Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Genetic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Genetic epilepsy

Patients with epilepsies of genetic etiology

Group Type EXPERIMENTAL

transcranial magnetic stimulation (TMS)

Intervention Type 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).

Patients with primary headache

Patients with primary headache with non-migraine features

Group Type EXPERIMENTAL

transcranial magnetic stimulation (TMS)

Intervention Type 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).

Interventions

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transcranial magnetic stimulation (TMS)

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No