Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 years and older
- Interested individuals recruited through hospital adverts, university website, or volunteer database
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
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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