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

August 16, 2024 updated by: Xijing Hospital

A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy: A Single-center, Observational Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China
        • Recruiting
        • Xijing Hospital of Air Force Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Transcranial Alternating Current Stimulation
Transcranial Alternating Current Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared to baseline, the reduction rate of epileptic seizure frequency
Time Frame: baseline, 10 weeks,14 weeks after treatment
((post-treatment - baseline) / baseline).
baseline, 10 weeks,14 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire
Time Frame: baseline, 10 weeks,14 weeks after treatment
The scoring method for the QOLIE-31 Questionnaire involves several key steps, as follows:1.Initial Score Calculation： the raw scores for each item on the scale can be converted to a range of 0 to 100；2.Weighted Scoring：the transformed scores are multiplied by their respective weights；3.Total Score Calculation:all the weighted scores are added together to obtain the total score. Total Score=(Emotional Symptoms Score×25+Psychological Function Score×25+Social Function Score×20+Life Domains Score×17+Additional Items Score×13)/5 In the QOLIE-31 scoring system, a higher score indicates a better quality of life for individuals with epilepsy.
baseline, 10 weeks,14 weeks after treatment
MRI measures
Time Frame: baseline，2weeks，14weeks after treatment
This study primarily applied resting-state blood oxygen level dependent functional magnetic resonance imaging (BOLD) and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellum in healthy subjects and patients before and after two weeks of transcranial electrical stimulation (TES) treatment, as well as the changes in the cerebellar cortical white matter fiber bundles two months after treatment. ALFF and ReHo analyses can reveal the characteristics of local neural activity in the brain during the resting state, and abnormal brain regions can serve as regions of interest (ROIs) for subsequent functional connectivity analysis. Additionally, the flow of cerebrospinal fluid (CSF) can be measured to reflect the functional state of the glymphatic system, which can be used to assess the therapeutic effects and the impact on lymphatic drainage function.
baseline，2weeks，14weeks after treatment
electroencephalogram(EEG)
Time Frame: baseline，2weeks after treatment
The changes in EEG will constitute secondary research outcomes. EEG can evaluate the changes in brain functional connectivity in patients before and after transcranial electrical stimulation (TES) treatment. In addition, the alterations in the power spectrum of each frequency band, including delta, alpha, beta, theta, low gamma, and high gamma, will also be measured before and after TES treatment.
baseline，2weeks after treatment
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging
Time Frame: baseline，2weeks after treatment
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging can assess the changes in brain function of patients before and after transcranial electrical stimulation (TES) treatment.Changes in brain functional connectivity as measured by near-infrared spectroscopy (fNIRS) imaging before and after transcranial electrical stimulation treatment.
baseline，2weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Jiang Wen, Xijing Hospital of Air Force Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2024

Primary Completion (Actual)

August 11, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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