Xuanwu Hospital, Capital Medical University
Beijing, China
Location status: Recruiting
NCT Number: NCT07029386
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
、
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases
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