Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex
ConditionHealthy Subjects (HS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Epilepsy
Cardiac pacemaker
Previous brain surgery
Previous swallowing problems
Trial design
Design model
Factorial
Treatments tested in this trial
repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)
DeviceThe 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.
pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)
DeviceThe 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 repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)
DeviceSham rTMS is delivered with the coil tilted to its side at 90 degrees and with the identical stimulation conditions as active 1 Hz rTMS.
sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)
DeviceFor sham pharyngeal stimulation, the same method including the insertion of the catherter will be employed without actual electrical stimulation.
Treatment groups
14 Participants
are divided into 3 treatment groupsGroup A: real rTMS + real PESExperimental treatment 2 interventions
Group B: sham rTMS + real PESSham comparator 2 interventions
Group C: real rTMS + sham PESSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Percentage change of the amplitude of PMEP after intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Time frame
Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention2
Percentage change of the latency of PMEP after intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Time frame
Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the interventionSecondary outcomes
1
Percentage change of the amplitude of TMEP after intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral TMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Time frame
Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention2
Percentage change of the latency of TMEP after intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral TMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Time frame
Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the interventionSponsors and contacts
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Source ClinicalTrials.gov