Cerebellar Metaplasticity in the Swallowing Motor System

NCT06721533 | Not Yet Recruiting

• 1 other identifier: 341596
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Swallowing; Dysphagia

Outcome Measures

Primary Outcomes (2)

• Pharyngeal motor evoked potential (PMEP) amplitude

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

  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

  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

Study Arms (10)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Arm 3

EXPERIMENTAL

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

Arm 4

EXPERIMENTAL

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

Arm 5

EXPERIMENTAL

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

Arm 6

EXPERIMENTAL

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

Arm 7

EXPERIMENTAL

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

Arm 8

EXPERIMENTAL

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

Arm 9

EXPERIMENTAL

Most excitatory metaplastic protocol (comparing effects of arms 1-8 against one another) to right cerebellar hemisphere. Swallowing accuracy measurements.

Device: Cerebellar rTMS

Arm 10

EXPERIMENTAL

Single dose cerebellar rTMS to right hemisphere. Swallowing accuracy measurements.

Device: Cerebellar rTMS

Interventions

Cerebellar rTMS DEVICE

Cerebellar rTMS applied to pharyngeal area of right hemisphere

Arm 1; Arm 10; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8; Arm 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants \> 18 years of age

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manchester: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ayodele Sasegbon

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayodele Sasegbon

CONTACT

0161 789 7373; ayodele.sasegbon@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share