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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham 1Hz rTMS--5Hz rTMS | Sham Comparator | Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS. |
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| 1Hz rTMS--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS. |
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| 1Hz rTMS--30-minute break--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS. |
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| 1Hz rTMS--60-minute break--5Hz rTMS | Experimental | Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS. |
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| Sham 5Hz rTMS--1Hz rTMS | Sham Comparator | Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS. |
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| 5Hz rTMS--1Hz rTMS | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharyngeal motor evoked potentials (PMEPs) | Motor evoked potentials from the pharynx will be elicited by single pulse transcranial magnetic stimulation and recorded. | 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. | Change from baseline up to 150 minutes after rTMS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Hamdy, PhD, FRCP | The University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salford Royal Foundation Trust | Salford | Greater Manchester | M6 8Hd | United Kingdom |
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Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.
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| 5Hz rTMS--45-minute break--1Hz rTMS | Experimental | Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS. |
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| 5Hz rTMS--90-minute break--1Hz rTMS | Experimental | Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS. |
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