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

January 27, 2025 updated by: Pavel Leahu, Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Multifocal Theta Burst Transcranial Magnetic Stimulation in Generalized Epilepsy Management.

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD2004
        • Emergency Medicine Institute
      • Chisinau, Moldova, Republic of, MD2004
        • Nicolae Testemițanu State University of Medicine and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifocal continuous theta burst transcranial magnetic stimulation
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
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.
Other Names:
  • cTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure frequency
Time Frame: at 12 weeks
≥50% improvement from Baseline in seizure frequency
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in Epilepsy (QOLIE-31) Inventory
Time Frame: at 12 weeks
Exploratory analyses will investigate the changes in the 31-item Quality of Life in Epilepsy (QOLIE-31) score from Baseline due to study protocol and interventions. The questionnaire comprises seven categories: worry about epileptic seizures, emotional well-being, energy/fatigue, social function, cognitive function, medication effects, and general quality of life. The scale is scored from 0 to 100. Higher scores reflect a higher quality of life.
at 12 weeks
Seizure Severity Questionnaire (SSQ)
Time Frame: at 12 weeks
Exploratory analyses will investigate the changes in the Seizure Severity Questionnaire (SSQ) score from Baseline due to study protocol and intervention. The SSQ is a 24-item questionnaire that includes questions regarding the frequency and usefulness of warning signs, severity and disturbance of ictal movements, loss of consciousness, and frequency, severity, and postictal cognitive, emotional, and physical disturbance. Scores per category range from 1 to 7, with higher scores indicating greater severity.
at 12 weeks
Patient Global Impression of Change (PGIC)
Time Frame: at 12 weeks
Improvement in Patient Global Impression of Change (PGIC) score from Baseline. PGIC is used to assess patients' perceptions of changes after treatment. It is a 7-point scale with the options "very much improved", "much improved", "minimally improved", "no change", "minimally worsened", "much worsened" and "very much worsened".
at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment
After each continuous Theta Burst Stimulation (cTBS) session an assessment of possible adverse events ( CTCAE v4.0 terms) occurring during and/or immediately after stimulation was done.
From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Collaborators

Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19062018-85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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