NCT06284291

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 15, 2024

Last Update Submit

February 27, 2024

Conditions

EpilepsyGenetic Disease

Outcome Measures

Primary Outcomes (6)

  • Resting motor threshold

    Resting motor threshold (%MSO)

    24 months

  • SICI

    Short Interval intracortical inhibition (ratio)

    24 months

  • ICF

    Intracortical facilitation (ratio)

    24 months

  • LICI

    Long Interval Intracortical inhibition (ratio)

    24 months

  • TEP amplitude

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

    24 months

  • TEP latency

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

    24 months

Study Arms (2)

Genetic epilepsy

EXPERIMENTAL

Patients with epilepsies of genetic etiology

Diagnostic Test: transcranial magnetic stimulation (TMS)

Patients with primary headache

EXPERIMENTAL

Patients with primary headache with non-migraine features

Diagnostic Test: transcranial magnetic stimulation (TMS)

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).

Genetic epilepsyPatients with primary headache

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<3 years
  • Pregnancy status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

MeSH Terms

Conditions

EpilepsyGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Simona Balestrini, MD

CONTACT

0555662719simona.balestrini@meyer.it

Renzo Guerrini, MD

CONTACT

0555662573renzo.guerrini@meyer.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 28, 2024

Study Start

November 22, 2023

Primary Completion

November 30, 2025

Study Completion

March 1, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)