NCT06968039 Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
| NCT ID | NCT06968039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2024-12-31 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 a one-time tES intervention, measuring changes in cognitive domains including working memory, attention, executive function, and processing speed. Anticipated Results: We 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
Inclusion Criteria: * 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; * No relapse or medication changes in the past month; * EDSS (Expanded Disability Status Scale) score ≤6; * Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions; -Willing to participate and have signed informed consent.- Exclusion Criteria: * 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; * Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives; * History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections; * Pregnant or lactating women, or those planning pregnancy in the near future; * Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness; * Concurrent severe or unstable organic diseases; * Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance; * Other situations deemed inappropriate for study participation by the researchers.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06968039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968039 currently recruiting?
Yes, NCT06968039 is actively recruiting participants. Contact the research team at haojunwei@vip.163.com for enrollment information.
Where is the NCT06968039 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06968039 clinical trial?
NCT06968039 is sponsored by Xuanwu Hospital, Beijing. The trial plans to enroll 85 participants.
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