The Effects of Cerebellar rTMS on the BrainNCT05736380
The Effects of Cerebellar rTMS on Brain Activity
A study testing Cerebellar rTMS in people with The Effects of Cerebellar rTMS on the Brain, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Effects of Cerebellar rTMS on the Brain
- What is being tested?
- Cerebellar rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults above 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Upper G.I laboratory, Salford Royal Hospital
Manchester, Greater Manchester, M6 8HD
About this study
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
Read the 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.
- Being tested
- Cerebellar rTMS, Sham cerebellar rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar rTMSDevice
250 pulses at 10 Hertz over the cerebellum
Sham cerebellar rTMSDevice
Sham cerebellar rTMS
| Study group | Role | What they receive |
|---|---|---|
| Unilateral cerebellar rTMS | Active comparator | Not described Receives: Device: Cerebellar rTMS |
| Sham cerebellar rTMS | Sham comparator | Not described Receives: Device: Sham cerebellar rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential blood flood (fMRI)
Differential blood flow in brain regions post cerebellar rTMS (compared to sham)
Measured: 15 minutes post cerebellar rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Why it stopped: Requires funding to commence fMRI scan - funding awaited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effects of Cerebellar rTMS on the BrainStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Over the course of two visits to the laboratory, each participant will undergo either real or sham cerebellar rTMS. Afterwards they will have functional magnetic resonance imaging of their brains.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Shaheen Hamdy PhD FRCP, University of Manchester
- Investigators
- Shaheen Hamdy, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736380
- Sponsor's protocol ID
- IRAS 256390
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cerebellar rTMS on Brain Activity
- ClinicalTrials.gov ID
- NCT05736380
- Acronym / sponsor ID
- IRAS 256390
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Requires funding to commence fMRI scan - funding awaited
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Over the course of two visits to the laboratory, each participant will undergo either real or sham cerebellar rTMS. Afterwards they will have functional magnetic resonance imaging of their brains.
| Arm | Type | Receives |
|---|---|---|
| Unilateral cerebellar rTMS | Active comparator | Device: Cerebellar rTMS |
| Sham cerebellar rTMS | Sham comparator | Device: Sham cerebellar rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults above 18 years of age
Key exclusion criteria (6 listed)
- Epilepsy
- Cardiac pacemaker
- Previous brain surgery
- Previous swallowing problems
- The use of medication which acts on the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebellar rTMS250 pulses at 10 Hertz over the cerebellum | Device | Unilateral cerebellar rTMS |
| Sham cerebellar rTMSSham cerebellar rTMS | Device | Sham cerebellar rTMS |
Primary outcome
Differential blood flood (fMRI)
Time frame: 15 minutes post cerebellar rTMS
Differential blood flow in brain regions post cerebellar rTMS (compared to sham)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Hamdy principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellar rTMS in people with The Effects of Cerebellar rTMS on the Brain, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential blood flood (fMRI) (time frame: 15 minutes post cerebellar rTMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.