Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
- Conditions
- Multiple SclerosisElectric Stimulation
- Registration Number
- NCT06968039
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
- 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.-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Working Memory Training-Related Scores An hour before and after interventions Working Memory Related Task is a widely used paradigm in cognitive psychology and neuroscience to study memory retention and recognition. In this task, participants are first presented with a image stimulus for a brief period. After a delay interval, they are shown a set of test stimuli, including the original sample and one or more distractors. The participants' task is to identify whether the sample stimulus is present among the test items. This paradigm allows researchers to investigate the effects of delay duration on memory accuracy and the neural mechanisms underlying memory encoding, maintenance, and retrieval.
SDMT (Symbol Digit Modalities Test) An hour before and after interventions. The SDMT is a widely used test to measure processing speed and cognitive flexibility. Participants are asked to match symbols with corresponding numbers according to a key, which they must do as quickly as possible. This task assesses visual scanning, motor speed, and the ability to shift attention.
- Secondary Outcome Measures
Name Time Method AVLT (Auditory Verbal Learning Test) Before interventions The AVLT is a neuropsychological test used to assess verbal memory. It involves presenting a list of words to participants, who are then required to recall the words immediately after presentation and after a delay. The test examines both short-term and long-term verbal memory retention, as well as the ability to organize and retrieve information.
Digit Span Test An hour before interventions The Digit Span test measures working memory and attention. Participants are presented with a sequence of digits, and they must repeat the sequence either in the same order (forward span) or in reverse order (backward span). The test assesses both short-term memory and cognitive flexibility.
BVMTR (Brief Visual Memory Test-Revised) An hour before and after interventions. The BVMTR is designed to evaluate visual memory and recognition. Participants are shown a set of geometric shapes, which they must remember. After a delay, they are asked to identify which shapes were previously shown among distractors. This test helps in assessing visual memory and the ability to recognize visual stimuli.
STROOP (Stroop Color and Word Test) An hour before and after interventions. The Stroop test assesses cognitive flexibility and the ability to inhibit automatic responses. Participants are presented with words printed in different ink colors and must name the ink color rather than reading the word itself (which can be incongruent). The task evaluates cognitive control, selective attention, and response inhibition.
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China