NCT02620176

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

December 15, 2014

Last Update Submit

November 28, 2015

Conditions

Esophageal Diseases

Outcome Measures

Primary Outcomes (1)

  • Sensitisation to electrical stimuli in the proximal oesophagus following a distal oesophageal acid infusion in comparison to baseline

    Pain tolerance thresholds to electrical stimulation in the proximal oesophagus decrease following a distal oesophageal acid infusion due to central sensitisation and are defined as a reduction of \>6mA in thresholds. Prevention of sensitisation will be defined as this threshold not being met.

    90 minutes post acid infusion

Secondary Outcomes (4)

  • Sensitisation to electrical stimuli in the proximal oesophagus following a distal oesophageal acid infusion in comparison to baseline

    30 minutes post acid infusion

  • Sensitisation to electrical stimuli in the proximal oesophagus following a distal oesophageal acid infusion in comparison to baseline

    60 minutes post acid infusion

  • Effect of vagal nerve stimulation on cardiac vagal tone during stimulation in comparison to baseline

    30 minutes

  • Effect of vagal nerve stimulation on cardiac sympathetic index during stimulation in comparison to baseline

    30 minutes

Study Arms (2)

Transcutaneous vagal nerve stimulation

EXPERIMENTAL

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

Device: Transcutaneous vagal nerve stimulation

Sham vagal nerve stimulation

PLACEBO COMPARATOR

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.

Device: Transcutaneous vagal nerve stimulation

Interventions

Transcutaneous vagal nerve stimulationDEVICE

Trans-auricular vagal nerve stimulation

Also known as: NEMOS
Sham vagal nerve stimulationTranscutaneous vagal nerve stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute of Neurogastroenterology

London, London, E1 @AJ, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24870622BACKGROUND

Related Links

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Adam D Farmer, PhD MRCP

CONTACT

02088822640a.farmer@qmul.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD MRCP

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 2, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

GB(1)