Trial Outcomes & Findings for Repeated TMS at Low Frequencies to Reduce Seizure Occurrence (NCT NCT03154307)
NCT ID: NCT03154307
Last Updated: 2023-06-23
Results Overview
Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
6 and 7 weeks post rTMS treatment
Results posted on
2023-06-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
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|---|---|---|---|---|
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Overall Study
STARTED
|
2
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
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0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
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0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline data was not fully collected for 1 patient who withdrew from the study.
Baseline characteristics by cohort
| Measure |
Group 1: Weekly TMS
n=1 Participants
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.
|
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.
|
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.
|
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Baseline Seizure frequency per week
|
37 seizures per week
n=5 Participants • Baseline data was not fully collected for 1 patient who withdrew from the study.
|
—
|
—
|
—
|
37 seizures per week
n=21 Participants • Baseline data was not fully collected for 1 patient who withdrew from the study.
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Anterior
|
2.44 Standardized EEG connections
n=5 Participants
|
—
|
—
|
—
|
2.44 Standardized EEG connections
n=21 Participants
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Posterior
|
1.0 Standardized EEG connections
n=5 Participants
|
—
|
—
|
—
|
1.0 Standardized EEG connections
n=21 Participants
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Right
|
2.425 Standardized EEG connections
n=5 Participants
|
—
|
—
|
—
|
2.425 Standardized EEG connections
n=21 Participants
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Left
|
0.63 Standardized EEG connections
n=5 Participants
|
—
|
—
|
—
|
0.63 Standardized EEG connections
n=21 Participants
|
|
Baseline Seizure Duration Proxy for Seizure Severity
|
26.08 seconds
STANDARD_DEVIATION 28.97 • n=5 Participants
|
—
|
—
|
—
|
26.08 seconds
STANDARD_DEVIATION 28.97 • n=21 Participants
|
|
Abductor Pollicis Brevis (APB)-evoked response threshold
|
40 percentage of max Telsa
n=5 Participants
|
—
|
—
|
—
|
40 percentage of max Telsa
n=21 Participants
|
|
Interhemispheric EEG Asymmetry Ratio for Alpha power
|
1.26 Ratio
n=5 Participants
|
—
|
—
|
—
|
1.26 Ratio
n=21 Participants
|
|
Intrahemispheric EEG Asymmetry Ratio for Alpha power
|
1.28 Ratio
n=5 Participants
|
—
|
—
|
—
|
1.28 Ratio
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 and 7 weeks post rTMS treatmentPopulation: Post rTMS seizure journal
Seizure frequency was recorded by the caregiver in a journal at weeks 6 and 7 post rTMS treatment.
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=44 seizures
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.
|
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.
|
|---|---|---|---|---|
|
Average Weekly Seizure Frequency
|
—
|
—
|
22 average seizure frequency per week
Interval 21.0 to 23.0
|
—
|
PRIMARY outcome
Timeframe: From start of intervention through 5 days of treatmentPopulation: No interictal discharges were observed during baseline or post-treatment.
Interictal discharges are common in those with epilepsy and tends to decrease with treatment.
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Scalp EEG: Number of Interictal Epileptiform Discharges
|
—
|
—
|
0 Interictal discharges
|
—
|
PRIMARY outcome
Timeframe: 6-7-weeks post rTMS treatmentPopulation: Post rTMS seizure journal
Care provider journaled the seizure duration over the coure of a 2-week period beginning on week 6 post rTMS treatment.
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=44 seizures
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.
|
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.
|
|---|---|---|---|---|
|
Seizure Duration Proxy for Seizure Severity
|
—
|
—
|
34.54 seconds
Standard Deviation 26.14
|
—
|
SECONDARY outcome
Timeframe: 8-weeks Post rTMS TreatmentPopulation: left hemisphere electrodes are divided by the right hemisphere electrodes
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.
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Interhemispheric EEG Asymmetry Ratio for Alpha Power
|
—
|
—
|
0.45 Ratio
|
—
|
SECONDARY outcome
Timeframe: 8-weeks Post rTMS TreatmentPopulation: Data was based on standardized threshold of 80% across 20 Epochs
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.
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=1 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Scalp EEG Functional Connectivity for Alpha Hz
Anterior
|
—
|
—
|
0.4 Standardized EEG connections
|
—
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Posterior
|
—
|
—
|
0.455 Standardized EEG connections
|
—
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Right
|
—
|
—
|
0.375 Standardized EEG connections
|
—
|
|
Scalp EEG Functional Connectivity for Alpha Hz
Left
|
—
|
—
|
0.255 Standardized EEG connections
|
—
|
SECONDARY outcome
Timeframe: 8-weeks Post rTMS treatmentPopulation: Post APB-evoked response was not collected, therefore cannot be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-weeks post rTMS treatmentPopulation: 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.
Count of subjects whose seizure frequency decreased by 50% after rTMS treatment
Outcome measures
| Measure |
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.
|
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.
|
Group 1: Weekly TMS
n=1 Participants
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.
|
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.
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|---|---|---|---|---|
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Treatment Response Rate
Responder (> 50%)
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—
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—
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0 Participants
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—
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Treatment Response Rate
Non-Responder (<50%)
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—
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—
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1 Participants
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—
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SECONDARY outcome
Timeframe: 8-weeks Post rTMS TreatmentPopulation: left posterior electrodes are divided by the anterior electrodes
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.
Outcome measures
| Measure |
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.
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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.
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Group 1: Weekly TMS
n=1 Participants
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.
|
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.
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|---|---|---|---|---|
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Intrahemispheric EEG Asymmetry Ratio for Alpha Power
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—
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—
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0.095 Ratio
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—
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Adverse Events
Group 1: Weekly TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Monthly TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Sham TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short-term Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Administrator
Miami Neuroscience Institute
Phone: 17865961825
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place