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Recruiting NCT07087873

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

No phase Interventional Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System MS (Multiple Sclerosis) NMOSD Acute Disseminated Encephalomyelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuroelectrical modulation group, Pseudo-neuromodulation group.
Who it may be relevant to
Registry conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD, Acute Disseminated Encephalomyelitis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device Neuroelectrical modulation group
    Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.
  • Device Pseudo-neuromodulation group
    Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.

Primary outcome measures

  • Expanded Disability Status Scale, EDSS score [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • Symbol Digit Modalities Test (SDMT) scale [Time frame: 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) [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
Secondary outcome measures (6)
  • Mini-mental State Examination（MMSE） [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • Montreal-Cognitive Assessment（MoCA） [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • Stroop Color-Word Test score [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • Hamilton Depression Scale，HAMD [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • Hamilton Anxiety Scale，HAMA [Time frame: At the 5-day point of treatment and 1 month following the end of treatment]
  • a subjective questionnaire，adverse effects [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07087873 · [2025]086-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗