Metaplasticity in Human Pharyngeal Motor Cortex

November 3, 2020 updated by: Prof Shaheen Hamdy PhD FRCP, University of Manchester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8Hd
        • Salford Royal Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham 1Hz rTMS--5Hz rTMS
Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 1Hz rTMS--5Hz rTMS
Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 1Hz rTMS--30-minute break--5Hz rTMS
Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 1Hz rTMS--60-minute break--5Hz rTMS
Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
SHAM_COMPARATOR: Sham 5Hz rTMS--1Hz rTMS
Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 5Hz rTMS--1Hz rTMS
Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 5Hz rTMS--45-minute break--1Hz rTMS
Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
EXPERIMENTAL: 5Hz rTMS--90-minute break--1Hz rTMS
Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.
Device: rTMS
rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline up to 150 minutes after rTMS
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.
Change from baseline up to 150 minutes after rTMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Principal Investigator: Shaheen Hamdy, PhD, FRCP, The University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 24, 2018

Primary Completion (ACTUAL)

February 26, 2020

Study Completion (ACTUAL)

February 26, 2020

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (ACTUAL)

October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-4900-7208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physiology

Clinical Trials on rTMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe