Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies

Meyer Children's Hospital IRCCS150 enrolled

Overview

Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Epilepsy Genetic Disease

Interventions

transcranial magnetic stimulation (TMS)DIAGNOSTIC_TEST

The STM9000 Standard-BI stimulator with 70 mm refrigerated butterfly stimulator (EB Neuro, Florence, Italy) controlled by Galileo Netbrain 9000 hardware and software (EB Neuro, Florence, Italy) is used. EMG data are recorded from the contralateral dorsal first interosseous muscle using gelled surface electrodes. EEG data are recorded by using the BE PLUS PRO Advanced EEG/EMG/EP amplifier (EB Neuro, Florence, Italy IT).

Eligibility

Sex: ALLMin age: 3 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged \>3 years and adults * Diagnosis of epilepsy with presumed or confirmed genetic etiology. Diagnosis of genetic epilepsy is made by next-generation sequencing (NGS) analysis * or Diagnosis of primary (non-hemicranial) headache, in the absence of alterations on neuroimaging, and no known genetic condition * Obtaining informed consent Exclusion Criteria: * Age \<3 years * Presence of contraindications to TMS: history of head or eye trauma with inclusion of metal fragments, cardiac pacemaker, arrhythmic heart disease, hearing implants, implantation of drug delivery devices, piercings or tattoos with metallic ink. * Pregnancy status

Locations (1)

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Outcomes

Primary Outcomes

Resting motor threshold

Resting motor threshold (%MSO)

Time frame: 24 months

SICI

Short Interval intracortical inhibition (ratio)

Time frame: 24 months

ICF

Intracortical facilitation (ratio)

Time frame: 24 months

LICI

Long Interval Intracortical inhibition (ratio)

Time frame: 24 months

TEP amplitude

Amplitude of each component of the TMS-evoked potential (mV)

Time frame: 24 months

TEP latency

Latency of each component of the TMS-evoked potential (msec)

Time frame: 24 months

Central Contacts

Simona Balestrini, MD

CONTACT

0555662719 simona.balestrini@meyer.it

Renzo Guerrini, MD

CONTACT

0555662573 renzo.guerrini@meyer.it

Data from ClinicalTrials.gov

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