Assessment of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation (cTBS) Effects in Generalized Epilepsy Patients.

NCT06797791 | Completed DMC

• 1 other identifier: 19062018-85
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical study is to assess the efficacy of multifocal theta burst transcranial magnetic stimulation in the prevention of epileptic seizures in adult patients with generalized epilepsy. The main questions it aims to answer are:

• How does multifocal continuous theta burst stimulation (cTBS) impact the frequency and severity of epileptic seizures?
• Does cTBS influence the quality of life in patients with generalized epilepsy?
• What is the safety and tolerability profile of the experimental multifocal cTBS protocol?

Conditions

Generalized Epilepsy

Keywords

TBS; cTBS; IGE; Generalized; Epilepsy; Theta; Burst; Transcranial; Magnetic; Stimulation; Continuous

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  ≥50% improvement from Baseline in seizure frequency

  at 12 weeks

Secondary Outcomes (3)

• Quality of Life in Epilepsy (QOLIE-31) Inventory

  at 12 weeks

• Seizure Severity Questionnaire (SSQ)

  at 12 weeks

• Patient Global Impression of Change (PGIC)

  at 12 weeks

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment

Study Arms (1)

Multifocal continuous theta burst transcranial magnetic stimulation

EXPERIMENTAL

After determining the resting motor threshold (RMT), all subjects underwent 6 sessions of continuous theta burst stimulation (cTBS) for 6 consecutive days according to the research protocol. TBS sessions were accompanied by parallel high-density electroencephalography (hdEEG) monitoring. Afterward, a follow-up period of up to three months with visits at predefined intervals of 4, 8, and 12 weeks was carried out.

Device: Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation

Interventions

Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation DEVICE

The experimental stimulation protocol included 3 trains of cTBS with an inter-train interval of 10 min. Each train of cTBS consisted of 600 pulses applied in blocks at the theta frequency (200ms) with a duration of 40 s. A block of pulses consisted of 3 pulses at 50Hz frequency, stimulus intensity being estimated as 80% of the RMT. Stimulation application was performed by positioning the Magventure MMC-140 coil over the vertex (Cz) according to the 10-20 EEG system overlapping bilateral motor and somatosensory cortical areas.

Also known as: cTBS

Multifocal continuous theta burst transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).

You may not qualify if:

• refusal to sign the informed consent;
• focal, combined or unknown epilepsy (according to ILAE criteria);
• drug-resistant form of epilepsy (according to ILAE definition);
• history or symptoms of renal or hepatic failure;
• history of oncological disorder;
• uncontrolled high blood pressure;
• cognitive impairment;
• psychiatric disorders;
• signs of structural brain injury or focal neurological symptoms;
• use of opioids or muscle relaxants;
• history of substance abuse;
• ferromagnetic implants in head and neck regions;
• cardiac pacemakers;
• pregnancy or lactation.

Sponsors & Collaborators

• Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (2)

Emergency Medicine Institute

Chisinau, MD2004, Moldova

Location

Nicolae Testemițanu State University of Medicine and Pharmacy

Chisinau, MD2004, Moldova

Location

MeSH Terms

Conditions

Epilepsy, Generalized; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Asst. prof., PhD candidate

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: January 28, 2025
• Study Start: December 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

MO (2)