TVNS and Upper GI Motility

NCT06700200 | Not Yet Recruiting

• 1 other identifier: NL86446.068.24
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract, in healthy subjects. Hypothesis: We hypothesize that tVNS will induce on average an excess of 1 additional phase III contraction of antral origin in the fasted period compared to sham stimulation.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Phase III Antral contractions

  A clinically meaningful increase in the number of phase III contractions of antral origin in the fasted period during the tVNS stimulation compared to the sham stimulation.

  During ADM

Secondary Outcomes (2)

• Motilin and pancreatic polypeptide levels

  During ADM

• Other ADM parameters

  During ADM

Study Arms (2)

taVNS

ACTIVE COMPARATOR

The vagus nerve will be stimulated transcutaneously. The concha of the left ear will be stimulated.

Device: taVNS

Sham stimulation

PLACEBO COMPARATOR

The vagus nerve will be stimulated transcutaneously. The concha of the left ear will be stimulated. The device is inactive.

Device: taVNS

Interventions

taVNS DEVICE

transauricular vagus nerve stimulation

Sham stimulation; taVNS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).
• Age between 18 and 55 years.
• Ability to understand and speak the Dutch language.

You may not qualify if:

• Pregnancy or lactation.
• Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility
• Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional of hierarchical position with regards to any of the study team members or their department.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Officials

• D Keszthelyi

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Hawinkels

CONTACT

+31 883887808; kimberly.hawinkels@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant and investigator will not know the randomization order of tVNS
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will receive two types of stimulation (i.e. taVNS vs sham) during a measurement with an antroduodenal manometry. The order of stimulation applied during each block is randomized.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share