Clinical trial NCT06968039: Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
Official title: This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Working Memory in Patients With Inflammatory Demyelination of the Central Nervous System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Electric Stimulation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Working Memory Training-Related Scores
timeFrame: An hour before and after interventions
measure: SDMT (Symbol Digit Modalities Test)
timeFrame: An hour before and after interventions.
Secondary outcomes:
measure: AVLT (Auditory Verbal Learning Test)
timeFrame: Before interventions
measure: Digit Span Test
timeFrame: An hour before interventions
measure: BVMTR (Brief Visual Memory Test-Revised)
timeFrame: An hour before and after interventions.
measure: STROOP (Stroop Color and Word Test)
timeFrame: An hour before and after interventions.
Other outcomes:
measure: EDSS (Expanded Disability Status Scale)
timeFrame: At baseline.
measure: MFIS (Modified Fatigue Impact Scale)
timeFrame: At baseline
measure: MSIS (Multiple Sclerosis Impact Scale)
timeFrame: At baseline
measure: HAMA (Hamilton Anxiety Rating Scale)
timeFrame: At baseline
measure: HAMD (Hamilton Depression Rating Scale)
timeFrame: At baseline
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: