Healthy Subjects (HS)NCT06884488
Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex
A study testing repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) and pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) in people with Healthy Subjects (HS), run by University of Manchester at 1 site in United Kingdom.
Trial summary
The goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is: Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) and pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2024to 31 Aug 2025
- 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 over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research. There is no upper age limit for potential participants.
Who cannot join
- The presence or a history of:
- 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)
Trial locations and contacts
1 site in 1 country.
Ayodele Sasegbon, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Manchester
Manchester, M6 8JH
Shaheen Professor Hamdy, PhD, 44 07973665987, shaheen.hamdy@manchester.ac.uk
About this study
Official title: Effect of Preconditioning of Human Pharyngeal Motor Cortex by Low Frequency Repetitive Transcranial Magnetic Stimulation on Enhancing Cortical Excitability Induced by Pharyngeal Electrical Stimulation
The goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is:
Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric pharyngeal areas enhance the activating effects of pharyngeal electrical stimulation (PES) on cortical excitability?
Read more
Participants will:
- Visit the department three times, with at least a one-week gap between visits.
- Undergo baseline measurements for Pharyngeal motor evoked potential (PMEP) and Thenar motor evoked potential (TMEP), involving an electromyography (EMG) pharyngeal catheter inserted into the pharynx and gel electrodes to detect muscle activity.
- Be randomly allocated to one of the three preconditioning-conditioning procedures during each visit : 1Hz rTMS followed by 5Hz PES, sham 1Hz rTMS followed by 5Hz PES, and 1Hz rTMS followed by sham 5Hz PES
- Real rTMS will involve a figure-of-eight coil flat against the head delivering 1Hz stimulation at 90% of the thenar resting motor threshold.
- Sham rTMS will involve holding the coil perpendicular to the scalp to prevent brain stimulation.
- PES will involve a catheter delivering 0.2-ms pulses at 5Hz and 75% of the maximal tolerated intensity for 10 minutes. Sham PES will involve deactivating the current generator.
- Complete PMEP and TMEP measurements at baseline before intervention and every 15 minutes from 0 - 60 minutes after the rTMS-PES procedure.
- Complete a survey regarding tolerability and safety at the end of each visit.
Read the detailed description
1 Study design This is a cross-over study with the order of experimental conditions randomized for each participant. The randomisation will be conducted using a randomisation program (Stats Direct, v2.7.8, StatsDirect Ltd, Altrincham, UK). Each condition will be given on separate days, at least one week apart.
- Participants Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research.
- Informed consent A participant information sheet will be given to each participant. A researcher with up-to-date Good Clinical Practice (GCP) training will be responsible for obtaining consent from the participants. He/she will explain the study purpose and nature and experimental procedures verbally to the participants. The participants will be given sufficient time (at least 24 hours) to read and digest the written information and discuss with the researcher about the study. The researcher will ensure the participants are volunteering to participate, understand the purpose and nature, experimental procedures, benefits and risks of the study before obtaining written consent from them. The participants should understand that they have the rights to withdraw from the study anytime throughout the study.
- Study Procedures
Participants will undergo either active or sham preconditioned 1 Hz rTMS interventions with 30 min intervals before active or sham 5 Hz PES (Fig 1). Each session involved:
- A baseline measurement of PMEP and TMEP.
- Application of (active/sham) 1 Hz rTMS (preconditioning).
- A resting interval (30 minutes).
- Application of (active/sham) 5 Hz PES (conditioning).
- Measurement of PMEP and TMEP at multiple time points (immediately, 15, 30, 45, and 60 minutes post-PES).
- End of study The study will come to an end after the period of data collection and analysis by the end of August 2025.
- Withdraw consent Participants are able to withdraw consent at any time they wish. This will be stressed to all participants by members of the research team. Should this happen, their data will be retained with permission from the subject and they will be removed from the study.
As only healthy participants will be recruited for this study, no participant is expected to lose the capacity to consent during the course of the study. However, if for any reason a loss of capacity is suspected, the participant will be excluded from the study.
- Conditions
- Healthy Subjects (HS)
- Being tested
- repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK), pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK), sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK), sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)Device
The paradigm will be applied over the dominant cerebral hemisphere for 10 minutes (600 pulses) over the dominant pharyngeal motor cortex capped at 120% of pharyngeal resting motor threshold.
pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)Device
The PES (0.2-ms pulses, 280 V) was delivered at a set frequency (5 Hz), intensity (75% of maximal tolerated), and duration (10 minutes), which have been reported as the most effective parameters for PES.
sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)Device
Sham rTMS is delivered with the coil tilted to its side at 90 degrees and with the identical stimulation conditions as active 1 Hz rTMS.
sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)Device
For sham pharyngeal stimulation, the same method including the insertion of the catherter will be employed without actual electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| real rTMS + real PES | Experimental | Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES. Receives: Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK); Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) |
| sham rTMS + real PES | Sham comparator | Participants will receive sham 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES. Receives: Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK); Device: sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) |
| real rTMS + sham PES | Sham comparator | Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive sham 5Hz PES. Receives: Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK); Device: sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of the amplitude of PMEP after intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Measured: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Percentage change of the latency of PMEP after intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Measured: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Secondary outcomes (2)
Percentage change of the amplitude of TMEP after intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral TMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Measured: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Percentage change of the latency of TMEP after intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral TMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Measured: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start14 Sep 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 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, PhD, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884488
- Sponsor's protocol ID
- 2024-20990-37010
- Status last verified
- Sep 2024
- First submitted
- 27 Feb 2025
- Last updated
- 19 Mar 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preconditioning of Human Pharyngeal Motor Cortex by Low Frequency Repetitive Transcranial Magnetic Stimulation on Enhancing Cortical Excitability Induced by Pharyngeal Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06884488
- Acronym / sponsor ID
- 2024-20990-37010
- Conditions
- Healthy Subjects (HS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 19 Mar 2025 (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 goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is:
Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric pharyngeal areas enhance the activating effects of pharyngeal electrical stimulation (PES) on cortical excitability?
Participants will:
- Visit the department three times, with at least a one-week gap between visits.
- Undergo baseline measurements for Pharyngeal motor evoked potential (PMEP) and Thenar motor evoked potential (TMEP), involving an electromyography (EMG) pharyngeal catheter inserted into the pharynx and gel electrodes to detect muscle activity.
- Be randomly allocated to one of the three preconditioning-conditioning procedures during each visit : 1Hz rTMS followed by 5Hz PES, sham 1Hz rTMS followed by 5Hz PES, and 1Hz rTMS followed by sham 5Hz PES
- Real rTMS will involve a figure-of-eight coil flat against the head delivering 1Hz stimulation at 90% of the thenar resting motor threshold.
- Sham rTMS will involve holding the coil perpendicular to the scalp to prevent brain stimulation.
- PES will involve a catheter delivering 0.2-ms pulses at 5Hz and 75% of the maximal tolerated intensity for 10 minutes. Sham PES will involve deactivating the current generator.
- Complete PMEP and TMEP measurements at baseline before intervention and every 15 minutes from 0 - 60 minutes after the rTMS-PES procedure.
- Complete a survey regarding tolerability and safety at the end of each visit.
Detailed description
1 Study design This is a cross-over study with the order of experimental conditions randomized for each participant. The randomisation will be conducted using a randomisation program (Stats Direct, v2.7.8, StatsDirect Ltd, Altrincham, UK). Each condition will be given on separate days, at least one week apart.
- Participants Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research.
- Informed consent A participant information sheet will be given to each participant. A researcher with up-to-date Good Clinical Practice (GCP) training will be responsible for obtaining consent from the participants. He/she will explain the study purpose and nature and experimental procedures verbally to the participants. The participants will be given sufficient time (at least 24 hours) to read and digest the written information and discuss with the researcher about the study. The researcher will ensure the participants are volunteering to participate, understand the purpose and nature, experimental procedures, benefits and risks of the study before obtaining written consent from them. The participants should understand that they have the rights to withdraw from the study anytime throughout the study.
- Study Procedures
Participants will undergo either active or sham preconditioned 1 Hz rTMS interventions with 30 min intervals before active or sham 5 Hz PES (Fig 1). Each session involved:
- A baseline measurement of PMEP and TMEP.
- Application of (active/sham) 1 Hz rTMS (preconditioning).
- A resting interval (30 minutes).
- Application of (active/sham) 5 Hz PES (conditioning).
- Measurement of PMEP and TMEP at multiple time points (immediately, 15, 30, 45, and 60 minutes post-PES).
- End of study The study will come to an end after the period of data collection and analysis by the end of August 2025.
- Withdraw consent Participants are able to withdraw consent at any time they wish. This will be stressed to all participants by members of the research team. Should this happen, their data will be retained with permission from the subject and they will be removed from the study.
As only healthy participants will be recruited for this study, no participant is expected to lose the capacity to consent during the course of the study. However, if for any reason a loss of capacity is suspected, the participant will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| real rTMS + real PES | Experimental | Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK), Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES. |
| sham rTMS + real PES | Sham comparator | Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK), Device: sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)Participants will receive sham 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES. |
| real rTMS + sham PES | Sham comparator | Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK), Device: sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive sham 5Hz PES. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research. There is no upper age limit for potential participants.
Key exclusion criteria (8 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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)The paradigm will be applied over the dominant cerebral hemisphere for 10 minutes (600 pulses) over the dominant pharyngeal motor cortex capped at 120% of pharyngeal resting motor threshold. | Device | real rTMS + real PES, real rTMS + sham PES |
| pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)The PES (0.2-ms pulses, 280 V) was delivered at a set frequency (5 Hz), intensity (75% of maximal tolerated), and duration (10 minutes), which have been reported as the most effective parameters for PES. | Device | real rTMS + real PES, sham rTMS + real PES |
| sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)Sham rTMS is delivered with the coil tilted to its side at 90 degrees and with the identical stimulation conditions as active 1 Hz rTMS. | Device | sham rTMS + real PES |
| sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)For sham pharyngeal stimulation, the same method including the insertion of the catherter will be employed without actual electrical stimulation. | Device | real rTMS + sham PES |
Primary outcome
Percentage change of the amplitude of PMEP after intervention
Time frame: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Percentage change of the latency of PMEP after intervention
Time frame: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
2 secondary outcomes
Percentage change of the amplitude of TMEP after intervention
Time frame: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Percentage change of the latency of TMEP after intervention
Time frame: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- 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.
Ayodele Sasegbon, PhD contact
Shaheen Hamdy, PhD 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 repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) and pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) in people with Healthy Subjects (HS), 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 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 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?
Contact Meng Dai, PhD (44 7585922413, meng.dai@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of the amplitude of PMEP after intervention (time frame: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention). 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 19 Mar 2025.