Trial Outcomes & Findings for Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS) (NCT NCT01745952)

NCT ID: NCT01745952

Last Updated: 2023-05-11

Results Overview

Number of participants achieving a 50% or greater reduction in seizure frequency from baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: week 12 after each intervention
• Results posted on: 2023-05-11

Participant Flow

Participant milestones

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Overall Study STARTED	4	4	3
Overall Study COMPLETED	3	3	3
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)

Baseline characteristics by cohort

Measure	All Participants n=11 Participants description of the patients at the onset of the study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
baseline seizure frequency per week	24.9 seizures/week n=5 Participants

PRIMARY outcome

Timeframe: week 12 after each intervention

Population: Besides the reported participants that went through whole protocol, one supplementary participant underwent the first rTMS session of the first protocol and one supplementary participant underwent the first rTMS session of the second protocol

Number of participants achieving a 50% or greater reduction in seizure frequency from baseline

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=3 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=2 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=3 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment 50% seizure reduction over any of three periods	0 participants	0 participants	0 participants
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment 50% seizure reduction over whole study	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: week 12 after each treatment

Population: baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)

Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=8 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=9 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=7 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment	25.7 seizures/week Interval 7.4 to 89.4	23.5 seizures/week Interval 7.2 to 76.2	28.6 seizures/week Interval 8.2 to 99.8

OTHER_PRE_SPECIFIED outcome

Timeframe: within one week after the last treatment day of each session

Population: patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as "ineffective")

Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=9 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=10 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=9 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level hypermetabolism compared to baseline	1 participants	3 participants	2 participants
Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level hypometabolism compared to baseline	3 participants	3 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: averaged weekly seizure count per condition is given for all patients combined

any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=10 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Difference in Seizure Reduction Using Different Coil Types seizures in condition 1 (baseline)	25 number of seizures per week Interval 8.0 to 76.0	—	—
Difference in Seizure Reduction Using Different Coil Types seizures in condition 2 (figure-8)	26 number of seizures per week Interval 7.0 to 89.0	—	—
Difference in Seizure Reduction Using Different Coil Types seizures in condition 3 (round)	24 number of seizures per week Interval 7.0 to 76.0	—	—
Difference in Seizure Reduction Using Different Coil Types seizures in condition 4 (sham)	29 number of seizures per week Interval 8.0 to 100.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: before the first treatment of each session and at the last evaluation visit

Population: \* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively

• Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.
• Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment
• Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk
• change in QOLIE scores considered better/worse are based on cut-off reported in "DOI 10.1016/j.yebeh.2011.12.023" For global impression of change, the scoring was <4, 4 or >4.

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=5 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=6 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=5 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale Global impression of change: better	1 participants	1 participants	0 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale better QOLIE score	3 participants	3 participants	1 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale worse QOLIE score	0 participants	1 participants	1 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale Global impression of change: no change	4 participants	5 participants	5 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale Global impression of change: worse	1 participants	1 participants	1 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale Global impression change: first better, then worse	1 participants	1 participants	0 participants
Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale CSSR-scale increased suicidality	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during the 9 months of the study

Population: for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters

exclusion by investigator was due to necessity to change drug regimen due to toxicity

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=4 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=4 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=3 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Drop Out-rate excluded by investigator from concluding study	0 participants	1 participants	0 participants
Drop Out-rate stopped due to intolerance/ inefficiency	0 participants	1 participants	0 participants
Drop Out-rate stopped due to seizure worsening	1 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during the 9 months of the study

Outcome measures

Measure	Figure-of-eight Active Coil; Then Round Active Coil; Then Sham n=9 Participants * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Round Active Coil; Then Sham; Then Figure-of-eight Active Coil n=10 Participants * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period	Sham Coil; Then Figure-of-eight Active Coil; Then Round Active n=8 Participants * rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period * rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. * 12 week follow-up period
Adverse Event Rate worsening seizures	2 participants	1 participants	0 participants
Adverse Event Rate hearing problems	1 participants	1 participants	0 participants
Adverse Event Rate fatigue	2 participants	2 participants	2 participants
Adverse Event Rate concentration difficulties	1 participants	1 participants	1 participants

Adverse Events

Figure-of-eight Active rTMS Coil

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Round Active rTMS Coil

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Sham rTMS Coil (Figure-of-eight)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Figure-of-eight Active rTMS Coil n=9 participants at risk rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil	Round Active rTMS Coil n=10 participants at risk rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil	Sham rTMS Coil (Figure-of-eight) n=9 participants at risk rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
Nervous system disorders seizure excacerbation	22.2% 2/9 • 9-month study duration	10.0% 1/10 • 9-month study duration	0.00% 0/9 • 9-month study duration

Other adverse events

Measure	Figure-of-eight Active rTMS Coil n=9 participants at risk rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil	Round Active rTMS Coil n=10 participants at risk rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil	Sham rTMS Coil (Figure-of-eight) n=9 participants at risk rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
Nervous system disorders fatigue, concentration difficulties	33.3% 3/9 • 9-month study duration	30.0% 3/10 • 9-month study duration	33.3% 3/9 • 9-month study duration

Additional Information

Prof W Van Paesschen & Dr L Seynaeve

UZ Leuven

Phone: +3216349062

Email: laura.seynaeve@uzleuven.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place