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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 multimodal MRI monitoring before and after electrical stimulation

Primary outcomes

  1. Change in Auditory Verbal Learning Test (AVLT) Score

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    The Auditory Verbal Learning Test (AVLT) evaluates verbal learning and memory performance. The AVLT consists of multiple components, including immediate recall, delayed recall, and recognition memory. The immediate recall score is obtained from three consecutive learning trials and ranges from 0 to 36. The 5-minute delayed recall score ranges from 0 to 12, and the 20-minute delayed recall score ranges from 0 to 12. The recognition score ranges from 0 to 24 after interference trials. Higher scores indicate better cognitive performance.

Secondary outcomes

  1. Change in Symbol Digit Modalities Test (SDMT) Score

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    The Symbol Digit Modalities Test (SDMT) assesses information processing speed. The SDMT score ranges from 0 to 110, with higher scores indicating better cognitive performance.

  2. Change in EEG Power Spectral Density

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in EEG power spectral density (PSD) will be assessed across delta, theta, alpha, beta, and gamma frequency bands. PSD values will be calculated using spectral analysis and expressed in decibels (dB) after logarithmic transformation. Higher or lower PSD values indicate changes in oscillatory brain activity, and the direction of change will be evaluated statistically.

  3. Change in Resting-State Functional MRI Network Connectivity

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in resting-state functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated using resting-state functional MRI to characterize changes in functional interactions associated with the stimulation target.

  4. Change in Fractional Anisotropy (FA)

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in fractional anisotropy (FA), a diffusion tensor imaging metric reflecting white matter microstructural integrity, will be assessed before and after treatment.

  5. Change in EEG Functional Connectivity

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in EEG functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated across different frequency bands, including delta, theta, alpha, beta, and gamma bands.

  6. Change in Mean Diffusivity (MD)

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in mean diffusivity (MD), a diffusion tensor imaging metric reflecting overall water diffusion within white matter tissue, will be assessed before and after treatment.

  7. Change in Axial Diffusivity (AD)

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in axial diffusivity (AD), a diffusion tensor imaging metric reflecting diffusion along the principal fiber direction, will be assessed before and after treatment.

  8. Change in Radial Diffusivity (RD)

    Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).

    Changes in radial diffusivity (RD), a diffusion tensor imaging metric reflecting diffusion perpendicular to the principal fiber direction, will be assessed before and after treatment.

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
Aug 19, 2026

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

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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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