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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK116969-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea. A neurostimulator is applied to the outer ear and stimulates several nerves that are thought to be involved in transmission of nausea and vomiting signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.
By stimulating branches of several cranial nerves in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional nausea.
The study has the following specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Neurostimulation | Experimental | Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks |
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| Sham Auricular Neurostimulation | Sham Comparator | Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Auricular Neurostimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Severity Scale | 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. | After 4 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Profile | Measures 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. | After 4 weeks of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Kovacic, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28526575 | Background | Babygirija R, Sood M, Kannampalli P, Sengupta JN, Miranda A. Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats. Neuroscience. 2017 Jul 25;356:11-21. doi: 10.1016/j.neuroscience.2017.05.012. Epub 2017 May 17. | |
| 27843360 | Background | Roberts A, Sithole A, Sedghi M, Walker CA, Quinn TM. Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Med Devices (Auckl). 2016 Nov 3;9:389-393. doi: 10.2147/MDER.S107426. eCollection 2016. |
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n=1 participant excluded after enrollment but prior to randomization due to ineligibility (alternate diagnosis discovered)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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4 participants excluded from analyses (n=1 treatment and n=3 sham) due to baseline scores of zero on primary outcome (n=3) and alternate diagnosis discovered (n=1)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nausea Severity Scale | 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. | Posted | Median | Inter-Quartile Range | units on a scale | After 4 weeks of therapy |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild skin irritation from adhesive |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Medical College of Wisconsin | 4142666131 | ksiegel@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | May 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Randomized, double blind placebo-controlled trial
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All participants, investigators and study team members blinded
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| Sham Auricular Neurostimulation | Device | 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. |
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| Baxter Retching Faces Scale | 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. | Average score during week 4 of therapy |
| 28826627 | Result | Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Nausea Severity Scale | Nausea Severity Scale 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. | Median | Inter-Quartile Range | units on a scale |
|
| Nausea Profile | Nausea Profile measures 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. | Median | Inter-Quartile Range | units on a scale |
|
| Baxter Retching faces scale | Baxter Retching faces scale 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. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 |
| 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. |
|
|
| Secondary | Nausea Profile | Measures 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. | Posted | Median | Inter-Quartile Range | units on a scale | After 4 weeks of therapy |
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|
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| Secondary | Baxter Retching Faces Scale | 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. | Some missing data as not all participants completed the daily diaries | Posted | Median | Inter-Quartile Range | units on a scale | Average score during week 4 of therapy |
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|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 11 |
| 50 |
| EG001 | 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. | 0 | 46 | 0 | 46 | 16 | 46 |
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| Local discomfort | General disorders | Systematic Assessment | Local discomfort at site of electrode placement |
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| Headache | Nervous system disorders | Systematic Assessment | Mild headache, possible related to intervention. Resolved. |
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| Dizziness | Nervous system disorders | Systematic Assessment | mild, possibly related to intervention |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | Moderate; possibly related to intervention |
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