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Low Recruitment
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| Name | Class |
|---|---|
| U.S. National Science Foundation | FED |
| Florida International University | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Short-term protocol | Experimental | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Weekly Seizure Frequency | Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment. | 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. | 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. | 6-7-weeks post rTMS treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8-weeks Post rTMS Treatment |
| Scalp EEG Functional Connectivity for Alpha Hz |
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Long-term protocol:
Inclusion Criteria:
Exclusion Criteria:
Short-term protocol:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Pinzon, M.D., Ph.D. | Baptist Health South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12849236 | Background | 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. | |
| 10910346 | Background | Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Weekly TMS | 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 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. |
| FG001 | Group 2: Monthly TMS | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months 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. |
| FG002 | Group 3: Sham TMS | 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 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. |
| FG003 | Short-term Protocol | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was terminated due to low enrollment. No analysis was completed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Weekly TMS | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Weekly Seizure Frequency | Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment. | Post rTMS seizure journal | Posted | Mean | Full Range | average seizure frequency per week | 6 and 7 weeks post rTMS treatment | seizures | seizures |
|
1 year
Study was terminated due to low enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Weekly TMS | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Administrator | Miami Neuroscience Institute | 17865961825 | starlieb@baptisthealth.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Oct 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D013226 | Status Epilepticus |
| D017036 | Epilepsia Partialis Continua |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012640 | Seizures |
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Participant and outcomes assessor will be masked in the 3 arms of the long-term protocol. However, the short-term arm will be open label.
|
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. |
| 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. | 8-weeks Post rTMS treatment |
| Treatment Response Rate | Count of subjects whose seizure frequency decreased by 50% after rTMS treatment | 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. | 8-weeks Post rTMS Treatment |
| 17296913 | Background | Rossini 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. |
| 19371866 | Background | Siebner 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. |
| 17490754 | Background | Udupa 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. |
| 23142067 | Background | Fox 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. |
| 24411682 | Background | Plewnia 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. |
| BG001 | Group 2: Monthly TMS | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months 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. |
| BG002 | Group 3: Sham TMS | 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 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. |
| BG003 | Short-term Protocol | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Seizure frequency per week | Data was collected by caregiver for 2-weeks prior to receiving rTMS treatment to establish a weekly seizure frequency. | Baseline data was not fully collected for 1 patient who withdrew from the study. | Mean | Full Range | seizures per week |
|
| Scalp EEG Functional Connectivity for Alpha Hz | Baseline Standardized functional scalp EEG connection per of region (anterior, posterior, right, 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. | Number | Standardized EEG connections |
|
| Baseline Seizure Duration Proxy for Seizure Severity | Care provider journaled the seizure duration over the course of a 2-week period prior to receiving rTMS treatment to establish baseline seizure severity. | Mean | Standard Deviation | seconds |
|
| 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. | Number | percentage of max Telsa |
|
| 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. | Number | Ratio |
|
| 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. | Number | Ratio |
|
| OG001 | Group 2: Monthly TMS | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months 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. |
| OG002 | Group 3: Sham TMS | 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 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. |
| OG003 | Short-term Protocol | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only 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. |
|
|
| Primary | Scalp EEG: Number of Interictal Epileptiform Discharges | Interictal discharges are common in those with epilepsy and tends to decrease with treatment. | No interictal discharges were observed during baseline or post-treatment. | Posted | Number | Interictal discharges | From start of intervention through 5 days of treatment |
|
|
|
| Primary | 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. | Post rTMS seizure journal | Posted | Mean | Standard Deviation | seconds | 6-7-weeks post rTMS treatment | seizures | seizures |
|
|
|
| Secondary | 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. | left hemisphere electrodes are divided by the right hemisphere electrodes | Posted | Number | Ratio | 8-weeks Post rTMS Treatment |
|
|
|
| Secondary | 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. | Data was based on standardized threshold of 80% across 20 Epochs | Posted | Number | Standardized EEG connections | 8-weeks Post rTMS Treatment |
|
|
|
| Secondary | 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. | Post APB-evoked response was not collected, therefore cannot be analyzed. | Posted | 8-weeks Post rTMS treatment |
|
|
| Secondary | Treatment Response Rate | Count of subjects whose seizure frequency decreased by 50% after rTMS treatment | The only subject to complete the study was assigned the group 1. Due to lack of enrollment no subjects were assigned to group 2, 3, or the short-term group. | Posted | Count of Participants | Participants | 8-weeks post rTMS treatment |
|
|
|
| Secondary | 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. | left posterior electrodes are divided by the anterior electrodes | Posted | Number | Ratio | 8-weeks Post rTMS Treatment |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Group 2: Monthly TMS | LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Group 3: Sham TMS | 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 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Short-term Protocol | LF-rTMS intervention daily for up to 5 days in medically refractory status epilepticus participants only 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| seizures |
|
| Title | Measurements |
|---|
|
| Left |
|