpose: Commonly used in clinical practice to measure pain intensity and assess treatment efficacy.	From enrollment to 1 month later
SF-MPQ (Short-Form McGill Pain Questionnaire)	A self-reported questionnaire used to assess the quality and intensity of pain, measuring sensory, affective, and evaluative dimensions of pain. Range: 0-78 (higher scores indicate greater pain severity) Higher Scores: Indicate greater pain intensity and distress. Purpose: Often used to assess pain in clinical and research settings, providing both quantitative and qualitative measures of pain.	From enrollment to 1 month later
ESS (Epworth Sleepiness Scale)	A self-report questionnaire used to assess daytime sleepiness and the likelihood of falling asleep in various situations. Range: 0-24 Higher Scores: Indicate higher levels of daytime sleepiness. Purpose: Used to assess sleepiness, often in the context of sleep disorders like sleep apnea or narcolepsy.	From enrollment to 1 month later
Ashworth Scale	A clinician-administered scale used to measure muscle spasticity. It evaluates the resistance of a muscle to passive movement in response to varying speeds. Range: 0-4 Higher Scores: Indicate greater spasticity, with 0 being no spasticity and 4 being severe spasticity. Purpose: Commonly used in neurological conditions such as cerebral palsy, multiple sclerosis, and stroke.	From enrollment to 1 month later
SF-36 (Short Form 36 Health Survey)	A self-reported health survey designed to measure quality of life, including physical, emotional, and social well-being. It consists of 36 questions grouped into eight domains. Range: 0-100 for each domain (higher scores indicate better health status). Higher Scores: Indicate better health and quality of life. Purpose: Used widely to assess general health status, particularly in chronic illness and clinical trials.	From enrollment to 1 month later
CGI-I (Clinical Global Impression - Improvement)	A clinician-administered scale that evaluates the overall improvement of a patient's condition since the initiation of treatment. Range: 1-7 Higher Scores: Indicate less improvement, with a score of 1 indicating "very much improved" and 7 indicating "very much worse." Purpose: Used to assess treatment effectiveness in clinical trials and practice, particularly in psychiatric and neurological conditions.	From enrollment to 1 month later
EGI Recording EEG Data and MRI Data	EEG (Electroencephalography): A technique used to measure electrical activity in the brain. It records brain waves and can help identify abnormalities related to seizures, sleep disorders, or other neurological conditions. MRI (Magnetic Resonance Imaging): A non-invasive imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues. It is commonly used to assess brain structure, identify lesions, and detect abnormalities. Purpose: Both EEG and MRI are used to monitor and assess brain activity and structure in patients, providing valuable insights into neurological conditions and helping in diagnosis and treatment planning.	From enrollment to 1 month later

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases; Demyelinating Diseases
• Other Study ID Numbers: xw-tES-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No