Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07087873

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System Acute Disseminated Encephalomyelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis, Acute Disseminated Immune System Diseases Leukoencephalopathies MS (Multiple Sclerosis) Multiple Sclerosis NMOSD Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Transcranial Alternating Current Stimulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Huijin Huang, Ph.D.

CONTACT

[email protected]

18510510804

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuroelectrical modulation group

Device

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

Pseudo-neuromodulation group

Device

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

Primary outcomes

  1. Expanded Disability Status Scale, EDSS score

    Time frame: 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

  2. Symbol Digit Modalities Test (SDMT) scale

    Time frame: 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

  3. 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

    the higher the score, the better the cognitive function

Secondary outcomes

  1. Mini-mental State Examination（MMSE）

    Time frame: 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

  2. Montreal-Cognitive Assessment（MoCA）

    Time frame: 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

  3. Stroop Color-Word Test score

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

    the higher the score, the better the cognitive function

  4. Hamilton Depression Scale，HAMD

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

    The higher the score, the worse the depression.

  5. Hamilton Anxiety Scale，HAMA

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

    The higher the score, the worse the anxiety.

  6. 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

    The intensity is scored from 0 to 4

Study contacts

Contact information is provided by the study sponsor or research team.

huang huijin, Ph.D.

CONTACT

[email protected]

+8618510510804

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Acronym: TACS-CI-IIDDs

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.