NCT07029386

Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases

The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed. Anticipated Results: the investigators 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

• Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Interventions

Type	Name	Description
DEVICE	tES	his study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group. Neuromodulation Group: Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training Stimulation parameters: Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and functional MRI (fMRI) monitoring before and after electrical stimulation
DEVICE	tES	Use the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study

Timeline

• Start date: 2024-12-15
• Primary completion: 2027-07-01
• Completion: 2027-10-01
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: China