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Clinical Trials/NCT03705936
NCT03705936
Completed
Not Applicable

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

University of Manchester1 site in 1 country24 target enrollmentOctober 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deglutition
Sponsor
University of Manchester
Enrollment
24
Locations
1
Primary Endpoint
Pharyngeal motor evoked potentials (PMEPs)
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2018
End Date
February 26, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Shaheen Hamdy PhD FRCP

Professor of Neurogastroenterology

University of Manchester

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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