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A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear

2. März 2022 aktualisiert von: DyAnsys, Inc.

Auricular Percutaneous Electrical Neural Field Stimulation in Short-Term Treatment of Alcohol Dependence- Neurohaemodynamic Correlates and Feasibility Study

Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse. Keeping in mind the high burden of disease due to AUD, limited efficacy of available treatment modalities it is important to study new treatment modalities. Vagus nerve stimulation (VNS) is a promising neuromodulation technique with robust evidence in epilepsy and treatment-resistant depression. fMRI studies show that transcutaneous VNS (tVNS) replicates most of the biological effects of VNS with an additional advantage of being non-invasive. Percutaneous Electrical Neural Field Stimulation (PENFS) of auricular branch of vagus nerve is a variant of tVNS which has shown promise in the treatment of opioid withdrawal. The efficacy of PENFS has been evaluated in AUDs in only handful of studies.

I propose to employ a double-blind randomized sham-controlled trial where 40 subjects with AUD will be randomized to 2 groups, with 1 group receiving 'Active' auricular PENFS, and another group receiving bilateral 'sham' auricular PENFS.

Assessments will be carried out at baseline and after 15 days of advent of PENFS on tasks to assess craving, along with neurohemodynamic changes on functional Magnetic Resonance Image (fMRI). Follow up of patients will be done till the first relapse or till 3 months after the post evaluation, whichever is earlier.

The investigator's hypotheses are:

  1. Active PENFS will lead to significantly greater improvement in subjective craving and drinking-related outcomes as compared to sham PENFS in patients with AUD over the follow-up period of 3 months.
  2. Active PENFS will produce a significantly differential Blood Oxygen Level Dependent (BOLD) activation-deactivation pattern of brain regions (greater activation of dorsolateral prefrontal cortex and anterior cingulate cortex and along with deactivation of insular cortex) associated with craving during a cue-induction paradigm as compared to sham PENFS in patients with AUD.
  3. Active PENFS will result in a significant differential change in resting-state functional connectivity (fMRI measured) within and between addiction-related neural networks as compared to sham PENFS as evaluated with a resting state fMRI analysis in patients with AUD.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Patients will be recruited into the study after obtaining informed consent. The intervention will be started after completion of detoxification, which will be done with Lorazepam using a front-loading regimen and a drug washout period of 5 half-lives (approx. 3 days) will be given so as not to interfere with the stimulation. Amitriptyline 12.5-25mg will be used as rescue medication for sleep difficulty. All subjects will receive psychosocial interventions related to craving management and relapse prevention as per treatment as usual but will not be prescribed any anti-craving agents during the period of the study.The Drug Relief V 2.0 device will be installed after the detoxification and baseline fMRI scan. After installation, it will automatically provide neurostimulation at regular interval. It will be in situ for the next 15 days. After that, it will be removed temporarily for follow-up fMRI scanning.After completion of scanning a new device will be provided. The current research study will follow standard auricular PENFS procedures with established safety. The battery of the device will last for 15 days. Study subjects will be required to visit NIMHANS (National Institute of mental health and neurosciences) every 15 days to replace the old device for a new one. Till 3 months, all the devices will be provided free of costPatients will be followed up as usual on an outpatient basis, and the recent pattern of alcohol use will be inquired into. The follow-up will be done until the patient has a relapse or a maximum period of three months, whichever is earlier.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

44

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Indien
    • Karnataka
      • Bengaluru, Karnataka, Indien, 560029
        • National Institute of Mental Health and Neuro sciences(NIMHANS)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Inclusion Criteria:

  1. Diagnosis of Alcohol use disorder (AUD) as per DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two psychiatrists working in the department of psychiatry NIMHANS.
  2. Male gender.
  3. Age not less than 18 years and not more than 50 years.
  4. At least, moderately severe AUD as ascertained by a score above 16 in Severity of Alcohol dependence questionnaire (SADQ).
  5. Right-handedness as assessed with Edinburgh Handedness Inventory.
  6. Informed consent and willingness to come for regular follow-ups (once every two weeks) for three months after recruitment in the study.

Exclusion Criteria:

  1. Any diagnosis except alcohol dependence syndrome/ Tobacco dependence syndrome (to apply MINI(Mini International Neuropsychiatric Interview) screen).

  2. Contra-indications precluding device use-

    2.1 patient with cardiac implants or similar biomedical implants, 2.2 during pregnancy unless medically advised, 2.3 patient with haemophilia 2.4 skin pathology 2.5 patient with diminished mental capability or physical competence about the handling of the device

  3. Left/ mixed handedness
  4. Contraindications to MRI

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Active Arm
Active arm: Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) device will stimulate the outer auditory canal. It will deliver with a pulse width of 500 ms. The stimulation frequency pattern is 1.12Hz(hertz), 2.24Hz,4.56Hz, 9.12Hz, 100Hz then 9.12Hz, 4.56Hz,2.28Hz,1.12Hz. This cycle will keep on continuing. An input voltage will be 4.2V(volt).
Gerät: Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)

This is a Small electronic circuit board with a minimal number of electronic components in it, which is powered by three zinc-air batteries. Each battery consists of 1.4v of charge. From this charge, the circuit produces a maximum voltage of 3.4V under no load condition.

The produced Voltage is driven as output by using the three stimulation wires, and the fourth insulated wire acts as a ground. The wires are Bio-compatible and do not have any impact when in contact with the human skin. The wire is attached with a needle to transfer the produced voltage into the nerves of the human ear. The sterilized needle (Titanium) is attached at the end of the wire through a snap fit ring. All the materials used are gone through necessary safety and performance testing including bio-compatibility and sterility testing, wherever necessary.
Schein-Komparator: Sham Arm
Sham arm: Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) device will stimulate centre of the left ear lobe to a pulse width of 500 ms at same pattern of stimulation frequency mentioned in active PENFS with an input voltage of 4.2V
Gerät: Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)

This is a Small electronic circuit board with a minimal number of electronic components in it, which is powered by three zinc-air batteries. Each battery consists of 1.4v of charge. From this charge, the circuit produces a maximum voltage of 3.4V under no load condition.

The produced Voltage is driven as output by using the three stimulation wires, and the fourth insulated wire acts as a ground. The wires are Bio-compatible and do not have any impact when in contact with the human skin. The wire is attached with a needle to transfer the produced voltage into the nerves of the human ear. The sterilized needle (Titanium) is attached at the end of the wire through a snap fit ring. All the materials used are gone through necessary safety and performance testing including bio-compatibility and sterility testing, wherever necessary.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Craving scores
Zeitfenster: 90 days

Change in craving scores measured with Penns Alcohol Craving Scale between baseline and equispaced 6 follow-ups (every 15 days) for 3 months.

Scale Information:

  1. Scale name: Penn Alcohol Craving Scale. It measures craving for alcohol.
  2. It is a 5-item scale. Each item score range is 0 to 6. So, Scale's total score range is 0 to 30.
  3. Score 0 signifies no craving and score 30 signifies maximum craving.
  4. There is no subscale.
90 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cue-induced craving resting state fMRI
Zeitfenster: 14 days

Change in Cue-induced craving as measured by the VICE protocol 6-minute Visual Image Induced Craving for Ethanol (VICE) paradigm fMRI and resting state fMRI neurohemodynamic changes in the dorsolateral prefrontal cortex, anterior cingulate cortex (ACC) and insular cortex (IC) after 14 days PENFS.

Time-Points are as follows:

Time 0 is on the day of recruitment. Time 1 is on Day 14 of recruitment.
14 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

DyAnsys, Inc.

Ermittler

  • Hauptermittler: Diptadhi Mukherjee, MBBS,DM, National Institute of Mental Health and Neuro sciences(NIMHANS)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Oktober 2019

Primärer Abschluss (Tatsächlich)

27. Dezember 2021

Studienabschluss (Tatsächlich)

27. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

25. September 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. September 2019

Zuerst gepostet (Tatsächlich)

27. September 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. März 2022

Zuletzt verifiziert

1. März 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CS010

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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