DeglutitionNCT03705936
Metaplasticity in Human Pharyngeal Motor Cortex
A study testing rTMS in people with Deglutition and Physiology, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition, Physiology
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2018to 26 Feb 2020
- 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 volunteers aged 18 years old or above; and
- No medical complications or significant past medical history
Who cannot join
- History of epilepsy;
- Previous history of neurosurgery;
- Previous swallowing problem;
- Implanted brain electrodes, cardiac pacemaker; or
- Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal Foundation Trust
Salford, Greater Manchester, M6 8Hd
About this study
Official title: Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)
The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.
Read the detailed description
Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.
Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.
- Conditions
- Deglutition, Physiology
- Being tested
- rTMS
- Keywords
- Non-invasive brain stimulation, Swallowing, Metaplasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Sham 1Hz rTMS--5Hz rTMS | Sham comparator | Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS. Receives: Device: rTMS |
| 1Hz rTMS--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS. Receives: Device: rTMS |
| 1Hz rTMS--30-minute break--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS. Receives: Device: rTMS |
| 1Hz rTMS--60-minute break--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS. Receives: Device: rTMS |
| Sham 5Hz rTMS--1Hz rTMS | Sham comparator | Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS. Receives: Device: rTMS |
| 5Hz rTMS--1Hz rTMS | Experimental | Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS. Receives: Device: rTMS |
| 5Hz rTMS--45-minute break--1Hz rTMS | Experimental | Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS. Receives: Device: rTMS |
| 5Hz rTMS--90-minute break--1Hz rTMS | Experimental | Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharyngeal motor evoked potentials (PMEPs)
Motor evoked potentials from the pharynx will be elicited by single pulse transcranial magnetic stimulation and recorded.
Measured: Change from baseline up to 150 minutes after rTMS
Thenar (hand) motor evoked potentials (TMEPs)
Motor evoked potentials from the hand will be elicited by single pulse transcranial magnetic stimulation and recorded.
Measured: Change from baseline up to 150 minutes after rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start24 Oct 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeglutitionStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
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, PhD, FRCP, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705936
- Sponsor's protocol ID
- 2018-4900-7208
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2018
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)
- ClinicalTrials.gov ID
- NCT03705936
- Acronym / sponsor ID
- 2018-4900-7208
- Conditions
- Deglutition, Physiology
- Keywords
- Non-invasive brain stimulation, Swallowing, Metaplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 15 Oct 2018 (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.
The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.
Detailed description
Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.
Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sham 1Hz rTMS--5Hz rTMS | Sham comparator | Device: rTMSParticipants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS. |
| 1Hz rTMS--5Hz rTMS | Experimental | Device: rTMSParticipants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS. |
| 1Hz rTMS--30-minute break--5Hz rTMS | Experimental | Device: rTMSParticipants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS. |
| 1Hz rTMS--60-minute break--5Hz rTMS | Experimental | Device: rTMSParticipants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS. |
| Sham 5Hz rTMS--1Hz rTMS | Sham comparator | Device: rTMSParticipants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS. |
| 5Hz rTMS--1Hz rTMS | Experimental | Device: rTMSParticipants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS. |
| 5Hz rTMS--45-minute break--1Hz rTMS | Experimental | Device: rTMSParticipants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS. |
| 5Hz rTMS--90-minute break--1Hz rTMS | Experimental | Device: rTMSParticipants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers aged 18 years old or above; and
- No medical complications or significant past medical history
Key exclusion criteria (5 listed)
- History of epilepsy;
- Previous history of neurosurgery;
- Previous swallowing problem;
- Implanted brain electrodes, cardiac pacemaker; or
- Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold
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 |
|---|---|---|
| rTMSrTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction. | Device | 1Hz rTMS--30-minute break--5Hz rTMS, 1Hz rTMS--5Hz rTMS, 1Hz rTMS--60-minute break--5Hz rTMS, 5Hz rTMS--1Hz rTMS, 5Hz rTMS--45-minute break--1Hz rTMS, 5Hz rTMS--90-minute break--1Hz rTMS, Sham 1Hz rTMS--5Hz rTMS, Sham 5Hz rTMS--1Hz rTMS |
Primary outcome
Pharyngeal motor evoked potentials (PMEPs)
Time frame: Change from baseline up to 150 minutes after rTMS
Motor evoked potentials from the pharynx will be elicited by single pulse transcranial magnetic stimulation and recorded.
Thenar (hand) motor evoked potentials (TMEPs)
Time frame: Change from baseline up to 150 minutes after rTMS
Motor evoked potentials from the hand will be elicited by single pulse transcranial magnetic stimulation and recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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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, PhD, FRCP principal investigator
The 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 rTMS in people with Deglutition and Physiology, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharyngeal motor evoked potentials (PMEPs) (time frame: Change from baseline up to 150 minutes after rTMS). The study lists 2 primary outcomes in all. 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 4 Nov 2020.