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

NCT ID: NCT07029386

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• 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 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

Study Design

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

Study Groups

Neuromodulation Group

Group Type: ACTIVE_COMPARATOR

tES

Intervention Type: 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

sham Neuromodulation Group

Group Type: SHAM_COMPARATOR

tES

Intervention Type: DEVICE

Use the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study

Interventions

tES

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

Intervention Type: DEVICE

tES

Use the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• 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, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun wei Hao,MD

Role: CONTACT

haojunwei@vip.163.com

01083198277

Facility Contacts

Junwei Hao,MD

Role: primary

haojunwei@vip.163.com

01083198277

Other Identifiers

xw-tES-01

Identifier Type: -

Identifier Source: org_study_id