The Effects of Cerebellar rTMS on Brain Activity
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. Anatomical evidence exists, showing cerebellar outputs projecting to several cortical areas, including the primary motor cortex (M1). Moreover, brain imaging studies have shown activation of the cerebellum during swallowing using positron emission tomography (PET) and magnetic resonance imaging (MRI).
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. No imaging studies have been conducted which have looked at how the brain is affected by cerebellar rTMS.
The investigators hypothesise that cerebellar rTMS will cause increased activity in swallowing associated areas in the brain, including the cortex and brainstem
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Experiment The optimal motor stimulation sites for pharyngeal and thenar cortical areas and the cerebellum will be identified and marked using single pulse TMS with a coil. Anatomical landmarks will be used to help guide neuronavigation. The vertex (top) of the head will be identified with a tape measure as will the inion (the most prominent part at the back of the skull). Studies have demonstrated that pharyngeal (throat) and thenar (thumb) cortical areas are found in front and to the side of the vertex while both halves of the cerebellum lie below and to the side of the inion. The thenar resting motor threshold over the dominant pharyngeal hemisphere is required for calculation of cerebellar rTMS intensity.
Participants will then be randomly allocated to either real right sided cerebellar rTMS or sham (pretend) cerebellar rTMS on each visit. Each participant will undergo both procedures (real and sham) over the course of their involvement with the study. Real cerebellar rTMS will be delivered by holding the figure of eight coil flat against the head. It will be administered at 90% of thenar resting motor threshold at a frequency of 10 Hertz. Sham cerebellar rTMS will be delivered by holding the coil perpendicular to the scalp with only the edge of the coils making contact with the head. This technique has been used in previous studies and will ensure that no stimulation is delivered to the cerebellum.
After real or sham cerebellar rTMS, participants will have functional magnetic resonance imaging (fMRI) scans of their brains. During the scan participants will be asked to swallow water through a plastic tube. This will activate their brain swallowing centres. Each participant will be asked to complete five swallowing cycles. Each cycle will involve swallowing 10 times with a one second gap between swallows. Cycles will be separated by a 10 second period of rest.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M6 8HD
- Upper G.I laboratory, Salford Royal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy adults above 18 years of age
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Unilateral cerebellar rTMS
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250 pulses at 10 Hertz over the cerebellum
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Sham Comparator: Sham cerebellar rTMS
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Sham cerebellar rTMS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Differential blood flood (fMRI)
Time Frame: 15 minutes post cerebellar rTMS
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Differential blood flow in brain regions post cerebellar rTMS (compared to sham)
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15 minutes post cerebellar rTMS
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shaheen Hamdy, University of Manchester
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRAS 256390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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