Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
tES
Devicehis 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
tES
DeviceUse 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Neuromodulation GroupActive comparator 1 intervention
Group B: sham Neuromodulation GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Auditory Verbal Learning Test (AVLT) Score
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).Secondary outcomes
1
Change in Symbol Digit Modalities Test (SDMT) Score
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).2
Change in EEG Power Spectral Density
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).3
Change in Resting-State Functional MRI Network Connectivity
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).4
Change in Fractional Anisotropy (FA)
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).Sponsors and contacts
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Source ClinicalTrials.gov