Trial Outcomes & Findings for Steps for Epilepsy (NCT NCT05359003)

NCT ID: NCT05359003

Last Updated: 2026-01-08

Results Overview

As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Week 12 to Week 16
• Results posted on: 2026-01-08

Participant Flow

During a 4-week baseline period, the participants will continue their usual activity but will wear the Garmin and ActivPAL 4 and keep a study diary. We will use this to assess their baseline PA profiles and seizure frequency and to screen for adherence with device and diary use, as participants who have <75% complete days of seizure recording or step data via the Garmin will not be randomized.

Participant milestones

Measure	Arm 1: Physical Activity Intervention Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Overall Study STARTED	15	6
Overall Study COMPLETED	14	3
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Arm 1: Physical Activity Intervention Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Steps for Epilepsy

Baseline characteristics by cohort

Measure	Arm 1: Physical Activity Intervention n=15 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)	Total n=21 Participants Total of all reporting groups
Age, Continuous	37.5 years STANDARD_DEVIATION 12.0 • n=18 Participants	33.7 years STANDARD_DEVIATION 7.66 • n=17 Participants	36.41 years STANDARD_DEVIATION 10.89 • n=35 Participants
Sex: Female, Male Female	10 Participants n=18 Participants	3 Participants n=17 Participants	13 Participants n=35 Participants
Sex: Female, Male Male	5 Participants n=18 Participants	3 Participants n=17 Participants	8 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=18 Participants	6 Participants n=17 Participants	21 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	3 Participants n=18 Participants	0 Participants n=17 Participants	3 Participants n=35 Participants
Race (NIH/OMB) White	12 Participants n=18 Participants	5 Participants n=17 Participants	17 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	1 Participants n=17 Participants	1 Participants n=35 Participants

PRIMARY outcome

Timeframe: Week 12 to Week 16

Population: Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only.

As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=15 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence	0.267 Proportion Interval 0.076 to 0.581	—

PRIMARY outcome

Timeframe: Week 24 to Week 28

Population: Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only.

As measured by average daily steps via the Garmin device over the last 4 weeks of the maintenance period, will be calculated and 95% binomial confidence intervals generated.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability	0.143 Proportion Interval 0.018 to 0.423	—

SECONDARY outcome

Timeframe: Week 4

Time spent sedentary during the last week of baseline as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent Sedentary	4790 avg minutes per week spent sedentary Interval 4388.0 to 5194.0	3356 avg minutes per week spent sedentary Interval 1265.0 to 5448.0

SECONDARY outcome

Timeframe: Week 4

Time spent in light intensity in the last week of baseline as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Light Intensity Activity	364 avg minutes per week in light intensity Interval 267.0 to 461.0	297 avg minutes per week in light intensity Interval 239.0 to 355.0

SECONDARY outcome

Timeframe: Week 4

Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Moderate Intensity Activity	99.6 avg minutes per week in moderate Interval 42.4 to 157.0	45 avg minutes per week in moderate Interval 6.88 to 83.1

SECONDARY outcome

Timeframe: Week 4

Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Vigorous Intensity Activity	81.6 avg minutes per week in vigorous Interval 18.6 to 145.0	40.8 avg minutes per week in vigorous Interval -17.8 to 99.4

SECONDARY outcome

Timeframe: Week 28

Population: For the Control Group: 3 dropouts participants did not complete the survey, and 1 participant only partially completed this form. Only 2 were analyzed.

The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=2 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Exit Survey	18.43 score on a scale Standard Deviation 1.95	17.50 score on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Week 16

Population: Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only. Only 13 participants were analyzed because 1 participant dropped out and 1 participant did not complete the survey.

We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=13 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response	9 Participants	—

SECONDARY outcome

Timeframe: Week 16

Time spent sedentary during the last week of intervention as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=2 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent Sedentary	5608 avg minutes per week spent sedentary Interval 5146.0 to 6071.0	5344 avg minutes per week spent sedentary Interval 4699.0 to 5989.0

SECONDARY outcome

Timeframe: Week 28

Time spent sedentary during the last week of maintenance as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=11 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=1 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent Sedentary	4266 avg minutes per week spent sedentary Interval 2977.0 to 5556.0	5697 avg minutes per week spent sedentary cannot calculate CI due to n=1

SECONDARY outcome

Timeframe: Week 16

Time spent in light intensity in the last week of intervention as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=2 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Light Intensity Activity	374 avg minutes per week in light intensity Interval 181.0 to 567.0	355 avg minutes per week in light intensity Interval 50.2 to 659.0

SECONDARY outcome

Timeframe: Week 28

Time spent in light intensity in the last week of maintenance as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=11 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=1 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Light Intensity Activity	305 avg minutes per week in light intensity Interval 109.0 to 501.0	742 avg minutes per week in light intensity cannot calculate CI due to n=1

SECONDARY outcome

Timeframe: Week 16

Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=2 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Moderate Intensity Activity	175 avg minutes per week in moderate Interval -4.19 to 353.0	110 avg minutes per week in moderate Interval 68.8 to 151.0

SECONDARY outcome

Timeframe: Week 28

Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=11 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=1 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Moderate Intensity Activity	179 avg minutes per week in moderate Interval 36.3 to 322.0	141 avg minutes per week in moderate cannot calculate CI due to n=1

SECONDARY outcome

Timeframe: Week 16

Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=14 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=2 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Vigorous Intensity Activity	61.7 avg minutes per week in vigorous Interval 13.9 to 110.0	156 avg minutes per week in vigorous Interval -18.9 to 332.0

SECONDARY outcome

Timeframe: Week 28

Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch.

Outcome measures

Measure	Arm 1: Physical Activity Intervention n=11 Participants Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=1 Participants Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)
Time Spent in Vigorous Intensity Activity	57.3 avg minutes per week in vigorous Interval 17.8 to 96.7	160 avg minutes per week in vigorous cannot calculate CI due to n=1

Adverse Events

Arm 1: Exercise Intervention

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 2: Control

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: Exercise Intervention n=15 participants at risk Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). 12-week physical activity program: Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 participants at risk Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.
Injury, poisoning and procedural complications Fall with injury that required medical attention	13.3% 2/15 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Cardiac disorders Dizziness that resulted in ER visit	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Musculoskeletal and connective tissue disorders Weakness that resulted in ER visit	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Nervous system disorders Planned admission for electrode implant placement	0.00% 0/15 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	16.7% 1/6 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"

Other adverse events

Measure	Arm 1: Exercise Intervention n=15 participants at risk Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). 12-week physical activity program: Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.	Arm 2: Control n=6 participants at risk Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.
Skin and subcutaneous tissue disorders Skin irritation at site of activity monitor	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	33.3% 2/6 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Nervous system disorders Seizure with minor injury (not during exercise)	13.3% 2/15 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	16.7% 1/6 • Number of events 3 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
General disorders Dizziness and vomiting	0.00% 0/15 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	16.7% 1/6 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
General disorders Bumped into furniture	13.3% 2/15 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	16.7% 1/6 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Nervous system disorders Seizure frequency increased	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Psychiatric disorders Depression episode	13.3% 2/15 • Number of events 2 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Nervous system disorders Headache or migraine	20.0% 3/15 • Number of events 3 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Musculoskeletal and connective tissue disorders Joint pain	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Renal and urinary disorders Kidney stone	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Skin and subcutaneous tissue disorders Lipoma	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Skin and subcutaneous tissue disorders Lupus	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Injury, poisoning and procedural complications Minor fall	40.0% 6/15 • Number of events 8 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
General disorders Strep throat	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Nervous system disorders Seizure within 30 min of physical activity	13.3% 2/15 • Number of events 4 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
Surgical and medical procedures Routine surgery to replace battery medical device	6.7% 1/15 • Number of events 1 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"	0.00% 0/6 • 7 months (Day 0 - Week 28) Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily. All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"

Additional Information

Halley Alexander, MD, MS, FACNS

Wake Forest University School of Medicine

Phone: 336-716-6898

Email: halley.alexander@advocatehealth.org

Results disclosure agreements

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