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NCT Number: NCT07029386

Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases

Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.

Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.

Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed.

Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.

Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Junwei Hao,MD

CONTACT

[email protected]

01083198277

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
  • Patients with SDMT scores <55 or subjective cognitive decline;
  • Age between 18 and 65 years, gender unrestricted;
  • Hamilton Anxiety and Depression Scale scores <7 points for both scales;
  • No relapse or medication changes in the past month;
  • EDSS (Expanded Disability Status Scale) score ≤6;
  • Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions;
  • Willing to participate and have signed informed consent.-

Exclusion criteria

  • Relapse record within the past month;
  • Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
  • Participating in any other clinical research within 1 month prior to enrollment or currently;
  • Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
  • Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
  • History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
  • Pregnant or lactating women, or those planning pregnancy in the near future;
  • Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;
  • Concurrent severe or unstable organic diseases;
  • Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
  • Other situations deemed inappropriate for study participation by the researchers.

Treatment and study plan

TES

Device

his study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group.

Neuromodulation Group:

Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training

Stimulation parameters:

Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and functional MRI (fMRI) monitoring before and after electrical stimulation

Primary outcomes

  1. Cognitive Assessments

    Time frame: Before treatment, on the last 1 day of treatment, and one month after treatment.

    AVLT, Auditory Verbal Learning Test AVLT score is higher, the better.

Secondary outcomes

  1. SDMT

    Time frame: Before treatment, on the last 1 day of treatment, and one month after treatment

    symbol digit modalities test, SDMT score is higher, the better."

  2. Improvement in EEG Parameters

    Time frame: Before treatment, on the last 1 day of treatment, and one month after treatment

    the power spectral density (PSD) of delta, theta, alpha, beta, and gamma waves; t Default Mode Network (DMN), Sensory Motor Network (SMN), Visual Network (VN), Auditory Network (AN), Cognitive Control Network (CCN), Salience Network (SN), and Dorsal Attention Network (DAN); the intranetwork connectivity within these networks; and the internetwork connectivity between these networks.

  3. Improvement in fMRI Parameters

    Time frame: Before treatment, on the last 1 day of treatment, and one month after treatment

    Default Mode Network (DMN), Sensory Motor Network (SMN), Visual Network (VN), Auditory Network (AN), Cognitive Control Network (CCN), Salience Network (SN), and Dorsal Attention Network (DAN); the intranetwork connectivity within these networks; and the internetwork connectivity between these networks.

Study contacts

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

Jun wei Hao,MD

CONTACT

[email protected]

01083198277

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Jun 19, 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.

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