Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients

NCT06968039 | Recruiting

• 1 other identifier: xw-tES-04
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Electric Stimulation

Outcome Measures

Primary Outcomes (2)

• Working Memory Training-Related Scores

  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.

  An hour before and after interventions

• SDMT (Symbol Digit Modalities Test)

  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.

  An hour before and after interventions.

Secondary Outcomes (4)

• AVLT (Auditory Verbal Learning Test)

  Before interventions

• Digit Span Test

  An hour before interventions

• BVMTR (Brief Visual Memory Test-Revised)

  An hour before and after interventions.

• STROOP (Stroop Color and Word Test)

  An hour before and after interventions.

Other Outcomes (5)

• EDSS (Expanded Disability Status Scale)

  At baseline.

• MFIS (Modified Fatigue Impact Scale)

  At baseline

• MSIS (Multiple Sclerosis Impact Scale)

  At baseline

Study Arms (2)

Neuromodulation Group

EXPERIMENTAL

Device: Neuroelectrics StarStim 32

Sham Neuromodulation Group

SHAM COMPARATOR

Device: Neuroelectrics StarStim 32

Interventions

Neuroelectrics StarStim 32 DEVICE

Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal and parietal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session for one time with EEG monitoring conducted before and after electrical stimulation.

Neuromodulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10000, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jun wei Hao, MD

CONTACT

010+83198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)