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Metaplasticity in Human Pharyngeal Motor Cortex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705936
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Shaheen Hamdy PhD FRCP, University of Manchester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Deglutition Physiology Device: rTMS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705936


Locations
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United Kingdom
Salford Royal Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 8Hd
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Shaheen Hamdy, PhD, FRCP The University of Manchester
More Information
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Responsible Party: Prof Shaheen Hamdy PhD FRCP, Professor of Neurogastroenterology, University of Manchester
ClinicalTrials.gov Identifier: NCT03705936    
Other Study ID Numbers: 2018-4900-7208
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Prof Shaheen Hamdy PhD FRCP, University of Manchester:
Non-invasive brain stimulation
Swallowing
Metaplasticity