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

Not Applicable

Recruiting

• Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

• Registration Number: NCT07029386
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-15
• Study First Submitted: 2025-01-19
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2027-07-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive Assessments	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 Outcome Measures

Name	Time	Method
SDMT	Before treatment, on the last 1 day of treatment, and one month after treatment	symbol digit modalities test, SDMT score is higher, the better."
Improvement in EEG Parameters	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.
Improvement in fMRI Parameters	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.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China