Cerebellar Metaplasticity in the Swallowing Motor System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester

About this trial

Dysphagia is common and leads to significant morbidity and mortality within healthcare settings. Current approaches to dysphagia management involve altering the consistency of food and fluids. However, these approaches are not supported by a robust evidence base. Repetitive transcranial magnetic stimulation (rTMS) offers a non-invasive way to manipulate neuroelectric activity within the brain. Within the swallowing motor system, rTMS at a frequency of 5Hertz (Hz) and above is excitatory while 1Hz is suppressive.

Cortical rTMS targeting pharyngeal motor areas can alter brain activity and swallowing behaviour in healthy participants and has been shown to improve post-stroke dysphagia (PSD). Despite this, it has a small seizure risk. Cerebellar rTMS is a newer and safer technique which is more easily targeted and is effective at altering swallowing related brain activity and behaviour. Recent studies have also shown it can improve PSD.

Critically, individual responsiveness to rTMS is variable, potentially reducing its effectiveness. Metaplasticity whereby the brain is preconditioned with a neuroelectric stimulus before the treating stimulus is administered is a potential way of reducing variability. Metaplasticity has recently been shown to improve responses within the swallowing motor system following cortical rTMS. However, to date no cerebellar rTMS study has applied this approach. This is a gap in our understanding which will need to be addressed.

The overarching aim of the study is to develop a less variable and more effective treatment for neurogenic dysphagia. More specifically the study objectives are to establish:

1. Whether 10Hz Cer-rTMS delivered over hemispheric pharyngeal areas can induce SMS metaplastic changes in healthy participants. 2. If a cerebellar rTMS metaplastic stimulation protocol can affect swallowing behaviour.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Epilepsy

Cardiac pacemaker

Previous brain surgery

Previous swallowing problems

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cerebellar rTMS

    Device

    Cerebellar rTMS applied to pharyngeal area of right hemisphere

Treatment groups

20 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Group D: Arm 4Experimental treatment 1 intervention
Group E: Arm 5Experimental treatment 1 intervention
Group F: Arm 6Experimental treatment 1 intervention
Group G: Arm 7Experimental treatment 1 intervention
Group H: Arm 8Experimental treatment 1 intervention
Group I: Arm 9Experimental treatment 1 intervention
Group J: Arm 10Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharyngeal motor evoked potential (PMEP) amplitude

PMEP amplitude measured using single pulse transcranial magnetic stimulation over pharyngeal motor areas of the cortex and cerebellum

Time frame
10 measurements made at baseline, 0 minutes post stimulation, 15 minutes post stimulation, 30 minutes post stimulation, 45 minutes post stimulation and 60 minutes post stimulation
2

Swallowing accuracy

Swallowing accuracy measured using a reaction time task

Time frame
10 measurements made at baseline, 0 minutes post stimulation, 15 minutes post stimulation, 30 minutes post stimulation, 45 minutes post stimulation and 60 minutes post stimulation

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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