Wpływ przezskórnej stymulacji pola elektrycznego nerwów na kontrolę objawów/aktywność układu nerwowego u pacjentów z cukrzycą typu 1 lub 2 (PENFS)
Wpływ przezskórnej stymulacji pola elektrycznego nerwów (PENFS) na kontrolę objawów i aktywność autonomicznego układu nerwowego u pacjentów z cukrzycą
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
Przegląd badań
Status
Warunki
Szczegółowy opis
The vagus nerve is one of the main determinants of gastrointestinal motility and gastric emptying. It has been speculated that neuropathy of the vagus nerve is the cause of the delay in gastric emptying in gastroparesis, the symptoms of which include nausea, vomiting, weight loss, early satiety, abdominal pain and bloating.
Percutaneous Electrical Nerve Field Stimulation (PENFS) has been approved by the FDA to treat adolescents with functional abdominal pain associated with irritable bowel syndrome. In this study, the impact of PENFS on gastroparesis symptoms will be evaluated.
After informed consent is obtained, participant eligibility will be assessed at a Screening Visit. A Hemoglobin A1C level (HgbA1c) will be drawn for this purpose. Eligible participants will then return for 5 Study Visits at which, they will:
- Complete will complete 4 questionnaires
- Lie in a supine position and have ECG electrodes applied to the chest and/or arms, palmar skin electrodes placed on the fingers of the non-dominant hand to measure galvanic skin response (GSR) and sympathetic nerve activity, and a chest strap to record respiratory activity. Once the equipment is placed, electrocardiogram (ECG) and GSR will be recorded for 20 minutes in the supine position. After the 20 minutes, participants will be asked to sit while ECG and GSR are recorded for 2 additional minutes. Participants will then stand for an additional 2 minutes of ECG and GSR recordings.
- Have a PENFS device applied to the left ear (the device will be applied at the first four study visits, and not at the fifth). The device will remain in place for 5 days after each visit.
Each participant will have a PENFS device applied at the study visits, however, participants are randomized to whether they will receive active stimulation during the study. The device will remain in place for 5 days after each visit. On the morning of Day 6 after each study visit, the participants will remove the PENFS device and return it at the next study visit.
Participants will also complete a daily diary to document symptoms over the previous 24 hours. Prior to each study visit, participants will be asked to refrain from caffeine on the day of the visit and to refrain from nicotine use for 24 hours prior to the visit.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Maureen Schilling, BS
- Numer telefonu: 317-278-2064
- E-mail: maschi@iu.edu
Lokalizacje studiów
-
-
Indiana
-
Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University Hospital
-
Główny śledczy:
- Thomas V Nowak, MD
-
Kontakt:
- Maureen Schilling, BS
- Numer telefonu: 3172782064
- E-mail: maschi@iu.edu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Wiling to have one teaspoon (5 ml) of blood drawn.
- Willing to have electrodes placed in the external ear.
- Diagnosed with gastroparesis for twelve months or longer
- Diagnosed with diabetes either Type 1 or Type 2
- Documented delayed gastric emptying (>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.
- Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.
- Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.
- Documented Hb A1c within three months of screening or at the time of screening (<=8.0)
Exclusion Criteria:
- Unable to provide consent
- Pregnant females
- Medical records indicate intestinal pseudo-obstruction
- Diagnosed with cardiac arrhythmia
- History of prior gastric surgery
- History of vagotomy
- History of organ transplantation
- History of seizures
- Diagnosed with primary swallowing disorders
- Subjects who are dependent on drugs like Marinol for their condition
- Those diagnosed with psychogenic vomiting and not related to gastroparesis
- Medically unstable subjects
- Those at high surgical risk
- Subjects taking narcotic analgesics daily.
- Those with poorly controlled diabetes mellitus (Hgb A1c>8) within three months of screening or at the time of screening.
- Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded
- Those having a cardiac pacemaker will be excluded from the study.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: ACTIVE (electrical charge)
The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses throughout the auricle. |
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
Inne nazwy:
|
|
Pozorny komparator: Sham percutaneous electrical nerve field stimulation (no electrical charge)
The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance will not transmit any electrical impulses. |
SHAM (no electrical charge) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
Ramy czasowe: Baseline, Week 5
|
A modified version of the GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY (GCSI-DD) will be used. The questionnaire evaluates 4 gastroparesis symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) and asks participants to rate the severity of symptoms over the past 24 hours on a scale from 0 (none) to 4 (very severe). Additionally, vomiting episodes are reported (0 for none, 1 for one episode, 2 for two episodes, 3 for three episodes, or 4 for four or more episodes). Lower total scores indicate fewer or less severe symptoms. |
Baseline, Week 5
|
|
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
Ramy czasowe: Baseline, Week 5
|
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms. |
Baseline, Week 5
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Heart Rate Variability
Ramy czasowe: Baseline, Week 5
|
Heart Rate Variability is reported on a 0-100 scale. |
Baseline, Week 5
|
|
Change in Anxiety
Ramy czasowe: Baseline, Week 5
|
The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety |
Baseline, Week 5
|
|
Change in the measure of depression
Ramy czasowe: Baseline, Week 5
|
Patient Health Questionnaire (PHQ)-8 is a questionnaire that measures self-reported depressive systems. PHQ-8 uses a range from 0-24, where 0=no depressive symptoms and 24=severe symptoms. |
Baseline, Week 5
|
|
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms by Diabetes Type
Ramy czasowe: Baseline, Week 5
|
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms. |
Baseline, Week 5
|
|
Change in Gastroparesis Cardinal Symptom Index Daily Diary by Diabetes Type
Ramy czasowe: Baseline, Week 5
|
A modified version of the GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY (GCSI-DD) will be used. The questionnaire evaluates 4 gastroparesis symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) and asks participants to rate the severity of symptoms over the past 24 hours on a scale from 0 (none) to 4 (very severe). Additionally, vomiting episodes are reported (0 for none, 1 for one episode, 2 for two episodes, 3 for three episodes, or 4 for four or more episodes). Lower total scores indicate fewer or less severe symptoms. |
Baseline, Week 5
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Thomas V Nowak, MD, IU School of Medicine/IU Health
Publikacje i pomocne linki
Publikacje ogólne
- Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.
- 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.
- Berntson GG, Bigger JT Jr, Eckberg DL, Grossman P, Kaufmann PG, Malik M, Nagaraja HN, Porges SW, Saul JP, Stone PH, van der Molen MW. Heart rate variability: origins, methods, and interpretive caveats. Psychophysiology. 1997 Nov;34(6):623-48. doi: 10.1111/j.1469-8986.1997.tb02140.x.
- Lewis GF, Furman SA, McCool MF, Porges SW. Statistical strategies to quantify respiratory sinus arrhythmia: are commonly used metrics equivalent? Biol Psychol. 2012 Feb;89(2):349-64. doi: 10.1016/j.biopsycho.2011.11.009. Epub 2011 Dec 3.
- Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
- Revicki DA, Speck RM, Lavoie S, Puelles J, Kuo B, Camilleri M, Almansa C, Parkman HP. The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD): Psychometric evaluation in patients with idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2019 Apr;31(4):e13553. doi: 10.1111/nmo.13553. Epub 2019 Feb 7.
- Kovacic K, Kolacz J, Lewis GF, Porges SW. Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders. Am J Gastroenterol. 2020 Sep;115(9):1534-1538. doi: 10.14309/ajg.0000000000000753.
- Porges SW. Method and apparatus for evaluating rhythmic oscillations in aperiodic physiological response systems. US4510944A, 1985 cited 2020 Aug 4.
- Asahina M, Poudel A, Hirano S. Sweating on the palm and sole: physiological and clinical relevance. Clin Auton Res. 2015 Jun;25(3):153-9. doi: 10.1007/s10286-015-0282-1. Epub 2015 Apr 17.
- 11. Dawson ME, Schell AM, Filion DL. The electrodermal system. In: Handbook of Physiology. 3rd ed. New York: Cambridge University Press; 2007. p. 159-81.
- Woodbury A, Krishnamurthy V, Gebre M, Napadow V, Bicknese C, Liu M, Lukemire J, Kalangara J, Cui X, Guo Y, Sniecinski R, Crosson B. Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Pain Med. 2021 Mar 18;22(3):715-726. doi: 10.1093/pm/pnaa317.
- Santucci NR, King C, El-Chammas KI, Wongteerasut A, Damrongmanee A, Graham K, Fei L, Sahay R, Jones C, Cunningham NR, Coghill RC. Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders. Neurogastroenterol Motil. 2022 Aug;34(8):e14358. doi: 10.1111/nmo.14358. Epub 2022 Mar 16.
- Ward MP, Gupta A, Wo JM, Rajwa B, Furness JB, Powley TL, Nowak TV. An emerging method to noninvasively measure and identify vagal response markers to enable bioelectronic control of gastroparesis symptoms with gastric electrical stimulation. J Neurosci Methods. 2020 Apr 15;336:108631. doi: 10.1016/j.jneumeth.2020.108631. Epub 2020 Feb 20.
- Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472. doi: 10.1097/j.pain.0000000000000930.
- Abell T, McCallum R, Hocking M, Koch K, Abrahamsson H, Leblanc I, Lindberg G, Konturek J, Nowak T, Quigley EM, Tougas G, Starkebaum W. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003 Aug;125(2):421-8. doi: 10.1016/s0016-5085(03)00878-3.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 18260
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
All data and devices will be stored containing only the study subject number and dates of device usage. Sharing this data will not involve any IPD.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .