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

NCT07029386 | Recruiting

• 1 other identifier: xw-tES-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Outcome Measures

Primary Outcomes (1)

• Cognitive Assessments

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

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

Secondary Outcomes (3)

• SDMT

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

• Improvement in EEG Parameters

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

• Improvement in fMRI Parameters

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

Study Arms (2)

Neuromodulation Group

ACTIVE COMPARATOR

Device: tES

sham Neuromodulation Group

SHAM COMPARATOR

Device: tES

Interventions

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

Neuromodulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Central Study Contacts

Jun wei Hao,MD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: June 19, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)