Status:
WITHDRAWN
Brain Effect of Vagal Nerve Stimulation at Rest and Pain
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
King's College London
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Pain is a ubiquitous distressing sensory experience and is the most frequent symptom in numerous gastrointestinal disorders including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS...
Detailed Description
Following informed written consent and screening questionnaires to characterize psychophysiological traits including personality and anxiety/depression inventory, each subject will have a nasogastric ...
Eligibility Criteria
Inclusion
- Healthy participants (defined as those without pre-existing medical comorbidity) from staff, students and the local population of Queen Mary, University of London and/or King's College London
- Inclusion will be determined on the basis of availability. They should be able to attend the Denmark Hill King's College London Campus for 2 sessions.
- Women should be studied in the follicular phase of their menstrual cycle or taking oral contraceptives.
Exclusion
- Participants unable to provide informed consent
- Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
- Pregnant or breastfeeding females
- Participants unable to lie flat in the MRI scanner, suffer from claustrophobia or are unsuitable for MRI scanning due to contraindications, comorbidity or in situ metalwork
- Current smokers
- History of anxiety or depression, or hospital anxiety or depression score \>8
- History of drug or alcohol abuse
- Patients who have cardiovascular condition problems
- Patient with cochlear implants
- Recent nasal trauma, base of skull fracture and/or facial surgery that would contraindicate insertion of a nasogastric tube
- A positive urinary drugs screen
- Head circumference exceeding the limits of the scanner
- Not meeting any of the inclusion criteria above
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04282226
Start Date
March 16 2020
End Date
October 31 2022
Last Update
January 13 2023
Active Locations (1)
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1
Queen Mary University of London
London, UK, United Kingdom, E1 2AJ