Clinical trial NCT05042726: cTBS Targeting Cerebellum for Drug-refractory Epilepsy
Official title: Bilateral Continuous Theta Burst Stimulation of Cerebellum for Drug-refractory Epilepsy: A Double Blind, Randomised, Single Centre, Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Refractory Epilepsy
Keywords: Drug Refractory Epilepsy
Continuous θ Burst Stimulation
Cerebellar Dentate Nucleus
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: seizure reduction rate in pre- and post-treatment
timeFrame: 8 weeks
measure: responder rate
timeFrame: 8 weeks
Secondary outcomes:
measure: QOLIE-31 scale scores
timeFrame: 8 weeks
measure: scalp electroencephalogram
timeFrame: 8 weeks
measure: IQ
timeFrame: 8 weeks
measure: MQ
timeFrame: 8 weeks
measure: MoCA
timeFrame: 8 weeks
measure: MMSE
timeFrame: 8 weeks
measure: HAMD
timeFrame: 8 weeks
measure: HAMA
timeFrame: 8 weeks
measure: SCL-90
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
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