Trial Outcomes & Findings for Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response (NCT NCT03675321)
NCT ID: NCT03675321
Last Updated: 2025-11-20
Results Overview
Measures 1) frequency of nausea on a scale 0-4 over past week (0=not at all; 4=every day), 2) average number of nausea episodes/day over past week on a scale 0-4 (0=none; 4=constant), 3) average duration of nausea episodes over past week on scale 0-4 (0=none; 4=most or all of day) and 4) severity of nausea on scale 0-10 (0=none;10=most nausea possible). The severity subscale is converted to a 5 point scale ranging from 0-4. The mean of all 4 subscales yields a total score ranging from 0 to 4, with a higher score indicating more severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
After 4 weeks of therapy
Results posted on
2025-11-20
Participant Flow
n=1 participant excluded after enrollment but prior to randomization due to ineligibility (alternate diagnosis discovered)
Participant milestones
| Measure |
Auricular Neurostimulation
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
Sham Auricular Neurostimulation
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Auricular Neurostimulation
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
Sham Auricular Neurostimulation
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
Baseline characteristics by cohort
| Measure |
Auricular Neurostimulation
n=50 Participants
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
Sham Auricular Neurostimulation
n=46 Participants
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
|
46 Participants
n=4 Participants
|
94 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
15.04 years
|
15.79 years
n=4 Participants
|
15.13 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
|
38 Participants
n=4 Participants
|
77 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
|
45 Participants
n=4 Participants
|
93 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
50 participants
|
46 participants
n=4 Participants
|
96 participants
n=8 Participants
|
|
Nausea Severity Scale
|
2.85 units on a scale
|
2.75 units on a scale
n=4 Participants
|
2.78 units on a scale
n=8 Participants
|
|
Nausea Profile
|
44.44 units on a scale
|
49.67 units on a scale
n=4 Participants
|
47.08 units on a scale
n=8 Participants
|
|
Baxter Retching faces scale
|
2.83 units on a scale
|
3.14 units on a scale
n=4 Participants
|
2.99 units on a scale
n=8 Participants
|
PRIMARY outcome
Timeframe: After 4 weeks of therapyMeasures 1) frequency of nausea on a scale 0-4 over past week (0=not at all; 4=every day), 2) average number of nausea episodes/day over past week on a scale 0-4 (0=none; 4=constant), 3) average duration of nausea episodes over past week on scale 0-4 (0=none; 4=most or all of day) and 4) severity of nausea on scale 0-10 (0=none;10=most nausea possible). The severity subscale is converted to a 5 point scale ranging from 0-4. The mean of all 4 subscales yields a total score ranging from 0 to 4, with a higher score indicating more severity.
Outcome measures
| Measure |
Auricular Neurostimulation
n=50 Participants
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
|
Sham Auricular Neurostimulation
n=46 Participants
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
|
|---|---|---|
|
Nausea Severity Scale
|
2.18 units on a scale
Interval 1.55 to 3.3
|
2.45 units on a scale
Interval 1.6 to 3.1
|
SECONDARY outcome
Timeframe: After 4 weeks of therapyMeasures 3 dimensions of nausea (Emotional, GI and Somatic distress) with 17 items. Each sub scale is measured on a 10-point scale from 0-9 (0=not at all; 9=severely). Total score is calculated as follows: actual score/153 \* 100%. Subscales are similarly computed into a percentage score. Higher percentage indicates worse outcomes.
Outcome measures
| Measure |
Auricular Neurostimulation
n=50 Participants
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
|
Sham Auricular Neurostimulation
n=46 Participants
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
|
|---|---|---|
|
Nausea Profile
|
33.33 units on a scale
Interval 15.69 to 49.02
|
28.43 units on a scale
Interval 16.34 to 51.63
|
SECONDARY outcome
Timeframe: Average score during week 4 of therapyPopulation: Some missing data as not all participants completed the daily diaries
Measures daily nausea severity on a pictorial faces scale from 0-10 (0=no nausea; 10=most nausea possible). Weekly averages will be computed and change from baseline to average severity during last week of therapy will be assessed. Higher values indicate worse outcome.
Outcome measures
| Measure |
Auricular Neurostimulation
n=37 Participants
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
|
Sham Auricular Neurostimulation
n=33 Participants
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
|
|---|---|---|
|
Baxter Retching Faces Scale
|
2.29 units on a scale
Interval 1.14 to 4.0
|
3.43 units on a scale
Interval 1.67 to 4.86
|
Adverse Events
Sham Auricular Neurostimulation
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Auricular Neurostimulation
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Auricular Neurostimulation
n=46 participants at risk
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
Sham Auricular Neurostimulation: Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
|
Auricular Neurostimulation
n=50 participants at risk
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Active Auricular Neurostimulation: Active auricular neurostimulation for 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
0.00%
0/50 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
23.9%
11/46 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
10.0%
5/50 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
|
General disorders
Local discomfort
|
8.7%
4/46 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
8.0%
4/50 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/46 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
2.0%
1/50 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
2.0%
1/50 • Weekly assessment during intervention and at follow-up visits after end of study for a total of 6 months.
Adverse events assessed by research nurse and research coordinator weekly during treatment intervention and at all follow up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place