Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex
Effect of Preconditioning of Human Pharyngeal Motor Cortex by Low Frequency Repetitive Transcranial Magnetic Stimulation on Enhancing Cortical Excitability Induced by Pharyngeal Electrical Stimulation
University of Manchester
14 participants
Sep 14, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research. There is no upper age limit for potential participants.
Exclusion Criteria8
- The presence or a history of:
- Epilepsy
- Cardiac pacemaker
- Previous brain surgery
- Previous swallowing problems
- The use of medication which acts on the central nervous system
- Any implanted metal in the head
- Pregnancy (self-declared)
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Interventions
The paradigm will be applied over the dominant cerebral hemisphere for 10 minutes (600 pulses) over the dominant pharyngeal motor cortex capped at 120% of pharyngeal resting motor threshold.
The PES (0.2-ms pulses, 280 V) was delivered at a set frequency (5 Hz), intensity (75% of maximal tolerated), and duration (10 minutes), which have been reported as the most effective parameters for PES.
Sham rTMS is delivered with the coil tilted to its side at 90 degrees and with the identical stimulation conditions as active 1 Hz rTMS.
For sham pharyngeal stimulation, the same method including the insertion of the catherter will be employed without actual electrical stimulation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06884488