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

NCT07087873 | Recruiting

• 1 other identifier: [2025]086-002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Expanded Disability Status Scale, EDSS score

  0-10 points, the higher the score, the more serious

  At the 5-day point of treatment and 1 month following the end of treatment

• Symbol Digit Modalities Test (SDMT) scale

  0-110 points, the higher the score, the better the cognitive function

  At the 5-day point of treatment and 1 month following the end of treatment

• Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog)

  the higher the score, the better the cognitive function

  At the 5-day point of treatment and 1 month following the end of treatment

Secondary Outcomes (6)

• Mini-mental State Examination（MMSE）

  At the 5-day point of treatment and 1 month following the end of treatment

• Montreal-Cognitive Assessment（MoCA）

  At the 5-day point of treatment and 1 month following the end of treatment

• Stroop Color-Word Test score

  At the 5-day point of treatment and 1 month following the end of treatment

• Hamilton Depression Scale，HAMD

  At the 5-day point of treatment and 1 month following the end of treatment

• Hamilton Anxiety Scale，HAMA

  At the 5-day point of treatment and 1 month following the end of treatment

Study Arms (2)

Neuromodulation group

ACTIVE COMPARATOR

Device: Neuroelectrical modulation group

Pseudoneuromodulation group

PLACEBO COMPARATOR

Device: Pseudo-neuromodulation group

Interventions

Neuroelectrical modulation group DEVICE

Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.

Neuromodulation group

Pseudo-neuromodulation group DEVICE

Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.

Pseudoneuromodulation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Encephalomyelitis, Acute Disseminated

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

huang huijin, Ph.D.

CONTACT

+8618510510804; huanghuijinmail@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 28, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)