Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
Conditions
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.
Interventions
DEVICEtES
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 multimodal MRI monitoring before and after electrical stimulation
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Auditory Verbal Learning Test (AVLT) Score | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | The Auditory Verbal Learning Test (AVLT) evaluates verbal learning and memory performance. The AVLT consists of multiple components, including immediate recall, delayed recall, and recognition memory. The immediate recall score is obtained from three consecutive learning trials and ranges from 0 to 36. The 5-minute delayed recall score ranges from 0 to 12, and the 20-minute delayed recall score ranges from 0 to 12. The recognition score ranges from 0 to 24 after interference trials. Higher scores indicate better cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting-State Functional MRI Network Connectivity | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in resting-state functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated using resting-state functional MRI to characterize changes in functional interactions associated with the stimulation target. |
| Change in Fractional Anisotropy (FA) | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in fractional anisotropy (FA), a diffusion tensor imaging metric reflecting white matter microstructural integrity, will be assessed before and after treatment. |
| Change in EEG Functional Connectivity | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in EEG functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated across different frequency bands, including delta, theta, alpha, beta, and gamma bands. |
| Change in Mean Diffusivity (MD) | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in mean diffusivity (MD), a diffusion tensor imaging metric reflecting overall water diffusion within white matter tissue, will be assessed before and after treatment. |
| Change in Axial Diffusivity (AD) | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in axial diffusivity (AD), a diffusion tensor imaging metric reflecting diffusion along the principal fiber direction, will be assessed before and after treatment. |
| Change in Radial Diffusivity (RD) | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in radial diffusivity (RD), a diffusion tensor imaging metric reflecting diffusion perpendicular to the principal fiber direction, will be assessed before and after treatment. |
| Change in EEG Power Spectral Density | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | Changes in EEG power spectral density (PSD) will be assessed across delta, theta, alpha, beta, and gamma frequency bands. PSD values will be calculated using spectral analysis and expressed in decibels (dB) after logarithmic transformation. Higher or lower PSD values indicate changes in oscillatory brain activity, and the direction of change will be evaluated statistically. |
| Change in Symbol Digit Modalities Test (SDMT) Score | Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up). | The Symbol Digit Modalities Test (SDMT) assesses information processing speed. The SDMT score ranges from 0 to 110, with higher scores indicating better cognitive performance. |
Countries
China
Contacts
CONTACTJun wei Hao,MD
Outcome results
None listed