Generalized EpilepsyTBS-GEMNCT06797791
Assessment of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation (cTBS) Effects in Generalized Epilepsy Patients.
A study testing Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation in people with Generalized Epilepsy, run by Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu at 2 sites in Moldova.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Epilepsy
- What is being tested?
- Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesMoldova
- Study dates
- 1 Dec 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Moldova2 sites
Emergency Medicine Institute
Chisinau, MD2004
Nicolae Testemițanu State University of Medicine and Pharmacy
Chisinau, MD2004
About this study
Official title: 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?
- Conditions
- Generalized Epilepsy
- Being tested
- Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation
- Keywords
- TBS, cTBS, IGE, Generalized, Epilepsy, Theta, Burst, Transcranial, Magnetic, Stimulation, Continuous
- Medical subject headings
- Epilepsy, Generalized, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal Continuous Theta Burst Transcranial Magnetic StimulationDevice
Also called cTBS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
≥50% improvement from Baseline in seizure frequency
Measured: at 12 weeks
Secondary outcomes (3)
Quality of Life in Epilepsy (QOLIE-31) Inventory
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.
Measured: at 12 weeks
Seizure Severity Questionnaire (SSQ)
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.
Measured: at 12 weeks
Patient Global Impression of Change (PGIC)
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".
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Dec 2021
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Pavel Leahu, Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797791
- Sponsor's protocol ID
- 19062018-85
- Acronym
- TBS-GEM
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Theta Burst Transcranial Magnetic Stimulation in Generalized Epilepsy Management.
- ClinicalTrials.gov ID
- NCT06797791
- Acronym / sponsor ID
- TBS-GEM / 19062018-85
- Conditions
- Generalized Epilepsy
- Keywords
- TBS, cTBS, IGE, Generalized, Epilepsy, Theta, Burst, Transcranial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitatea de Stat de Medicina si Farmacie Nicolae TestemiţanuUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifocal continuous theta burst transcranial magnetic stimulation | Experimental | Device: Multifocal Continuous Theta Burst Transcranial Magnetic StimulationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifocal Continuous Theta Burst Transcranial Magnetic StimulationAlso: cTBSThe 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. | Device | Multifocal continuous theta burst transcranial magnetic stimulation |
Primary outcome
Seizure frequency
Time frame: at 12 weeks
≥50% improvement from Baseline in seizure frequency
3 secondary outcomes
Quality of Life in Epilepsy (QOLIE-31) Inventory
Time frame: at 12 weeks
Seizure Severity Questionnaire (SSQ)
Time frame: at 12 weeks
Patient Global Impression of Change (PGIC)
Time frame: at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation in people with Generalized Epilepsy, run by Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu at 2 sites in Moldova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.