Metaplasticity in Human Pharyngeal Motor Cortex

Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705936
• Other study ID #: 2018-4900-7208
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: November 2020
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition
• Physiology

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Salford Royal Foundation Trust	Salford	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharyngeal motor evoked potentials (PMEPs)	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
Primary	Thenar (hand) motor evoked potentials (TMEPs)	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