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

NCT06241963 | Recruiting

• 1 other identifier: AHMU-tDCS-epilepsy
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Refractory Epilepsy; Functional Magnetic Resonance Imaging; EEG; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• The changes of Epilepsy diary

  The reduction of seizure frequency in patients with epilepsy will constitute the primary outcome measure to evaluate the efficacy of HD-tDCS, reflecting the improvement of patients' clinical symptoms. Patients and family members are asked to keep an epilepsy diary to record the time, duration, and status of the seizure.

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

Secondary Outcomes (12)

• The changes of VEEG

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

• The changes of resting-state functional connectivity

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

• The changes of resting motor threshold(RMT）

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

• The changes of glutamate receptor-mediated intracortical facilitation (ICF)

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

• The changes of GABA-A receptor-mediated short septal cortical inhibition (SICI)

  Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

Study Arms (3)

Unilateral real High definition transcranial direct current stimulation

ACTIVE COMPARATOR

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 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.

Device: Active Comparator: Unilateral real High definition transcranial direct current stimulation

Bilateral real High definition transcranial direct current stimulation

ACTIVE COMPARATOR

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.

Device: Active Comparator: Bilateral real High definition transcranial direct current stimulation

Sham High definition transcranial direct current stimulation

SHAM COMPARATOR

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. The 30 subjects were randomly divided into two groups, 15 receiving bilateral Sham HD-tDCS and 15 receiving unilateral Sham HD-tDCS. 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.

Device: Sham Comparator: Sham High definition transcranial direct current stimulation

Interventions

Active Comparator: Unilateral real High definition transcranial direct current stimulation DEVICE

Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed

Unilateral real High definition transcranial direct current stimulation

Active Comparator: Bilateral real High definition transcranial direct current stimulation DEVICE

Improved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed

Bilateral real High definition transcranial direct current stimulation

Sham Comparator: Sham High definition transcranial direct current stimulation DEVICE

The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors

Sham High definition transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of refractory epilepsy
• Right-handed and aged 18-50 years old and primary school education or above;
• No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
• During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.

You may not qualify if:

• organic brain injury, neurological diseases or serious physical diseases;
• Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
• There are contraindications for MRI or EEG or transcranial magnetic stimulation.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62923704; wangkai1964@126.com

Xingui Chen, PhD

CONTACT

+8615955161468; chen_xin_gui@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 5, 2024
• Study Start: February 12, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)