The Effects of Bilateral Cerebellar rTMS on Cortical Function

NCT03831789 | Completed

• 1 other identifier: IRAS 256171
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing function is controlled by two swallowing centres (one on each half of the brain). There is a dominant and non-dominant swallowing centre. Damage to any part of the brain can lead to swallowing problems, for example in strokes. Recovery of the ability to swallow is associated with increased activity (compensation) over the undamaged centre. The cerebellum is an area of the brain involved in the control and modulation of muscle movements. It is found at the back of the skull. Over the past few years studies have tried to improve swallowing function using techniques to stimulate regions of the brain and encourage compensation. Repetitive transcranial magnetic stimulation (rTMS) is a technique which can temporarily increase or suppress activity over regions of the brain. This study will use cerebellar rTMS to attempt to increase activity over the cortical swallowing centres. It will also temporarily suppress activity over the dominant swallowing centre (a virtual lesion) before using cerebellar targeted rTMS to attempt to reverse this suppressive electrical and behavioural effect. The investigators aim to compare the effectiveness of rTMS over the two halves of the cerebellum to rTMS over one half of the cerebellum in increasing activity over the swallowing centres and reversing the suppressive effects of low frequency rTMS 'virtual lesion' over the dominant swallowing centre.

Conditions

Dysphagia; Swallowing Disorder

Outcome Measures

Primary Outcomes (2)

• PMEP

  Pharyngeal motor evoked potential amplitude (PMEP) amplitude

  Every 15 minutes for an hour after the intervention.

• Swallowing behaviour

  Swallowing accuracy (number of correct swallows on target out of 10 using a swallowing reaction time task)

  Every 15 minutes for an hour after the intervention.

Study Arms (2)

Unilateral cerebellar rTMS

ACTIVE COMPARATOR

Device: Cerebellar targeted rTMS

Bilateral cerebellar rTMS

EXPERIMENTAL

Device: Cerebellar targeted rTMS

Interventions

Cerebellar targeted rTMS DEVICE

10 Hz cerebellar rTMS (250 pulses)

Bilateral cerebellar rTMS; Unilateral cerebellar rTMS

Eligibility Criteria

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

You may qualify if:

• Adults above 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Upper G.I laboratory, Salford Royal Hospital

Manchester, Greater Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaheen Hamdy

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be masked as to which of the three study arms they have been allocated. All participants over the course of three visits will either have: unilateral cerebellar rTMS or bilateral cerebellar rTMS. However, as specified earlier the order in which they will receive these interventions will be randomly allocated.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants over the course of three visits will either have: unilateral cerebellar rTMS or bilateral cerebellar rTMS. However, the order in which they will receive these interventions will be randomly allocated.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: April 8, 2019
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)