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The Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Oesophageal Pain Hypersensitivity

NCT ID: NCT02620176

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-02-29

Brief Summary

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We are evaluating the role of transcutaneous electrical vagal nerve stimulation in the prevention of oesophageal pain hypersensitivity using a validated human model in healthy volunteers.

Detailed Description

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Chronic oesophageal pain is a symptomatic feature of disorders such as erosive oesophagitis, non-erosive reflux disease and non-cardiac chest pain. Patients often display heightened sensitivity to intra-oesophageal stimuli, which is referred to as oesophageal pain hypersensitivity. However, the experience of oesophageal pain is highly individual with a multitude of factors proposed to account for this variability. Amongst the physiological factors is the autonomic nervous system (ANS). The ANS has been postulated to play a pivotal role in the modulation of pain through its multiple interactions with pain processing. The ANS has two broadly antithetic branches, the parasympathetic nervous system (PNS) and the sympathetic nervous system (SNS). The primary neural substrate of the PNS is the vagus nerve. The vagus nerve is increasingly considered to play an integral role in modulating oesophageal pain. Electrical vagal nerve stimulation (VNS) was first used in humans in 1988 and is an efficacious treatment for drug resistant epilepsy. Traditional VNS is undertaken in a procedure where a bipolar helical electrode is placed around the cervical vagal nerve, which is connected to a pulse generator placed in subcutaneous pocket in the chest, not dissimilar to a cardiac pacemaker. However, this method of VNS necessitates surgical implantation with its attendant risks and complications. Recently, an external transcutaneous VNS (t-VNS) system, consisting of an earplug-like electrode to interface with the concha of the outer ear and a handheld battery-powered electrical stimulator, has become commercially available (NEMOS system). The auricular branch of the vagus nerve innervates the concha of the ear and is located directly under the skin, making it a suitable target for transcutaneous stimulation. t-VNS has been demonstrated to be safe, well tolerated and have a high degree of user-friendliness. A preliminary study has reported that t-VNS reduces sensitivity to heat pain in healthy volunteers. Furthermore, recent studies have demonstrated that t-VNS patterns of cerebral activation, as determined by functional magnetic resonance imaging, were similar to those evoked by traditional VNS. Thus, VNS per se represents an attractive proposition for investigating the role of the PNS in oesophageal pain and t-VNS specifically, a viable, safe and acceptable technology for achieving this. The pivotal experiments evaluating the analgesic role of VNS in the development of acid induced oesophageal pain hypersensitivity have not been conducted. Using the aforementioned model of oesophageal pain hypersensitivity, we seek to determine the analgesic effect of t-VNS.

Conditions

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Esophageal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcutaneous vagal nerve stimulation

Active vagal nerve stimulation to the left auricular branch of the vagus nerve.

Group Type EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

Trans-auricular vagal nerve stimulation

Sham vagal nerve stimulation

Placebo vagal nerve stimulation stimulation. The stimulator is attached to the left ear, but rotated 180 degrees, so that it is not stimulating the auricular branch of the vagal nerve.

Group Type PLACEBO_COMPARATOR

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

Trans-auricular vagal nerve stimulation

Interventions

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Transcutaneous vagal nerve stimulation

Trans-auricular vagal nerve stimulation

Intervention Type DEVICE

Other Intervention Names

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NEMOS

Eligibility Criteria

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Inclusion Criteria

* Ability to provide Informed written consent
* Healthy volunteers aged 18-65, who have no medical history

* Subjects unable to provide informed consent.
* Subjects with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease).
* Pregnant females to prevent any confounding effects on pregnancy related nausea.
* Subjects who suffer from reflux disease
* Subject who take any medication, including over the counter preparations
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wingate Institute of Neurogastroenterology

OTHER

Sponsor Role lead

Responsible Party

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Adam Farmer

PhD MRCP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wingate Institute of Neurogastroenterology

London, London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Adam D Farmer, PhD MRCP

Role: CONTACT

[email protected]
02088822640

Facility Contacts

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ADam Farmer, PhD MRCP

Role: primary

[email protected]
+442078822640

Susan Surguy, PhD

Role: backup

[email protected]
+442078822645

References

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Botha C, Farmer AD, Nilsson M, Brock C, Gavrila AD, Drewes AM, Knowles CH, Aziz Q. Preliminary report: modulation of parasympathetic nervous system tone influences oesophageal pain hypersensitivity. Gut. 2015 Apr;64(4):611-7. doi: 10.1136/gutjnl-2013-306698. Epub 2014 May 28.

Reference Type BACKGROUND
PMID: 24870622 (View on PubMed)

Related Links

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http://www.cerbomed.com

Description: Vagal nerve stimulator information

Other Identifiers

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Farmer-2

Identifier Type: -

Identifier Source: org_study_id