Metaplasticity in Human Pharyngeal Motor Cortex

NCT ID: NCT03705936

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2020-02-26

Brief Summary

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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.

Detailed Description

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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

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Deglutition Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham 1Hz rTMS--5Hz rTMS

Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

1Hz rTMS--5Hz rTMS

Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

1Hz rTMS--30-minute break--5Hz rTMS

Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

1Hz rTMS--60-minute break--5Hz rTMS

Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

Sham 5Hz rTMS--1Hz rTMS

Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

5Hz rTMS--1Hz rTMS

Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

5Hz rTMS--45-minute break--1Hz rTMS

Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

5Hz rTMS--90-minute break--1Hz rTMS

Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

Interventions

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rTMS

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Prof Shaheen Hamdy PhD FRCP

Professor of Neurogastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaheen Hamdy, PhD, FRCP

Role: PRINCIPAL_INVESTIGATOR

The University of Manchester

Locations

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Salford Royal Foundation Trust

Salford, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2018-4900-7208

Identifier Type: -

Identifier Source: org_study_id