Trial Outcomes & Findings for Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy (NCT NCT01910129)

NCT ID: NCT01910129

Last Updated: 2019-04-23

Results Overview

The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	gammaCore Then Sham gammaCore 8 weeks active stimulation with the gammaCore device , no wash out , followed by 8 weeks sham treatment with the sham device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore Then gammaCore 8 weeks sham treatment with the sham device, no wash -out, followed by 8 weeks sham treatment with the with the gammaCore device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart	Run-in Period Not randomized or allocated to treatment group
Run-in Period Phase 1 STARTED	0	0	13
Run-in Period Phase 1 COMPLETED	0	0	13
Run-in Period Phase 1 NOT COMPLETED	0	0	0
Randomized Phase 2 STARTED	7	6	0
Randomized Phase 2 COMPLETED	5	5	0
Randomized Phase 2 NOT COMPLETED	2	1	0
Randomized Phase 3 STARTED	5	5	0
Randomized Phase 3 COMPLETED	5	4	0
Randomized Phase 3 NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	gammaCore Then Sham gammaCore 8 weeks active stimulation with the gammaCore device , no wash out , followed by 8 weeks sham treatment with the sham device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore Then gammaCore 8 weeks sham treatment with the sham device, no wash -out, followed by 8 weeks sham treatment with the with the gammaCore device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart	Run-in Period Not randomized or allocated to treatment group
Randomized Phase 2 Withdrawal by Subject	2	1	0
Randomized Phase 3 Withdrawal by Subject	0	1	0

Baseline Characteristics

Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	gammaCore Then Sham gammaCore n=7 Participants 8 weeks Active gammaCore stimulation treatment followed by 8 weeks sham (inactive) gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore Then gammaCore n=6 Participants 8 weeks sham (inactive) gammaCore treatment followed by 8 weeks active gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Total n=13 Participants Total of all reporting groups
Age, Continuous	43 years n=5 Participants	59 years n=7 Participants	51 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Indian (Fiji)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Australia	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: safety population 3 subjects were missing data in phase 3 (2 from phase 2 active group and 1 from the phase 2 sham group)

The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

Outcome measures

Outcome measures
Measure	gammaCore Then Sham gammaCore n=7 Participants Active gammaCore stimulation treatment followed by sham gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore the gammaCore n=6 Participants Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 2 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart	gammaCore Phase 3 gammaCore stimulation treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 3 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart
Frequency of Seizures Frequency of Seizure Phase 2	9.1 seizures Interval 2.0 to 17.0	8.2 seizures Interval 2.0 to 21.0	—	—	—
Frequency of Seizures Frequency of Seizure Phase 3	9.4 seizures Interval 2.0 to 17.0	6.6 seizures Interval 0.0 to 12.0	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Safety population. One subject has missing data in the active gammacore group. 2 subjects were missing data in phase 3 (1 from phase 2 active group and 1 from the phase 2 sham group) 1 subject in the phase 3 sham group reported 0 seizures during this phase

Duration of seizure was recorded by the subject in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

Outcome measures

Outcome measures
Measure	gammaCore Then Sham gammaCore n=6 Participants Active gammaCore stimulation treatment followed by sham gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore the gammaCore n=6 Participants Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 2 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart	gammaCore Phase 3 gammaCore stimulation treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 3 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart
Duration of Seizure Duration of Seizure Phase 2	4.5 minutes Standard Deviation 4.3	6.5 minutes Standard Deviation 10.7	—	—	—
Duration of Seizure Duration of Seizure Phase 3	6.0 minutes Standard Deviation 8.5	5.9 minutes Standard Deviation 7.2	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Safety population. 4 subjects were missing data (one in the gammacore group and 3 in the sham group) 3 subjects in the gammacore group were missing data in phase 3

The Seizure Severity Questionnaire (SSQ) is a self-reported assessment tool, which categorizes seizures into three phases: warning, ictal activity and postictal recovery. The recovery phase is subdivided into three components (cognitive, emotional and physical aspects of recovery), each of which is rated for frequency, severity and bothersome. Overall assessment of seizure severity is measured with the last two items. Items are positively scored from a scale of 1-7, with lower scores representing a better status. 1 = none, never or mild and 7 = extremely frequent, severe or high. The severity was reported for seizures occuring throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

Outcome measures

Outcome measures
Measure	gammaCore Then Sham gammaCore n=6 Participants Active gammaCore stimulation treatment followed by sham gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore the gammaCore n=3 Participants Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 2 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart	gammaCore Phase 3 gammaCore stimulation treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 3 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart
Severity of Seizure Severity of Seizure Phase 2	4.0 units on a scale Standard Deviation 2.14	2.8 units on a scale Standard Deviation 2.24	—	—	—
Severity of Seizure Severity of Seizure Phase 3	4.8 units on a scale Standard Deviation 2.70	4.0 units on a scale Standard Deviation 1.49	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Safety population.

Type of adverse events were split in to Adverse Events, Adverse Device Effects and Serious Adverse Events. Adverse events were reported throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks). For frequency see the Adverse Event Table.

Outcome measures

Outcome measures
Measure	gammaCore Then Sham gammaCore n=13 Participants Active gammaCore stimulation treatment followed by sham gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore the gammaCore n=7 Participants Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 2 n=6 Participants sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart	gammaCore Phase 3 n=5 Participants gammaCore stimulation treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 3 n=5 Participants sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart
Type of Adverse Events Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Type of Adverse Events Adverse Device Effect	0 Participants	5 Participants	4 Participants	2 Participants	2 Participants
Type of Adverse Events Adverse Events	6 Participants	5 Participants	4 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Safety population. 1 subject was missing data in the gammacore group. 1 subject from phase 2 gammacore group and 1 subject from the phase 2 sham group were missing data in phase 3

The number of seizure-free days was collected from the subjects' diary. The total number of days observed days for each phase and the total number of seizure free days for each phase are presented for the course of the study throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

Outcome measures

Outcome measures
Measure	gammaCore Then Sham gammaCore n=6 Participants Active gammaCore stimulation treatment followed by sham gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham gammaCore the gammaCore n=6 Participants Inactive sham gammaCore stimulation treatment followed by Active gammaCore stimulation gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 2 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart	gammaCore Phase 3 gammaCore stimulation treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart	Sham Phase 3 sham gammaCore stimulation treatment sham stimulation 3 times a day 8 hours apart
Number of Seizure Free Days Phase 2 Number of observed days (total)	295 days	281 days	—	—	—
Number of Seizure Free Days Phase 2 Number of observed seizure free days	257 days	245 days	—	—	—
Number of Seizure Free Days Phase 3 Number of observed days (total)	296 days	270 days	—	—	—
Number of Seizure Free Days Phase 3 Number of observed seizure free days	255 days	244 days	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Safety population. 2 subject in the gammacore group and 1 subject in the sham group were missing data. 1 subject in the gammacore group was missing data in phase 3

The Quality of Life in Epilepsy-31 (QOLIE-31) instrument is a self- administered questionnaire. It includes seven subscales: Overall Quality of Life, Seizure Worry, Emotional Well-Being, Energy/Fatigue, Cognitive, Medication Effects, and Social Function. Questions 1-30 can yield seven individual scores (per subtest) and a total (composite) score. Higher scores indicate better QOL with values ranging from 1 to 100. Question 31 is a subjective assessment of one's general health condition.Higher scores indicate a better-reported general health condition with the range being 1-10. Scores are presented at end of Intervention 1/Phase 2 (8 weeks) and at the end of Intervention 2/Phase 3 (8 weeks).