Metaplasticity in Human Pharyngeal Motor Cortex

Not Applicable

Completed

• Conditions: Deglutition; Physiology
• Interventions: Device: rTMS

• Registration Number: NCT03705936
• Lead Sponsor: University of Manchester

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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-15
• Study Start: 2018-10-24
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham 1Hz rTMS--5Hz rTMS	rTMS	Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.
1Hz rTMS--30-minute break--5Hz rTMS	rTMS	Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.
Sham 5Hz rTMS--1Hz rTMS	rTMS	Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.
5Hz rTMS--45-minute break--1Hz rTMS	rTMS	Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.
1Hz rTMS--5Hz rTMS	rTMS	Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.
1Hz rTMS--60-minute break--5Hz rTMS	rTMS	Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.
5Hz rTMS--1Hz rTMS	rTMS	Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.
5Hz rTMS--90-minute break--1Hz rTMS	rTMS	Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.

Primary Outcome Measures

Name	Time	Method
Pharyngeal motor evoked potentials (PMEPs)	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)	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.

Trial Locations

Locations (1)

Salford Royal Foundation Trust; 🇬🇧 Salford, Greater Manchester, United Kingdom