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

NCT ID: NCT06968039

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-10-01

Brief 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.

Conditions

Multiple Sclerosis; Electric Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Neuromodulation Group

Group Type: EXPERIMENTAL

Neuroelectrics StarStim 32

Intervention Type: DEVICE

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.

Sham Neuromodulation Group

Group Type: SHAM_COMPARATOR

Neuroelectrics StarStim 32

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun wei Hao, MD

Role: CONTACT

haojunwei@vip.163.com

010+83198277

Facility Contacts

Junwei Hao, MD

Role: primary

haojunwei@vip.163.com

010+83198277

Other Identifiers

xw-tES-04

Identifier Type: -

Identifier Source: org_study_id