Brief Summary

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory. Swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. Until now, there are no studies investigating whether tACS and tRNS can have a beneficial effect on swallowing function in human. Our aim is to examine the effects of different strengths of tACS and tRNS to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders. Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2019

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

April 25, 2019

Completed

8 days until next milestone

Study Start

First participant enrolled

May 3, 2019

Completed

3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed

Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

April 25, 2019

Last Update Submit

March 27, 2020

Conditions

Dysphagia Swallowing Disorder

Keywords

transcranial alternating current stimulationtranscranial random noise stimulationfrequencyfull spectrum

Outcome Measures

Primary Outcomes (1)

Changes of pharyngeal motor evoked potential amplitudes (PMEPs)
Cortical excitability of the pharyngeal motor cortices are being assessed as the primary endpoints. Therefore, the changes in EMG pharyngeal motor evoked potential amplitudes (PMEPs) following the intervention applied to pharyngeal motor cortex are being collected.
These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.

Study Arms (5)

10 Hz tACS

EXPERIMENTAL

Stimulation will be applied at 10 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 10 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.