Actively Recruiting
The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy
Led by Anhui Medical University · Updated on 2024-02-20
90
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects and safety of high definition transcranial direct current stimulation (HD-tDCS) in patients with refractory epilepsy. This study aims to understand how HD-tDCS affects brain function and its therapeutic mechanism by comparing different stimulation approaches in this condition. Participants are adults aged 18 to 50 years with refractory epilepsy who meet specific health and cognitive criteria. The study includes three groups receiving different HD-tDCS treatments: bilateral active stimulation on both sides of the brain twice daily for 20 sessions over 10 workdays, unilateral active stimulation on one side once daily for 10 sessions over 10 workdays, and a sham stimulation group acting as a control. Electrodes are placed on specific areas of the scalp for targeted brain stimulation. The sham treatment mimics the procedure but only delivers brief stimulation during ramp-up and ramp-down periods. Participants undergo clinical assessments, neuropsychological tests, magnetic resonance imaging (MRI), video electroencephalogram (VEEG), and resting motor threshold measurements before and after treatment. Follow-ups occur at 4 weeks and 12 weeks after the final session to track symptoms and brain activity changes. The primary outcome is the change in epilepsy diary recordings, while secondary outcomes include various brain activity and cognitive function measures. Safety and treatment adherence are carefully monitored throughout the study.
CONDITIONS
Brief Title
High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of refractory epilepsy
- Right-handed and aged 18-50 years old
- Primary school education or above
- No major neurological or mental illness
- No head injury, alcohol dependence, or drug dependence
- No smoking, drinking, illness, psychotropic drugs use, or major mood changes during the experiment
You will not qualify if you...
- Organic brain injury, neurological diseases, or serious physical diseases
- History of substance abuse or drug dependence
- Use of antipsychotic drugs in the past three months
- Serious suicidal tendencies
- Contraindications for MRI, EEG, or transcranial magnetic stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 consecutive workdays
Participants receive High Definition Transcranial Direct Current Stimulation (HD-tDCS) treatment according to their assigned group: unilateral, bilateral, or sham stimulation.
10 to 20 sessions over 10 days depending on treatment group
Duration - 12 weeks
Participants are followed for clinical symptom assessments after the last treatment session.
Visits at 4 weeks and 12 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
K
Kai Wang, PhD
X
Xingui Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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