Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284291
• Other study ID #: TMSpath
• Secondary ID: RF-2021-12372804
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Simona Balestrini, MD
• Phone: 0555662719
• Email: simona.balestrini[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Genetic Disease
• Genetic Diseases, Inborn

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital IRCCS	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting motor threshold	Resting motor threshold (%MSO)	24 months
Primary	SICI	Short Interval intracortical inhibition (ratio)	24 months
Primary	ICF	Intracortical facilitation (ratio)	24 months
Primary	LICI	Long Interval Intracortical inhibition (ratio)	24 months
Primary	TEP amplitude	Amplitude of each component of the TMS-evoked potential (mV)	24 months
Primary	TEP latency	Latency of each component of the TMS-evoked potential (msec)	24 months