cTBS Targeting Cerebellum for Drug-refractory Epilepsy

January 3, 2023 updated by: Xijing Hospital

Bilateral Continuous Theta Burst Stimulation of Cerebellum for Drug-refractory Epilepsy: A Double Blind, Randomised, Single Centre, Crossover Clinical Trial

This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week washout periods, following which the patient will cross over to have the opposite condition for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a) Participants who are in line with the diagnostic criteria for epilepsy,
  • b) Participants who are diagnosed as drug-refractory epilepsy,
  • c) Participants who has duration of epilepsy ≥2 years and seizure frequency ≥2 times per month,
  • d) The type and dosage of anti-epileptic drugs do not change during the experiment,
  • e) Participants or their families reject invasive therapy, such as operation,
  • f) Participants and their families are aware of this study and sign informed consent.

Exclusion Criteria:

  • a) Participants who are in status epilepticus,
  • b) Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
  • c) Participants who are diagnosed as syncope, hysteria or other non-epileptic attacks,
  • d) Participants who are in pregnancy or lactating,
  • e) Participants who have incomplete clinical data,
  • f) Patients have contraindications of repeated transcranial magnetic stimulation.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cTBS First
The first stage, participants received cTBS treatment for a total of 10 times during two weeks, then followed up for eight weeks; the second stage, participants are treated with pseudo-stimulation for a total of 10 times during two weeks, then followed up for 8 weeks similarly.
Device: cTBS First
Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 33.2s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group.
Experimental: Pseudo-stimulation First
The first stage, participants received pseudo-stimulation treatment for a total of 10 times during two weeks, then followed up for eight weeks; the second stage, participants are treated with cTBS for a total of 10 times during two weeks, then followed up for 8 weeks similarly.
Device: Pseudo-stimulation First
The transcranial magnetic stimulator operating system has a built-in control group option, in which the stimulation parameters are set consistent with the research group, which can realize the operation of only sound without stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seizure reduction rate in pre- and post-treatment
Time Frame: 8 weeks
A 28-day baseline for seizure frequency will be recorded by the patients themselves or their relatives before therapy and then compare to the frequency at 4-week and 8-week after treatment, finally, the rate of reduction in seizure frequency was obtained
8 weeks
responder rate
Time Frame: 8 weeks
proportion of people with a 50% or greater reduction in seizure frequency following the treatment period
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOLIE-31 scale scores
Time Frame: 8 weeks
Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life.
8 weeks
scalp electroencephalogram
Time Frame: 8 weeks
Routine scalp electroencephalogram at 40 min
8 weeks
IQ
Time Frame: 8 weeks
Wechsler Abbreviated Scale of Intelligence. Above 130 points very excellent, 120-129 excellent, 110-119 above average, 90-109 average, 80-89 below average, 70-79 critical level, below 69 mental retardation, 50-69 mild mental retardation, 35-49 moderate mental retardation, 20-34 severe mental retardation, less than 20 extremely severe mental retardation.
8 weeks
MQ
Time Frame: 8 weeks
Wechsler Memory Scale. Above 130 points very excellent, 120-129 excellent, 110-119 above average, 90-109 average, 80-89 below average, 70-79 critical level, below 69 mental retardation, 50-69 mild mental retardation, 35-49 moderate mental retardation, 20-34 severe mental retardation, less than 20 extremely severe mental retardation.
8 weeks
MoCA
Time Frame: 8 weeks
Montreal Cognitive Assessment. A max score is 30 points, and a score ≥ 26 is considered normal.
8 weeks
MMSE
Time Frame: 8 weeks
Mini-Mental State Examination. The normal values are defined as: illiterates >17, primary school >20, junior high school or above >24.
8 weeks
HAMD
Time Frame: 8 weeks
Hamilton Depression Scale. Total score <7 means normal; between 7 and 17 means possible depression; between 17 and 24 , definitely have depression; >24 means severe depression.
8 weeks
HAMA
Time Frame: 8 weeks
Hamilton Anxiety Scale. The total score ≥29 may be severe anxiety; ≥21, obvious anxiety; ≥14, definite anxiety; ≥7, may have anxiety; If the score <7, there are no symptoms of anxiety.
8 weeks
SCL-90
Time Frame: 8 weeks
Self-reporting Inventory. The total symptom index scores ranged from 1 to 1.5, indicating that the subjects did not feel the symptoms listed in the scale. Between 1.5 and 2.5, indicates that the subject feels a little symptomatic, but not occur frequently. Between 2.5 and 3.5, indicates that the subject feels symptoms, and is mild to moderate. The score between 3.5 and 4.5 indicates that the subjects feel symptoms, and the degree was moderate to severe. A score between 4.5 and 5 indicates that the subject feels symptoms, and the frequency and intensity are very severe.
8 weeks

Collaborators and Investigators

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

Sponsor

Xijing Hospital

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)

August 2, 2021

Primary Completion (Actual)

August 24, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XijingSN

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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