Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy

NCT ID: NCT06558890

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-08
• Study Completion Date: 2024-12-31

Brief Summary

Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG.

Detailed Description

This study is a single-center, observational study.This study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsy.For the recruited patients with refractory TLE (Temporal Lobe Epilepsy), they will undergo a 6-week treatment with tACS (transcranial alternating current stimulation) protocol (2mA, 10Hz, 20 minutes per side), following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days, and then a reinforcement treatment once a week, completing a total of 14 treatments.Before treatment, at week 10, and at week 14, the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients. EEG data and near-infrared spectroscopy (NIRS) brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment. Magnetic resonance imaging (MRI) data will be acquired before treatment, after two consecutive weeks of treatment, and after six weeks of intensified treatment. Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment, in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy (TLE).

Conditions

Transcranial Electrical Stimulation; Temporal Lobe Epilepsy; Magnetic Resonance Imaging; Electroencephalogram

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial Alternating Current Stimulation Intervention

Patients with refractory TLE recruited for the study will undergo a 6-week treatment with the tACS (transcranial alternating current stimulation) protocol, which involves a 2mA current at 10Hz for 20 minutes on both sides. The treatment schedule is 5 days of treatment followed by 2 days of rest, and then another 5 days of treatment, with a weekly reinforcement treatment, for a total of 14 sessions.

Group Type: EXPERIMENTAL

Transcranial Alternating Current Stimulation

Intervention Type: DEVICE

Transcranial Alternating Current Stimulation

Interventions

Transcranial Alternating Current Stimulation

Transcranial Alternating Current Stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 65 years old;

2. Diagnosed with refractory temporal lobe epilepsy as defined by the International League Against Epilepsy (ILAE) (failure to achieve seizure-free status after adequate trials of two appropriate antiepileptic drugs);

3. Duration of epilepsy is at least 2 years, with a seizure frequency of at least 2 times per 4 weeks in the three months before enrollment;

4. Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;

5. Capable of cooperating to complete the treatment and related examination items;

6. The patient and family members fully understand and voluntarily sign the informed consent form.

Exclusion Criteria

1. Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);

2. Psychogenic epilepsy or pseudo-epilepsy;

3. Concurrent severe infections, cerebrovascular diseases, malignant tumors, or other diseases with severe dysfunction of major organs such as the heart, liver, and kidneys, or with mental disorders;

4. Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);

5. History of head trauma or other brain-related diseases;

6. Pregnant or breastfeeding women;

7. Participation in other clinical trials at the same time;

8. Changes in medication treatment plan during baseline, treatment, or follow-up period;

9. Withdrawal of informed consent by the patient or family members.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang Wen

Role: STUDY_CHAIR

The First Affiliated Hospital of Air Force Medicial University

Locations

Xijing Hospital of Air Force Military Medical University

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guan Xiao, Master

Role: CONTACT

guanxiao0223@163.com

18392320919

Facility Contacts

Guan Xiao, master

Role: primary

guanxiao0223@163.com

18392320919

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Other Identifiers

KY20232387

Identifier Type: -

Identifier Source: org_study_id