Cerebellar Metaplasticity in the Swallowing Motor System

Sponsor
University of Manchester
Study ID
NCT06721533
Status
Not Yet Recruiting

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Conditions

  • Dysphagia
  • Swallowing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cerebellar rTMS — DEVICE
    Cerebellar rTMS applied to pharyngeal area of right hemisphere

Study Details

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.

Key Dates

First listed
Dec 6, 2024
Start date
Dec 20, 2024
Status verified
Dec 2024
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Arm 1
    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
  • Experimental: Arm 2
    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
  • Experimental: Arm 3
    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
  • Experimental: Arm 4
    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
  • Experimental: Arm 5
    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
  • Experimental: Arm 6
    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
  • Experimental: Arm 7
    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
  • Experimental: Arm 8
    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
  • Experimental: Arm 9
    Most excitatory metaplastic protocol (comparing effects of arms 1-8 against one another) to right cerebellar hemisphere. Swallowing accuracy measurements.
  • Experimental: Arm 10
    Single dose cerebellar rTMS to right hemisphere. Swallowing accuracy measurements.

Primary Outcome Measure

Pharyngeal motor evoked potential (PMEP) amplitude [ 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 ]

Central Contacts

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