cTBS Targeting Cerebellum for Drug-refractory Epilepsy

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Drug Refractory Epilepsy

Treatments: Device: Pseudo-stimulation First; Device: cTBS First

Study type: Interventional

Funder types: Other

Identifiers

NCT05042726

XijingSN

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

cTBS First

Experimental group

Description:

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.

Treatment:

Device: cTBS First

Pseudo-stimulation First

Experimental group

Description:

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.

Treatment:

Device: Pseudo-stimulation First