Trial Outcomes & Findings for A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders (NCT NCT04247100)
NCT ID: NCT04247100
Last Updated: 2023-10-12
Results Overview
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
Active Stimulation (8)
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
Baseline characteristics by cohort
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=5 Participants
|
15.3 years
n=7 Participants
|
15.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Heart Rate Variability at 4 Weeks
Standing
|
-639 milliseconds (ms)^2
Standard Deviation 988
|
-264 milliseconds (ms)^2
Standard Deviation 244
|
|
Change in Heart Rate Variability at 4 Weeks
Supine
|
5360 milliseconds (ms)^2
Standard Deviation 11500
|
-5440 milliseconds (ms)^2
Standard Deviation 9340
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Heart Rate Variability at 8 Weeks
Standing
|
-678 milliseconds (ms)^2
Standard Deviation 1520
|
-65.9 milliseconds (ms)^2
Standard Deviation 613
|
|
Change in Heart Rate Variability at 8 Weeks
Supine
|
1640 milliseconds (ms)^2
Standard Deviation 3750
|
-8550 milliseconds (ms)^2
Standard Deviation 11200
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)
|
19.5 pmol/min/μg of protein
Standard Deviation 27
|
6.47 pmol/min/μg of protein
Standard Deviation 26.5
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=1 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)
|
35.3 pmol/min/μg of protein
Standard Deviation 7.6
|
31 pmol/min/μg of protein
Standard Deviation NA
There were 4 subjects in the Sham group. All 4 had Week 0 Basal measures, but only 1 had Week 8 Basal measures. Therefore, there is only 1 subject with difference between Week 0 and Week 8 calculated, and thus there is no SD based on only 1 difference.
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation.
Outcome measures
| Measure |
Active Stimulation (8)
n=3 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=3 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks
|
-0.237 pg/mL
Standard Deviation 0.888
|
-2.15 pg/mL
Standard Deviation 3.80
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation
Outcome measures
| Measure |
Active Stimulation (8)
n=3 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=1 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks
|
-0.600 pg/mL
Standard Deviation 3.17
|
-1.35 pg/mL
Standard Deviation NA
Only 1 participant in this group had Week 8 measures. Therefore, there is only 1 subject with difference between Week 0 and Week 8 calculated, and thus there is no SD based on only 1 difference.
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.The Functional Disability Inventory (FDI) Child and Adolescent questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4 for each item (0-No trouble, 1- A Little Trouble, 2- Some Trouble, 3- A Lot of Trouble, 4- Impossible). Higher total scores indicate more difficulty functioning due to physical health, based on a sum score of each item. Sum score interpretation cutoffs include: No/Minimal Disability (0-12), Mild Disability (13-20), Moderate Disability (21-29) and Severe Disability (≥30).
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Functional Disability Inventory (Child and Adolescent)
Change from baseline to 4 weeks
|
-3.5 Score on a scale
Standard Deviation 10.2
|
0.75 Score on a scale
Standard Deviation 0.957
|
|
Change From Baseline in Functional Disability Inventory (Child and Adolescent)
Change from baseline to 8 weeks
|
-2.50 Score on a scale
Standard Deviation 9.95
|
1.00 Score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.Population: Only one participant reported a Symptom 5 Intensity at Week 4, as well as Symptoms 3, 4, and 5 Intensity at Week 8, therefore no Standard Deviation could be calculated for these results.
Symptom Intensity Questionnaire score will be used to identify the most prominent 5 complaints, with intensity rated on a 10-point centimeter Likert scale. Participants write up to 5 of their most severe symptoms, and then rate those symptoms' severity from none (0) to worst you can possibly imagine (10) by placing a vertical line on the scale. Higher symptom ratings reflect higher symptom intensity \& frequency. A 1-3 frequency level is a minimum level and indicates symptoms are occasional. A 4-6 frequency is a moderate level, meaning that symptoms are intermittent, coming and going. A 7-8 frequency is an indication that the symptoms are present more often than not but still not constant. A 9-10 frequency level is severe and indicates that symptoms are constant. The electronic data capture system's field validation used during the study automatically translated the participant-facing 0-10 slider scale placement into a score of 0-100, hence the reported mean values of over 10.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 1- Change from baseline to week 4
|
26 Centimeters on a slider scale
Standard Deviation 29.7
|
6.75 Centimeters on a slider scale
Standard Deviation 19.2
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 2- Change from baseline to week 4
|
21 Centimeters on a slider scale
Standard Deviation 27.4
|
4.25 Centimeters on a slider scale
Standard Deviation 37.1
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 3- Change from baseline to week 4
|
-2.67 Centimeters on a slider scale
Standard Deviation 12.1
|
26.7 Centimeters on a slider scale
Standard Deviation 33.3
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 4- Change from baseline to week 4
|
-5 Centimeters on a slider scale
Standard Deviation 14.1
|
-9.5 Centimeters on a slider scale
Standard Deviation 0.707
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 5- Change from baseline to week 4
|
20 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 5 intensity at both baseline \& week 4.
|
-10 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 5 intensity at both baseline \& week 4.
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 1- Change from baseline to week 8
|
78.7 Centimeters on a slider scale
Standard Deviation 11
|
41.5 Centimeters on a slider scale
Standard Deviation 33.1
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 2- Change from baseline to week 8
|
60.5 Centimeters on a slider scale
Standard Deviation 38.9
|
15.3 Centimeters on a slider scale
Standard Deviation 18.6
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 3- Change from baseline to week 8
|
30 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 3 intensity at both baseline \& week 8.
|
15 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 3 intensity at both baseline \& week 8.
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 4- Change from baseline to week 8
|
65 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 4 intensity at both baseline \& week 8.
|
40 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 4 intensity at both baseline \& week 8.
|
|
Change From Baseline in Symptom Intensity Questionnaire
Symptom 5- Change from baseline to week 8
|
72 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 5 intensity at both baseline \& week 8.
|
70 Centimeters on a slider scale
Standard Deviation NA
Only one participant reported symptom 5 intensity at both baseline \& week 8.
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.The Pain Catastrophizing Scale Child form (PCS-C) will be completed by the participant. The PCS-C is a modification of the adult Pain Catastrophizing Scale for use in children, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Pain Catastrophizing Scale (Child)
|
2.5 Score on a scale
Standard Deviation 9.11
|
-0.0667 Score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Changes in generalized anxiety & depression t-scores (translated from raw subscale scores) in baseline to week 4 and baseline to week 8 are reported.The Revised Child Anxiety and Depression Scale (RCADS) assesses children grades 3 to 12 containing subscales assessing for symptoms of anxiety and depression. Participants rate frequency of occurrences described in the items on a 4 point scale (0- Never, 1- Sometimes, 2- Often, or 3- Always). Sum scores of anxiety/depression items were assessed. Depression items: score range 0-30 Anxiety items: score range 0-18 Higher scores on both the depression \& anxiety items indicate higher levels of depression \& anxiety. Raw sum scores of both the depression \& anxiety subscale items are translated to a T-score. T-scores below 65 represent low severity. T-scores between 65-70 represent medium severity and are on the borderline clinical threshold. T-scores above 70 represent high severity and are above the clinical threshold. A T-score of 50 indicates the population mean with a standard deviation of 10.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Revised Child Anxiety and Depression Scale
Change from Baseline to 8 weeks- Major Depression Subscale
|
0.75 T-score
Standard Deviation 0.957
|
-2.00 T-score
Standard Deviation 3.00
|
|
Change From Baseline in Revised Child Anxiety and Depression Scale
Change from Baseline to 8 weeks- Generalized Anxiety Subscale
|
1.00 T-score
Standard Deviation 1.83
|
0.333 T-score
Standard Deviation 0.577
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.The Functional Disability Inventory (FDI) Parent questionnaire will be used to assess change in the participants symptoms as rated by the participants parent/guardian. Parents will rank their child's physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4 for each item (0-No trouble, 1- A Little Trouble, 2- Some Trouble, 3- A Lot of Trouble, 4- Impossible). Higher total scores indicate more difficulty functioning due to physical health, based on a sum score of each item. Sum score interpretation cutoffs include: No/Minimal Disability (0-12), Mild Disability (13-20), Moderate Disability (21-29) and Severe Disability (≥30).
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Functional Disability Inventory (Parent)
Change from baseline to week 4
|
-6.25 Score on a scale
Standard Deviation 5.12
|
-2.5 Score on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Functional Disability Inventory (Parent)
Change from baseline to week 8
|
-3.67 Score on a scale
Standard Deviation 9.29
|
-8 Score on a scale
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported.The Pain Catastrophizing Scale Parent form (PCS-P) will be completed by the parent or guardian of the participant. The PCS-P is a proxy questionnaire to the PCS-C, measuring the feelings the parent has when their child is in pain. Parents rate how strongly they feel when their child is in pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.
Outcome measures
| Measure |
Active Stimulation (8)
n=4 Participants
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Sham Stimulation (4), Active (4)
n=4 Participants
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
|
|---|---|---|
|
Change From Baseline in Pain Catastrophizing Scale (Parent)
|
-5.67 Score on a scale
Standard Deviation 7.51
|
-3.0 Score on a scale
Standard Deviation 9.42
|
Adverse Events
Active Stimulation (8)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Stimulation for 4 Weeks (Following Sham Stimulation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation for 4 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Stimulation (8)
n=5 participants at risk
Participants will receive active auricular microstimulation via TENS unit for 8 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
|
Active Stimulation for 4 Weeks (Following Sham Stimulation)
n=5 participants at risk
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered.
Participants in this group received both sham and active stimulation.
|
Sham Stimulation for 4 Weeks
n=5 participants at risk
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks.
Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).
Transcutaneous Electrical Nerve Stimulation (TENS): Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve Stimulation: Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered.
Participants in this group received both sham and active stimulation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Symptoms
|
20.0%
1/5 • Number of events 1 • Through study completion, an average of 2 months.
Participants contacted the study team to report adverse events.
|
0.00%
0/5 • Through study completion, an average of 2 months.
Participants contacted the study team to report adverse events.
|
0.00%
0/5 • Through study completion, an average of 2 months.
Participants contacted the study team to report adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place