tACS and tRNS Studies on Brain Control of Swallowing

March 27, 2020 updated by: Prof Shaheen Hamdy PhD FRCP, University of Manchester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M6 8HD
        • Upper G.I laboratory, Salford Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 Hz tACS

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.
Device: Transcranial 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.
Experimental: 20 Hz tACS

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.
Device: Transcranial 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.
Experimental: 70Hz tACS

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.
Device: Transcranial 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.
Experimental: 0.1-640Hz tRNS

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.
Device: Transcranial 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.
Sham Comparator: Sham

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.
Device: Transcranial 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Principal Investigator: Shaheen Hamdy, MD,PhD, GI-sciences, Salford Royal NHS Foundation Trust, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

March 18, 2020

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-5932-10164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The Gastrointestinal Sciences research team at the University of Manchester will have access to participants' identifiable information, but it will be anonymized as soon as participants are enrolled in this study. Representatives from the University of Manchester and regulatory authorities will have access to the anonymised data if required for auditing and monitoring process. However, participants' anonymised consent form, contact details, and data collected for this study will be retained for 5 years.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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