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Clinical Trials in China / NCT06968039
Recruiting Not applicable

Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients

NCT06968039 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-12-31
Last updated
2025-05-13

Condition(s) studied

Multiple SclerosisElectric Stimulation

Investigational drug(s) / intervention(s)

Neuroelectrics StarStim 32Neuroelectrics StarStim 32

Neuroelectrics StarStim 32: Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal and parietal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session for one time with EEG monitoring conducted before and after electrical stimulation.

Neuroelectrics StarStim 32: Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.

Study summary

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 a one-time tES intervention, measuring changes in cognitive domains including working memory, attention, executive function, and processing speed.

Anticipated Results: We 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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; * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968039 on ClinicalTrials.gov ↗ ← All trials in China