NCT06241963

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy

The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.

Detailed description

All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition transcranial direct current stimulation (HD-tDCS) treatment.Upon meeting the inclusion criteria and providing informed consent, each participant will complete clinical assessments by a trained investigator and HD-tDCS treatment at Anhui mental health centre. At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 . In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold. The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.

Conditions

• Transcranial Direct Current Stimulation
• EEG
• Functional Magnetic Resonance Imaging
• Refractory Epilepsy
• Transcranial Magnetic Stimulation

Interventions

Type	Name	Description
DEVICE	Active Comparator: Unilateral real High definition transcranial direct current stimulation	Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed
DEVICE	Active Comparator: Bilateral real High definition transcranial direct current stimulation	Improved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed
DEVICE	Sham Comparator: Sham High definition transcranial direct current stimulation	The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors

Timeline

• Start date: 2024-02-12
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-02-05
• Last updated: 2024-02-20

Locations

1 site across 1 country: China