tACS and tRNS Studies on Brain Control of Swallowing

University of Manchester

Status: Completed

Conditions: Dysphagia; Swallowing Disorder

Treatments: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04040803

2019-5932-10164

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

17 participants in 5 patient groups

10 Hz tACS

Experimental group

Description:

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.

Treatment:

Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

20 Hz tACS

Experimental group

Description:

Stimulation will be applied at 20 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 20 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

Treatment:

Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

70Hz tACS

Experimental group

Description:

Stimulation will be applied at 70 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 70 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

Treatment:

Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

0.1-640Hz tRNS

Experimental group

Description:

Stimulation will be applied at 0.1-640Hz tRNS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 0.1-640Hz tRNS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

Treatment:

Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

Sham

Sham Comparator group

Description:

Stimulation will be performed only for 10 s before the fade out, with 20 Hz tACS and an intensity of 1.5 mA (peak to peak). Sham condition will be applied over pseudo-stimulation of pharyngeal cortex region and contralateral supraorbital region.

Treatment:

Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)