Clinical trial NCT06241963: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy
Official title: The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The changes of Epilepsy diary
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
Secondary outcomes:
measure: The changes of VEEG
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of resting-state functional connectivity
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of resting motor threshold(RMT）
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of glutamate receptor-mediated intracortical facilitation (ICF)
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of GABA-A receptor-mediated short septal cortical inhibition (SICI)
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of GABA-B receptor-mediated long septal cortical inhibition (LICI).
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of MoCA Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of Hamilton Depression Rating Scale (HAMD) Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of Hamilton Anxiety Scale (HAMA) Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of Chinese auditory learning test Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of TMT (Trail Making Test) Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
measure: The changes of Face associative memory Score
timeFrame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: