Slow Oscillatory Transcranial Direct Current Stimulation for Refractory Focal Epilepsy

NCT07684352 | Completed

• 2 other identifiers: so-tDCS-RE-20242022YFC3600500
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluated whether a type of non-invasive brain stimulation called slow-oscillatory transcranial direct current stimulation (so-tDCS) can reduce seizure frequency in patients with drug-resistant focal epilepsy. Ten patients received 14 days of so-tDCS (2 mA, 1 Hz) for 20 minutes twice daily, guided by their individual seizure focus identified by EEG and MRI. Seizure frequency and epileptiform discharges were measured before, during, and up to 8 weeks after treatment. The study also assessed safety and tolerability. Results showed that so-tDCS significantly reduced seizure frequency, with the greatest effect occurring during the first week of treatment, and the benefit was sustained during follow-up. No serious adverse events were reported. These preliminary findings suggest that so-tDCS may be a safe and effective non-invasive option for refractory focal epilepsy, but larger sham-controlled trials are needed to confirm efficacy.

Conditions

Refractory Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in seizure frequency

  Percentage change in weekly seizure frequency from baseline to the end of the 2-week treatment period, and to the end of the 8-week follow-up period.

  Baseline (4 weeks), during treatment (weeks 1-2), and follow-up (weeks 3-10)

Study Arms (1)

so-tDCS

EXPERIMENTAL

Participants received 14 days of slow-oscillatory transcranial direct current stimulation (so-tDCS) over the neuroimaging-defined epileptogenic zone (cathode), with reference anode at FP1/FP2. Stimulation: 1 Hz, 2 mA, two 20-minute sessions per day (20-minute interval), for 14 consecutive days.

Device: Slow-oscillatory transcranial direct current stimulation (so-tDCS)

Interventions

Slow-oscillatory transcranial direct current stimulation (so-tDCS) DEVICE

1 Hz sinusoidal oscillatory current, 2 mA peak-to-peak, delivered via sponge electrodes (13.68 cm²) soaked in 0.9% saline. Cathode placed over individual epileptogenic zone (defined by MRI, FDG-PET, MEG, and scalp EEG). Reference anode placed at FP1 or FP2 (contralateral). Each session: 20 minutes with 20-second ramp-up/ramp-down. Two sessions per day, separated by a 20-minute rest period, for 14 consecutive days.

so-tDCS

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Neurology

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: January 13, 2024
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)