Trial Outcomes & Findings for Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA (NCT NCT05710640)
NCT ID: NCT05710640
Last Updated: 2025-11-25
Results Overview
The JIA ACR 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 50 is achieved if 3 of any 6 core set variables improved by at least 50% from Baseline, and no more than 1 variable worsens by \>30%. A negative change from Baseline in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at Week 8 are imputed as JIA ACR 50 non-responders at Week 8.
TERMINATED
PHASE2
18 participants
Week 8
2025-11-25
Participant Flow
Participant milestones
| Measure |
Active tcVNS
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigational device at the cymba concha through Week 16.
|
Sham Stimulation
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Active tcVNS
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigational device at the cymba concha through Week 16.
|
Sham Stimulation
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Withdrew prior to first device stimulation
|
1
|
0
|
Baseline Characteristics
Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA
Baseline characteristics by cohort
| Measure |
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
12 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=45 Participants
|
9 Participants
n=12929 Participants
|
17 Participants
n=6349 Participants
|
|
JIA Subtype
Rheumatoid-factor negative polyarthritis
|
5 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
11 Participants
n=6349 Participants
|
|
JIA Subtype
Rheumatoid-factor positive polyarthritis
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
JIA Subtype
Enthesitis-related arthritis
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
JIA Subtype
Persistent oligoarthritis
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
JIA Subtype
Extended oligoarthritis
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
JIA Subtype
Psoriatic arthritis
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Continuous
|
13.1 years
STANDARD_DEVIATION 3.36 • n=45 Participants
|
14.1 years
STANDARD_DEVIATION 3.37 • n=12929 Participants
|
13.6 years
STANDARD_DEVIATION 3.30 • n=6349 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
13 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
11 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
JIA Subtype
Systemic arthritis
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Number of Joints with Active Arthritis
|
9.5 Joints
STANDARD_DEVIATION 6.48 • n=45 Participants
|
8.2 Joints
STANDARD_DEVIATION 3.60 • n=12929 Participants
|
8.8 Joints
STANDARD_DEVIATION 5.03 • n=6349 Participants
|
|
Number of Joints with Limited Motion
|
4.1 Joints
STANDARD_DEVIATION 6.92 • n=45 Participants
|
4.6 Joints
STANDARD_DEVIATION 3.17 • n=12929 Participants
|
4.4 Joints
STANDARD_DEVIATION 5.10 • n=6349 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 50 is achieved if 3 of any 6 core set variables improved by at least 50% from Baseline, and no more than 1 variable worsens by \>30%. A negative change from Baseline in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at Week 8 are imputed as JIA ACR 50 non-responders at Week 8.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Week 8 Compared to Baseline
|
0.333 Proportion of Participants
Interval 0.075 to 0.701
|
0.250 Proportion of Participants
Interval 0.032 to 0.651
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 50 is achieved if 3 of any 6 core set variables improved by at least 50% from Baseline, and no more than 1 variable worsens by \>30%. A negative change from Baseline in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 50 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Weeks 4, 12, and 16 Compared to Baseline
Week 4
|
0.111 Proportion of participants
Interval 0.003 to 0.482
|
0.375 Proportion of participants
Interval 0.085 to 0.755
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Weeks 4, 12, and 16 Compared to Baseline
Week 12
|
0.444 Proportion of participants
Interval 0.137 to 0.788
|
0.625 Proportion of participants
Interval 0.245 to 0.915
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Weeks 4, 12, and 16 Compared to Baseline
Week 16
|
0.556 Proportion of participants
Interval 0.212 to 0.863
|
0.625 Proportion of participants
Interval 0.245 to 0.915
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 30 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 30 is achieved if 3 of any 6 core set variables improved by at least 30% from Baseline, and no more than 1 variable worsens by \>30%. A negative change from Baseline in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 30 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 4, 8, 12, and 16 Compared to Baseline
Week 4
|
0.556 Proportion of participants
Interval 0.212 to 0.863
|
0.500 Proportion of participants
Interval 0.157 to 0.843
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 4, 8, 12, and 16 Compared to Baseline
Week 8
|
0.444 Proportion of participants
Interval 0.137 to 0.788
|
0.375 Proportion of participants
Interval 0.085 to 0.755
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 4, 8, 12, and 16 Compared to Baseline
Week 12
|
0.556 Proportion of participants
Interval 0.212 to 0.863
|
0.750 Proportion of participants
Interval 0.349 to 0.968
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 4, 8, 12, and 16 Compared to Baseline
Week 16
|
0.667 Proportion of participants
Interval 0.299 to 0.925
|
0.875 Proportion of participants
Interval 0.473 to 0.997
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 70 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 70 is achieved if 3 of any 6 core set variables improved by at least 70% from Baseline, and no more than 1 variable worsens by \>30%. A negative change from Baseline in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 70 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 4, 8, 12, and 16 Compared to Baseline
Week 4
|
0.111 Proportion of participants
Interval 0.003 to 0.482
|
0.125 Proportion of participants
Interval 0.003 to 0.527
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 4, 8, 12, and 16 Compared to Baseline
Week 8
|
0.111 Proportion of participants
Interval 0.003 to 0.482
|
0.125 Proportion of participants
Interval 0.003 to 0.527
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 4, 8, 12, and 16 Compared to Baseline
Week 12
|
0.333 Proportion of participants
Interval 0.075 to 0.701
|
0.250 Proportion of participants
Interval 0.032 to 0.651
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 4, 8, 12, and 16 Compared to Baseline
Week 16
|
0.333 Proportion of participants
Interval 0.075 to 0.701
|
0.500 Proportion of participants
Interval 0.157 to 0.843
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 8, 12, 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JADAS-27 is a measurement of disease activity and is determined by adding the scores of its 4 components: physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); number of joints with active arthritis; and a laboratory measure of inflammation, c-Reactive Protein (CRP), normalized to a value between 0 and 10. The JADAS-27 includes the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal inter-phalangeal joints, hips, knees, and ankles. This provides a score in the range of 0-57 with higher scores indicating worse disease activity. A negative change from Baseline signifies improvement.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Change From Baseline in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27) at Weeks 4, 8, 12, and 16
Week 8
|
-3.657 Score on a scale
Interval -7.312 to -0.003
|
-5.463 Score on a scale
Interval -9.624 to -1.303
|
|
Change From Baseline in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27) at Weeks 4, 8, 12, and 16
Week 4
|
-2.350 Score on a scale
Interval -6.366 to 1.666
|
-5.187 Score on a scale
Interval -9.741 to -0.633
|
|
Change From Baseline in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27) at Weeks 4, 8, 12, and 16
Week 12
|
-7.607 Score on a scale
Interval -10.297 to -4.917
|
-9.647 Score on a scale
Interval -12.525 to -6.768
|
|
Change From Baseline in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27) at Weeks 4, 8, 12, and 16
Week 16
|
-6.256 Score on a scale
Interval -9.568 to -2.943
|
-9.722 Score on a scale
Interval -13.267 to -6.178
|
SECONDARY outcome
Timeframe: Week 12 and 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 50 is achieved if 3 of any 6 core set variables improved by at least 50% from Week 8, and no more than 1 variable worsens by \>30%. A negative change from Week 8 in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 50 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Weeks 12 and 16 Compared to Week 8
Week 12
|
0.444 Proportion of Participants
Interval 0.137 to 0.788
|
0.125 Proportion of Participants
Interval 0.003 to 0.527
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Responders at Weeks 12 and 16 Compared to Week 8
Week 16
|
0.333 Proportion of Participants
Interval 0.075 to 0.701
|
0.250 Proportion of Participants
Interval 0.032 to 0.651
|
SECONDARY outcome
Timeframe: At Weeks 12 and 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 30 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 30 is achieved if 3 of any 6 core set variables improved by at least 30% from Week 8, and no more than 1 variable worsens by \>30%. A negative change from Week 8 in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 30 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 12 and 16 Compared to Week 8
Week 12
|
0.556 Proportion of Participants
Interval 0.212 to 0.863
|
0.250 Proportion of Participants
Interval 0.032 to 0.651
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Responders at Weeks 12 and 16 Compared to Week 8
Week 16
|
0.333 Proportion of Participants
Interval 0.075 to 0.701
|
0.375 Proportion of Participants
Interval 0.085 to 0.755
|
SECONDARY outcome
Timeframe: Weeks 12 and 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JIA ACR 70 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis; number of joints with limited motion; physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); a validated measure of physical function, Childhood Health Assessment Questionnaire (CHAQ); and a laboratory measure of inflammation, c-Reactive Protein (CRP). The JIA ACR 70 is achieved if 3 of any 6 core set variables improved by at least 70% from Week 8, and no more than 1 variable worsens by \>30%. A negative change from Week 8 in any of the core set variables signifies improvement. Participants missing any of the JIA ACR core criteria at any visit are imputed as JIA ACR 70 non-responders at that visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 12 and 16 Compared to Week 8
Week 12
|
0.111 Proportion of Participants
Interval 0.003 to 0.482
|
0.000 Proportion of Participants
Interval 0.0 to 0.369
|
|
Proportion of Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Responders at Week 12 and 16 Compared to Week 8
Week 16
|
0.222 Proportion of Participants
Interval 0.028 to 0.6
|
0.000 Proportion of Participants
Interval 0.0 to 0.369
|
SECONDARY outcome
Timeframe: Weeks 12 and 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JADAS-27 is a measurement of disease activity and is determined by adding the scores of its 4 components: physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); number of joints with active arthritis; and a laboratory measure of inflammation, c-Reactive Protein (CRP) normalized to a value between 0-10. The JADAS-27 includes the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal inter-phalangeal joints, hips, knees, and ankles. This provides a score in the range of 0-57 with higher scores indicating worse disease activity. A negative change from Week 8 signifies improvement.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Change From Week 8 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 12
|
-4.334 Score on a scale
Interval -6.653 to -2.015
|
-5.216 Score on a scale
Interval -7.705 to -2.728
|
|
Change From Week 8 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 16
|
-3.053 Score on a scale
Interval -6.173 to 0.068
|
-5.211 Score on a scale
Interval -8.559 to -1.863
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 8, 12, 16Population: The modified Intent-to-Treat (mITT) population included all randomized participants who received any active tcVNS stimulation or sham stimulation.
The JADAS-27 is a measurement of disease activity and is determined by adding the scores of its 4 components: physician's assessment of disease activity (measured on a 10 cm visual analogue scale (VAS)); parent/patient assessment of overall well-being (measured on a 10 cm VAS); number of joints with active arthritis; and a laboratory measure of inflammation, c-Reactive Protein (CRP) normalized to a value between 0-10. The JADAS-27 includes the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal inter-phalangeal joints, hips, knees, and ankles. This provides a score in the range of 0-57 with higher scores indicating worse disease activity.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Longitudinal Trends From Baseline to Week 16 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Baseline
|
15.729 Score on a scale
Standard Error 1.6774
|
16.200 Score on a scale
Standard Error 2.5385
|
|
Longitudinal Trends From Baseline to Week 16 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 4
|
13.445 Score on a scale
Standard Error 2.2339
|
10.957 Score on a scale
Standard Error 2.7589
|
|
Longitudinal Trends From Baseline to Week 16 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 8
|
11.767 Score on a scale
Standard Error 1.9662
|
8.686 Score on a scale
Standard Error 1.8442
|
|
Longitudinal Trends From Baseline to Week 16 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 12
|
7.150 Score on a scale
Standard Error 1.8689
|
4.331 Score on a scale
Standard Error 0.8174
|
|
Longitudinal Trends From Baseline to Week 16 in Juvenile Arthritis Disease Activity Score in 27 Joints (JADAS-27)
Week 16
|
8.638 Score on a scale
Standard Error 2.4012
|
4.100 Score on a scale
Standard Error 1.0433
|
SECONDARY outcome
Timeframe: Day 0 to Week 8Population: The Blinded Phase Safety population included all participants who received any active tcVNS stimulation or sham stimulation from Day 0 through the day before the Week 8 visit.
A participant who experienced any of the following untoward or unfavorable medical occurrence(s) associated with the investigational device or any study mandated procedures following the first stimulation on Day 0 and prior to the Week 8 visit: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Number of Participants With a Treatment-emergent Adverse Event From Day 0 to Week 8.
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 16Population: The Open-Label Phase Safety population included all participants who received any active tcVNS stimulation on or after the Week 8 visit.
A participant who experienced any of the following untoward or unfavorable medical occurrence(s) associated with the investigational device or any study mandated procedures between Week 8 and Week 16: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
Outcome measures
| Measure |
Sham Stimulation
n=8 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=7 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Number of Participants With a Treatment-emergent Adverse Event From Week 8 to Week 16
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Week 8Population: The Blinded Phase Safety population included all participants who received any active tcVNS stimulation or sham stimulation from Day 0 to the day before the Week 8 visit.
A participant who experienced any serious untoward or unfavorable medical occurrence(s) associated with the investigational device or any study mandated procedures following the first stimulation on Day 0 and prior to the Week 8 visit.
Outcome measures
| Measure |
Sham Stimulation
n=9 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=8 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Number of Participants With a Treatment-emergent Serious Adverse Event From Day 0 to Week 8
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 16Population: The Open-Label Phase Safety population included all participants who received any active tcVNS stimulation on or after the Week 8 visit.
A participant who experienced any serious untoward or unfavorable medical occurrence(s) associated with the investigational device or any study mandated procedures between Week 8 and Week 16.
Outcome measures
| Measure |
Sham Stimulation
n=8 Participants
Participants in the Sham Stimulation arm stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit and then stimulated for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16.
|
Active tcVNS
n=7 Participants
Participants in the Active tcVNS arm stimulated themselves for 5 minutes daily with the investigation device at the cymba concha through Week 16.
|
|---|---|---|
|
Number of Participants With a Treatment-emergent Serious Adverse Event From Week 8 to Week 16
|
0 Participants
|
0 Participants
|
Adverse Events
Blinded Phase: Active tcVNS
Blinded Phase: Sham Stimulation
Open-Label Phase: Active tcVNS Following Active tcVNS
Open-Label Phase: Active tcVNS Following Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blinded Phase: Active tcVNS
n=8 participants at risk
Participants stimulated themselves for 5 minutes daily with active tcVNS at the cymba concha using the investigational device through the day prior to the Week 8 visit.
|
Blinded Phase: Sham Stimulation
n=9 participants at risk
Participants stimulated themselves for 5 minutes daily with sham stimulation at the neck through the day prior to the Week 8 visit.
|
Open-Label Phase: Active tcVNS Following Active tcVNS
n=7 participants at risk
Participants stimulated themselves for 5 minutes daily with active tcVNS using the investigational device at the cymba concha from Week 8 through Week 16, following active tcVNS in the 8-week blinded period. Participants are only included in the Open-Label Phase if they stimulated at least once on or after the Week 8 visit.
|
Open-Label Phase: Active tcVNS Following Sham Stimulation
n=8 participants at risk
Participants stimulated themselves for 5 minutes daily with active tcVNS at the cymba concha using the investigational device from Week 8 through Week 16, following sham stimulation in the 8-week blinded period. Participants are only included in the Open-Label Phase if they stimulated at least once on or after the Week 8 visit.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/7 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
General disorders
Medical device site irritation
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/7 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/7 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/7 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/8 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/9 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
0.00%
0/7 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after initiation of stimulation at Day 0 to Week 16.
The following AEs were recorded in EDC: * Grade 1 or higher mild palpitations, documented arrhythmia, or any unpleasant sensations caused by palpitations * Grade 1 or higher stimulation site reactions such as cutaneous irritation, pain, or skin burns * Grade 1 or higher Ear and labyrinth disorders as listed in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except those of the middle ear * Grade 1 or higher JIA flares * All other Grade 2 and higher AEs
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place