An interventional study of Cerebellar rTMS in Swallowing and Dysphagia, sponsored by University of Manchester. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Manchester · Not applicable, Interventional, and Other
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:
723 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 482 interventional studies indexed under Deglutition Disorders.
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Healthy participants > 18 years of age
Exclusion Criteria:
Exclusion criteria will be the presence or a history of:
1\. Real 10 Hz cerebellar rTMS (250 pulses) to the right cerebellar hemisphere immediately followed by 1 Hz cerebellar rTMS (600 pulses) to the same area. Pharyngeal motor evoked potential (PMEP) amplitude measured
Device: Cerebellar rTMS
2\. Sham 10 Hz cerebellar rTMS (250 pulses) to the right cerebellar hemisphere immediately followed by 1 Hz cerebellar rTMS (600 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
3\. Real 10 Hz cerebellar rTMS (250 pulses) to the right cerebellar hemisphere followed after 45 minutes by 1 Hz cerebellar rTMS (600 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
4\. Real 10 Hz cerebellar rTMS (250 pulses) to the right cerebellar hemisphere followed after 90 minutes by 1 Hz cerebellar rTMS (600 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
5\. Real 1 Hz cerebellar rTMS (600 pulses) to the right cerebellar hemisphere immediately followed by 10 Hz cerebellar rTMS (250 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
6\. Sham 1 Hz cerebellar rTMS (600 pulses) to the right cerebellar hemisphere immediately followed by 10 Hz cerebellar rTMS (250 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
7\. Real 1 Hz cerebellar rTMS (600 pulses) to the right cerebellar hemisphere followed after 30 minutes by 10 Hz cerebellar rTMS (250 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
8\. Real 1 Hz cerebellar rTMS (600 pulses) to the right cerebellar hemisphere followed after 60 minutes by 10 Hz cerebellar rTMS (250 pulses) to the same area. PMEP amplitude measured
Device: Cerebellar rTMS
Most excitatory metaplastic protocol (comparing effects of arms 1-8 against one another) to right cerebellar hemisphere. Swallowing accuracy measurements.
Device: Cerebellar rTMS
Single dose cerebellar rTMS to right hemisphere. Swallowing accuracy measurements.
Device: Cerebellar rTMS
Cerebellar rTMS applied to pharyngeal area of right hemisphere
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
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
No study locations are listed for this record.
Plan to share: No — No identifiable data pertaining to individual participants will be shared with other researchers
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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