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Clinical Trials/NCT06284291
NCT06284291
Recruiting
Not Applicable

Use of Transcranial Magnetic Stimulation (TMS) as a Surrogate of Pathophysiology in Genetic Epilepsies

Meyer Children's Hospital IRCCS1 site in 1 country150 target enrollmentNovember 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Meyer Children's Hospital IRCCS
Enrollment
150
Locations
1
Primary Endpoint
TEP amplitude
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2023
End Date
March 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Meyer Children's Hospital IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Simona Balestrini

Principal Investigator

Meyer Children's Hospital IRCCS

Eligibility Criteria

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

Outcomes

Primary Outcomes

TEP amplitude

Time Frame: 24 months

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

ICF

Time Frame: 24 months

Intracortical facilitation (ratio)

TEP latency

Time Frame: 24 months

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

Resting motor threshold

Time Frame: 24 months

Resting motor threshold (%MSO)

SICI

Time Frame: 24 months

Short Interval intracortical inhibition (ratio)

LICI

Time Frame: 24 months

Long Interval Intracortical inhibition (ratio)

Study Sites (1)

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