Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06884488

Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex

Led by University of Manchester · Updated on 2025-03-19

14

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is: Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric pharyngeal areas enhance the activating effects of pharyngeal electrical stimulation (PES) on cortical excitability? Participants will: * Visit the department three times, with at least a one-week gap between visits. * Undergo baseline measurements for Pharyngeal motor evoked potential (PMEP) and Thenar motor evoked potential (TMEP), involving an electromyography (EMG) pharyngeal catheter inserted into the pharynx and gel electrodes to detect muscle activity. * Be randomly allocated to one of the three preconditioning-conditioning procedures during each visit : 1Hz rTMS followed by 5Hz PES, sham 1Hz rTMS followed by 5Hz PES, and 1Hz rTMS followed by sham 5Hz PES 1. Real rTMS will involve a figure-of-eight coil flat against the head delivering 1Hz stimulation at 90% of the thenar resting motor threshold. 2. Sham rTMS will involve holding the coil perpendicular to the scalp to prevent brain stimulation. 3. PES will involve a catheter delivering 0.2-ms pulses at 5Hz and 75% of the maximal tolerated intensity for 10 minutes. Sham PES will involve deactivating the current generator. * Complete PMEP and TMEP measurements at baseline before intervention and every 15 minutes from 0 - 60 minutes after the rTMS-PES procedure. * Complete a survey regarding tolerability and safety at the end of each visit.

CONDITIONS

Official Title

Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 18 years and older
  • Interested individuals recruited through hospital adverts, university website, or volunteer database
Not Eligible

You will not qualify if you...

  • History or presence of epilepsy
  • Having a cardiac pacemaker
  • Previous brain surgery
  • Previous swallowing problems
  • Use of medication acting on the central nervous system
  • Any implanted metal in the head
  • Pregnancy (self-declared)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Manchester

Manchester, United Kingdom, M6 8JH

Actively Recruiting

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Research Team

M

Meng Dai, PhD

CONTACT

A

Ayodele Sasegbon, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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