Acute Disseminated Encephalomyelitis, Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD, Transcranial Alternating Current Stimulation
Conditions
Brief summary
This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.
Interventions
DEVICENeuroelectrical modulation group
Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.
DEVICEPseudo-neuromodulation group
Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-60 years old. * Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria. * Medications have been stable for at least three months.
Exclusion criteria
* Recurrence has been recorded in the past 3 months. * Have a pacemaker or other metal implant in the body. * Impaired skin integrity at the site of electrode placement. * Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection. * Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction. * Pregnant or lactating women, those who are planning to become pregnant in the near future. * Patient compliance is poor. * In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale, EDSS score | At the 5-day point of treatment and 1 month following the end of treatment | 0-10 points, the higher the score, the more serious |
| Symbol Digit Modalities Test (SDMT) scale | At the 5-day point of treatment and 1 month following the end of treatment | 0-110 points, the higher the score, the better the cognitive function |
| Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog) | At the 5-day point of treatment and 1 month following the end of treatment | the higher the score, the better the cognitive function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale，HAMD | At the 5-day point of treatment and 1 month following the end of treatment | The higher the score, the worse the depression. |
| Mini-mental State Examination（MMSE） | At the 5-day point of treatment and 1 month following the end of treatment | 0-30，the higher the score, the better the cognitive function |
| a subjective questionnaire，adverse effects | Following the first day of treatment，Following the second day of treatment，Following the third day of treatment，Following the fourth day of treatment，Following the fifth day of treatment | The intensity is scored from 0 to 4 |
| Hamilton Anxiety Scale，HAMA | At the 5-day point of treatment and 1 month following the end of treatment | The higher the score, the worse the anxiety. |
| Montreal-Cognitive Assessment（MoCA） | At the 5-day point of treatment and 1 month following the end of treatment | 0-30，the higher the score, the better the cognitive function |
| Stroop Color-Word Test score | At the 5-day point of treatment and 1 month following the end of treatment | the higher the score, the better the cognitive function |
Countries
China
Contacts
Primary Contacthuang huijin, Ph.D.
Outcome results
None listed