Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases

Not Applicable

Recruiting

• Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System; MS (Multiple Sclerosis); NMOSD; Acute Disseminated Encephalomyelitis; Transcranial Alternating Current Stimulation

• Registration Number: NCT07087873
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-30
• Study First Submitted: 2025-06-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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.
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

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China