EpilepsyNCT03154307
Repeated TMS at Low Frequencies to Reduce Seizure Occurrence
A study testing Low frequency repeated TMS (LF-rTMS) in people with Epilepsy and Status Epilepticus, run by Baptist Health South Florida at 1 site in United States.
Trial summary
Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with the intent to reduce the occurrence of seizures over time (long-term protocol). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy, Status Epilepticus, Epilepsia Partialis Continua
- What is being tested?
- Low frequency repeated TMS (LF-rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2016to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience ≥ 3 seizures/month in the month prior to starting study (any type of seizure will count)
- No status epilepticus in the last 12 months
- No change in medication in last 30 days
- Epilepsia partialis continua or status epilepticus
- At least 2 medications failed
- At least 24 hours of acute phase
Who cannot join
- Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
- Presence of intracranial metal (e.g., aneurysm clip)
- Unable to cooperate with non-sedated, navigated TMS testing
- Short-term protocol:
- Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
- Presence of intracranial metal (e.g., aneurysm clip)
Trial locations and contacts
1 site in 1 country.
About this study
Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with the intent to reduce the occurrence of seizures over time (long-term protocol). Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module. Up to 100 individuals 18 to 80 years with epilepsy will be enrolled.
In addition, a short-term protocol has been added to test whether LF-rTMS can reduce or suppress status epilepticus in medically refractory participants.
Read the detailed description
Long term protocol: Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with to reduce the occurrence of seizures over time. Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). Using a double-blinded, sham-controlled design, we will enroll up to 100 participants aged 18-80 with focal and generalized retractable epilepsy. Baseline data will include a detailed seizure diary over 4 weeks, psychometric testing/neuropsychology evaluation, and 20-minute EEG recordings. Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120%MT, and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. The protocol will be divided in 3 groups (Groups 1, 2 and 3) as follows:
- Groups 1, 2, and 3: LF-rTMS for 2 weeks (5 days per week for total of 10 days).
- Group 1: protocol total duration: 1 year: LF-rTMS 1 session/week for 1 month (4 days), and LF-rTMS 1 session/month for 11 months
- Group 2: protocol total duration: 1 year: LF-rTMS 1 session/month for 12 months
- Group 3 (placebo protocol, total duration: 1 year): LF-rTMS 1 session/week for 1 month (4 days); and LF-rTMS 1session/month.
During each session EEG may be recorded. Also, we will obtain the number, frequency, and duration of seizure events from an ongoing seizure diary. Psychometric testing will be performed at the beginning of study, 3 months, and at the end of the study. Thus, each patient will have rTMS testing, psychometrics, and EEG recordings. With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module.
Short-term protocol: Use LF-rTMS protocol as described but for up to 5 days in 10 participants with medically refractory status epilepticus. During each session EEG will be recorded.
- Conditions
- Epilepsy, Status Epilepticus, Epilepsia Partialis Continua, Epilepsia Partialis Continua, Refractory (Medically)
- Being tested
- Low frequency repeated TMS (LF-rTMS)
- Medical subject headings
- Epilepsy, Status Epilepticus, Epilepsia Partialis Continua
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency repeated TMS (LF-rTMS)Device
Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Weekly TMS | Experimental | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days) , LF-rTMS 1 session/week for 1 month (4 days), and LF-rTMS 1 session/month for 11 months Receives: Device: Low frequency repeated TMS (LF-rTMS) |
| Group 2: Monthly TMS | Experimental | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months Receives: Device: Low frequency repeated TMS (LF-rTMS) |
| Group 3: Sham TMS | Sham comparator | Sham LF-rTMS for 2 weeks (5 days per week for a total of 10 days), sham LF-rTMS 1 session/week for 1 month (4 days), and sham LF-rTMS 1 session/month for 1 month. After the sham stimulation real LF-rTMS intervention sessions will be delivered as follows: 50% of placebo group will follow group 1 protocol and the other 50% will follow group 2 protocol Receives: Device: Low frequency repeated TMS (LF-rTMS) |
| Short-term protocol | Experimental | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only Receives: Device: Low frequency repeated TMS (LF-rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Weekly Seizure Frequency
Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment.
Measured: 6 and 7 weeks post rTMS treatment
Scalp EEG: Number of Interictal Epileptiform Discharges
Interictal discharges are common in those with epilepsy and tends to decrease with treatment.
Measured: From start of intervention through 5 days of treatment
Seizure Duration Proxy for Seizure Severity
Care provider journaled the seizure duration over the coure of a 2-week period beginning on week 6 post rTMS treatment.
Measured: 6-7-weeks post rTMS treatment
Secondary outcomes (5)
Interhemispheric EEG Asymmetry Ratio for Alpha Power
Expresses the ratio of laterality for the corresponding electrode pairs between the left and right hemispheres, where the left hemisphere electrodes are divided by the right hemisphere electrodes.
Measured: 8-weeks Post rTMS Treatment
Scalp EEG Functional Connectivity for Alpha Hz
Standardized functional scalp EEG connection per of region (anterior, posterior, right, and left). Calculations required EEG electrode activity of 80% for a minimum of 20 epochs to be included. All area electrode counts were then divided by the threshold providing a normalized value per brain region. Scalp EEG connectivity was collected 8-weeks post rTMS treatment.
Measured: 8-weeks Post rTMS Treatment
Abductor Pollicis Brevis (APB)-Evoked Response Threshold
The motor evoked potential (MEP) will be calculated using the Nexstim system's 6-channel EMG module (SR=1450 Hz, cut-off frequency of 350 Hz for the low pass filter) as the APB is stimulated to find the threshold for each individual. Listed values represent the percentage of the maximum Tesla output of the Nexstim system.
Measured: 8-weeks Post rTMS treatment
Treatment Response Rate
Count of subjects whose seizure frequency decreased by 50% after rTMS treatment
Measured: 8-weeks post rTMS treatment
Intrahemispheric EEG Asymmetry Ratio for Alpha Power
Expresses the asymmetry power ratio for the corresponding electrode pairs between the posterior and anterior brain regions, where the left posterior electrodes are divided by the anterior electrodes.
Measured: 8-weeks Post rTMS Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start19 Feb 2016
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation, Florida International University
- Responsible party
- Principal investigator, Alberto Pinzon, M.D., Baptist Health South Florida
- Investigators
- Alberto Pinzon, M.D., Ph.D., Principal investigator, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154307
- Sponsor's protocol ID
- 15-135
- Status last verified
- May 2023
- First submitted
- 10 May 2017
- Last updated
- 23 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.
PubMed 12849236Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
PubMed 10910346Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.
PubMed 17296913Siebner HR, Hartwigsen G, Kassuba T, Rothwell JC. How does transcranial magnetic stimulation modify neuronal activity in the brain? Implications for studies of cognition. Cortex. 2009 Oct;45(9):1035-42. doi: 10.1016/j.cortex.2009.02.007. Epub 2009 Mar 3.
PubMed 19371866Udupa K, Sathyaprabha TN, Thirthalli J, Kishore KR, Raju TR, Gangadhar BN. Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation. J Affect Disord. 2007 Dec;104(1-3):231-6. doi: 10.1016/j.jad.2007.04.002. Epub 2007 May 8.
PubMed 17490754Fox MD, Liu H, Pascual-Leone A. Identification of reproducible individualized targets for treatment of depression with TMS based on intrinsic connectivity. Neuroimage. 2013 Feb 1;66:151-60. doi: 10.1016/j.neuroimage.2012.10.082. Epub 2012 Nov 7.
PubMed 23142067Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.
PubMed 24411682
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated TMS at Low Frequencies to Reduce Seizure Occurrence
- ClinicalTrials.gov ID
- NCT03154307
- Acronym / sponsor ID
- 15-135
- Conditions
- Epilepsy, Status Epilepticus, Epilepsia Partialis Continua, Epilepsia Partialis Continua, Refractory (Medically)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation, Florida International University
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 23 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with the intent to reduce the occurrence of seizures over time (long-term protocol). Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module. Up to 100 individuals 18 to 80 years with epilepsy will be enrolled.
In addition, a short-term protocol has been added to test whether LF-rTMS can reduce or suppress status epilepticus in medically refractory participants.
Detailed description
Long term protocol: Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with to reduce the occurrence of seizures over time. Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). Using a double-blinded, sham-controlled design, we will enroll up to 100 participants aged 18-80 with focal and generalized retractable epilepsy. Baseline data will include a detailed seizure diary over 4 weeks, psychometric testing/neuropsychology evaluation, and 20-minute EEG recordings. Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120%MT, and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. The protocol will be divided in 3 groups (Groups 1, 2 and 3) as follows:
- Groups 1, 2, and 3: LF-rTMS for 2 weeks (5 days per week for total of 10 days).
- Group 1: protocol total duration: 1 year: LF-rTMS 1 session/week for 1 month (4 days), and LF-rTMS 1 session/month for 11 months
- Group 2: protocol total duration: 1 year: LF-rTMS 1 session/month for 12 months
- Group 3 (placebo protocol, total duration: 1 year): LF-rTMS 1 session/week for 1 month (4 days); and LF-rTMS 1session/month.
During each session EEG may be recorded. Also, we will obtain the number, frequency, and duration of seizure events from an ongoing seizure diary. Psychometric testing will be performed at the beginning of study, 3 months, and at the end of the study. Thus, each patient will have rTMS testing, psychometrics, and EEG recordings. With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module.
Short-term protocol: Use LF-rTMS protocol as described but for up to 5 days in 10 participants with medically refractory status epilepticus. During each session EEG will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Weekly TMS | Experimental | Device: Low frequency repeated TMS (LF-rTMS)LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days) , LF-rTMS 1 session/week for 1 month (4 days), and LF-rTMS 1 session/month for 11 months |
| Group 2: Monthly TMS | Experimental | Device: Low frequency repeated TMS (LF-rTMS)LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months |
| Group 3: Sham TMS | Sham comparator | Device: Low frequency repeated TMS (LF-rTMS)Sham LF-rTMS for 2 weeks (5 days per week for a total of 10 days), sham LF-rTMS 1 session/week for 1 month (4 days), and sham LF-rTMS 1 session/month for 1 month. After the sham stimulation real LF-rTMS intervention sessions will be delivered as follows: 50% of placebo group will follow group 1 protocol and the other 50% will follow group 2 protocol |
| Short-term protocol | Experimental | Device: Low frequency repeated TMS (LF-rTMS)LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Experience ≥ 3 seizures/month in the month prior to starting study (any type of seizure will count)
- No status epilepticus in the last 12 months
- No change in medication in last 30 days
- Epilepsia partialis continua or status epilepticus
- At least 2 medications failed
Key exclusion criteria (6 listed)
- Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
- Presence of intracranial metal (e.g., aneurysm clip)
- Unable to cooperate with non-sedated, navigated TMS testing
- Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
- Presence of intracranial metal (e.g., aneurysm clip)
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 |
|---|---|---|
| Low frequency repeated TMS (LF-rTMS)Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group. | Device | Group 1: Weekly TMS, Group 2: Monthly TMS, Group 3: Sham TMS, Short-term protocol |
Primary outcome
Average Weekly Seizure Frequency
Time frame: 6 and 7 weeks post rTMS treatment
Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment.
Scalp EEG: Number of Interictal Epileptiform Discharges
Time frame: From start of intervention through 5 days of treatment
Interictal discharges are common in those with epilepsy and tends to decrease with treatment.
Seizure Duration Proxy for Seizure Severity
Time frame: 6-7-weeks post rTMS treatment
Care provider journaled the seizure duration over the coure of a 2-week period beginning on week 6 post rTMS treatment.
5 secondary outcomes
Interhemispheric EEG Asymmetry Ratio for Alpha Power
Time frame: 8-weeks Post rTMS Treatment
Scalp EEG Functional Connectivity for Alpha Hz
Time frame: 8-weeks Post rTMS Treatment
Abductor Pollicis Brevis (APB)-Evoked Response Threshold
Time frame: 8-weeks Post rTMS treatment
Treatment Response Rate
Time frame: 8-weeks post rTMS treatment
Intrahemispheric EEG Asymmetry Ratio for Alpha Power
Time frame: 8-weeks Post rTMS Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12849236Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.
- Background: PubMed 10910346Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
- Background: PubMed 17296913Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.
- Background: PubMed 19371866Siebner HR, Hartwigsen G, Kassuba T, Rothwell JC. How does transcranial magnetic stimulation modify neuronal activity in the brain? Implications for studies of cognition. Cortex. 2009 Oct;45(9):1035-42. doi: 10.1016/j.cortex.2009.02.007. Epub 2009 Mar 3.
- Background: PubMed 17490754Udupa K, Sathyaprabha TN, Thirthalli J, Kishore KR, Raju TR, Gangadhar BN. Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation. J Affect Disord. 2007 Dec;104(1-3):231-6. doi: 10.1016/j.jad.2007.04.002. Epub 2007 May 8.
- Background: PubMed 23142067Fox MD, Liu H, Pascual-Leone A. Identification of reproducible individualized targets for treatment of depression with TMS based on intrinsic connectivity. Neuroimage. 2013 Feb 1;66:151-60. doi: 10.1016/j.neuroimage.2012.10.082. Epub 2012 Nov 7.
- Background: PubMed 24411682Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.
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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.
Alberto Pinzon, M.D., Ph.D. principal investigator
Baptist Health South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency repeated TMS (LF-rTMS) in people with Epilepsy and Status Epilepticus, run by Baptist Health South Florida at 1 site in United States.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Weekly Seizure Frequency (time frame: 6 and 7 weeks post rTMS treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154307, which also lists 7 linked publications.
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 23 Jun 2023.