Actively Recruiting
The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases
Led by Xuanwu Hospital, Beijing · Updated on 2025-06-19
85
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function in patients with central nervous system inflammatory demyelinating diseases such as Neuromyelitis Optica Spectrum Disorders and Multiple Sclerosis. These diseases often cause significant cognitive impairment, and this study aims to explore a non-invasive approach to help manage cognitive decline using personalized brain stimulation combined with cognitive training. The study randomly assigns participants to either an active neuromodulation group receiving individualized tES combined with cognitive training or a sham neuromodulation group receiving a placebo-like stimulation that mimics sensations without actual treatment. The active treatment involves about 2mA of current applied for 21 minutes, with EEG and functional MRI scans conducted before and after the stimulation to monitor brain activity. This randomized, triple-blind trial includes cognitive assessments at multiple time points. Participants will undergo standardized cognitive testing before treatment, immediately after the last day of treatment, and again one month later to evaluate changes in memory, attention, executive function, and processing speed. Additional assessments include Symbol Digit Modalities Test (SDMT), EEG, and fMRI measurements at the same intervals. The study also monitors safety and compliance, with the total participation period covering these assessments and follow-up evaluations to understand the impact of the intervention on cognitive function.
CONDITIONS
Brief Title
Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Neuromyelitis Optica Spectrum Disorders, Multiple Sclerosis, or other central nervous system inflammatory demyelinating diseases meeting diagnostic criteria
- SDMT score below 55 or reported subjective cognitive decline
- Age between 18 and 65 years, any gender
- Hamilton Anxiety and Depression Scale scores below 7 for both scales
- No relapse or medication changes within the past month
- Expanded Disability Status Scale (EDSS) score of 6 or less
- Right-handed native Chinese speaker with sufficient education to understand test instructions
- Willingness to participate and signed informed consent
You will not qualify if you...
- Relapse within the past month
- Medication changes within the past month or prior use of modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques
- Participation in other clinical studies within 1 month prior or currently
- Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices
- Skin damage or allergies at electrode placement sites
- History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
- Pregnant, lactating, or planning pregnancy soon
- Scoring 3 or higher on suicide item of HDRS-17 or presence of severe mental illness
- Severe or unstable organic diseases
- Poor compliance preventing cooperation with treatment or data collection
- Other conditions judged inappropriate for study participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 21 minutes per session
Participants receive individualized transcranial electrical stimulation combined with cognitive training or sham stimulation.
Cognitive assessments and brain monitoring before treatment, on the last day of treatment, and one month after treatment
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
J
Jun wei Hao,MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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