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Funding ended prior to hitting the enrollment goal
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The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation (8) | Experimental | 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. |
|
| Sham Stimulation (4), Active (4) | Sham Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | Active Transcutaneous Auricular Microstimulation delivered by TENS device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability at 4 Weeks | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
| Change in Heart Rate Variability at 8 Weeks | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported. |
| Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption) | 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. | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
| Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption) | 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. | Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported. |
| Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks | Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation. | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
| Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Functional Disability Inventory (Child and Adolescent) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisela Chelimsky, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28826627 | Background | 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. | |
| 27957782 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 17, 2022 |
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30 participants will be enrolled in this double-blind sham control study. Fifteen participants will undergo sham stimulation for 4 weeks followed by active microstimulation for 4 weeks. The other 15 participants will have active microstimulation for all 8 weeks.
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Participants will be sent home at baseline with a TENS unit and a sealed envelope with instructions for device settings. The envelope will contain instructions for either sham stimulation or active stimulation (unknown to the performing coordinator and participant). Both groups will receive a new device and another set of instructions from the study team at 4 weeks. It is possible and permitted that the performing study coordinator will become aware of which group the subject is in when checking in on the subject.
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| Sham Transcutaneous Electrical Nerve Stimulation | Device | Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered |
|
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Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation |
| Assessed at baseline, week 4, and week 8. Change in baseline to week 8. |
| Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported. |
| Change From Baseline in Symptom Intensity Questionnaire | 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. | Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported. |
| Change From Baseline in Pain Catastrophizing Scale (Child) | 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. | Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported. |
| Change From Baseline in Revised Child Anxiety and Depression Scale | 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. | 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. |
| Change From Baseline in Functional Disability Inventory (Parent) | 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). | Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported. |
| Change From Baseline in Pain Catastrophizing Scale (Parent) | 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. | Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported. |
| Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12. |
| 24948120 | Background | Ji RR, Xu ZZ, Gao YJ. Emerging targets in neuroinflammation-driven chronic pain. Nat Rev Drug Discov. 2014 Jul;13(7):533-48. doi: 10.1038/nrd4334. Epub 2014 Jun 20. |
| FG001 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Change in Heart Rate Variability at 4 Weeks | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | Posted | Mean | Standard Deviation | milliseconds (ms)^2 | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
|
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| Primary | Change in Heart Rate Variability at 8 Weeks | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | Posted | Mean | Standard Deviation | milliseconds (ms)^2 | Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption) | 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. | Posted | Mean | Standard Deviation | pmol/min/μg of protein | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption) | 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. | Posted | Mean | Standard Deviation | pmol/min/μg of protein | Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks | Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation. | Posted | Mean | Standard Deviation | pg/mL | Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks | Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation | Posted | Mean | Standard Deviation | pg/mL | Assessed at baseline, week 4, and week 8. Change in baseline to week 8. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Disability Inventory (Child and Adolescent) | 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). | Posted | Mean | Standard Deviation | Score on a scale | Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported. |
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| Secondary | Change From Baseline in Symptom Intensity Questionnaire | 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. | 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. | Posted | Mean | Standard Deviation | Centimeters on a slider scale | Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported. |
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| Secondary | Change From Baseline in Pain Catastrophizing Scale (Child) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported. |
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| Secondary | Change From Baseline in Revised Child Anxiety and Depression Scale | 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. | Posted | Mean | Standard Deviation | T-score | 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. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Disability Inventory (Parent) | 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). | Posted | Mean | Standard Deviation | Score on a scale | Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported. |
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| Secondary | Change From Baseline in Pain Catastrophizing Scale (Parent) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported. |
|
Through study completion, an average of 2 months.
Participants contacted the study team to report adverse events.
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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 | 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 | 0 | 5 | 0 | 5 | 1 | 5 |
| EG001 | Active Stimulation for 4 Weeks (Following Sham Stimulation) | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Sham Stimulation for 4 Weeks | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Symptoms | Gastrointestinal disorders | Non-systematic Assessment | Subject used TENS device for the first time 4/8/21 and woke up 4/9/21 with nausea, stomach pain, diarrhea and hiccups. Symptoms did not improve after 5 days, so subject was withdrawn at PI discretion and referred for GI follow-up. Unrelated to TENS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gisela Chelimsky, MD | Virginia Commonwealth University | 804-628-4859 | gisela.chelimsky@vcuhealth.org |
| Dec 9, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D043183 | Irritable Bowel Syndrome |
| D009325 | Nausea |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| OG001 | 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 |
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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 |
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