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tACS and tRNS Studies on Brain Control of Swallowing

Characterizing the Application of Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation Over Human Pharyngeal Motor Cortex

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040803
Enrollment
17
Registered
2019-08-01
Start date
2019-05-03
Completion date
2020-03-18
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Swallowing Disorder

Keywords

transcranial alternating current stimulation, transcranial random noise stimulation, frequency, full spectrum

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.

Interventions

DEVICETranscranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

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.

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

All people studied will have each of the five treatments separately over different days in random order.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history

Exclusion criteria

* a history of epilepsy * cardiac pacemaker * previous brain surgery * previous swallowing problems * risk of potential pregnancy * metal in the head or eyes * use of medication that acts on the central nervous system.

Design outcomes

Primary

MeasureTime frameDescription
Changes of pharyngeal motor evoked potential amplitudes (PMEPs)These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026