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Completed

NCT Number: NCT03705936

Metaplasticity in Human Pharyngeal Motor Cortex

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.

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Key information

Conditions

Deglutition Physiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal Foundation Trust

Salford, Greater Manchester, M6 8Hd, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers aged 18 years old or above; and
  • No medical complications or significant past medical history

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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