Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-02-27 @ 4:41 AM
Study NCT ID:
NCT04040803
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2019-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tACS and tRNS Studies on Brain Control of Swallowing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-29', 'releaseDate': '2022-11-30'}, {'resetDate': '2025-04-17', 'releaseDate': '2025-03-31'}], 'estimatedResultsFirstSubmitDate': '2022-11-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All people studied will have each of the five treatments separately over different days in random order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of pharyngeal motor evoked potential amplitudes (PMEPs)', 'timeFrame': 'These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial alternating current stimulation', 'transcranial random noise stimulation', 'frequency', 'full spectrum'], 'conditions': ['Dysphagia', 'Swallowing Disorder']}, 'referencesModule': {'references': [{'pmid': '27242932', 'type': 'BACKGROUND', 'citation': 'Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.'}, {'pmid': '28709880', 'type': 'BACKGROUND', 'citation': 'Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.'}, {'pmid': '15335461', 'type': 'BACKGROUND', 'citation': 'Herrmann CS, Munk MH, Engel AK. Cognitive functions of gamma-band activity: memory match and utilization. Trends Cogn Sci. 2004 Aug;8(8):347-55. doi: 10.1016/j.tics.2004.06.006.'}, {'pmid': '11584308', 'type': 'BACKGROUND', 'citation': 'Engel AK, Fries P, Singer W. Dynamic predictions: oscillations and synchrony in top-down processing. Nat Rev Neurosci. 2001 Oct;2(10):704-16. doi: 10.1038/35094565.'}, {'pmid': '26225845', 'type': 'BACKGROUND', 'citation': 'Pollok B, Boysen AC, Krause V. The effect of transcranial alternating current stimulation (tACS) at alpha and beta frequency on motor learning. Behav Brain Res. 2015 Oct 15;293:234-40. doi: 10.1016/j.bbr.2015.07.049. Epub 2015 Jul 28.'}, {'pmid': '23219965', 'type': 'BACKGROUND', 'citation': 'Wach C, Krause V, Moliadze V, Paulus W, Schnitzler A, Pollok B. Effects of 10 Hz and 20 Hz transcranial alternating current stimulation (tACS) on motor functions and motor cortical excitability. Behav Brain Res. 2013 Mar 15;241:1-6. doi: 10.1016/j.bbr.2012.11.038. Epub 2012 Dec 3.'}, {'pmid': '24291565', 'type': 'BACKGROUND', 'citation': 'Jausovec N, Jausovec K. Increasing working memory capacity with theta transcranial alternating current stimulation (tACS). Biol Psychol. 2014 Feb;96:42-7. doi: 10.1016/j.biopsycho.2013.11.006. Epub 2013 Nov 27.'}, {'pmid': '25981160', 'type': 'BACKGROUND', 'citation': 'Riecke L, Formisano E, Herrmann CS, Sack AT. 4-Hz Transcranial Alternating Current Stimulation Phase Modulates Hearing. Brain Stimul. 2015 Jul-Aug;8(4):777-83. doi: 10.1016/j.brs.2015.04.004. Epub 2015 Apr 24.'}, {'pmid': '25850008', 'type': 'BACKGROUND', 'citation': 'Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.'}, {'pmid': '19815630', 'type': 'RESULT', 'citation': 'Jefferson S, Mistry S, Singh S, Rothwell J, Hamdy S. Characterizing the application of transcranial direct current stimulation in human pharyngeal motor cortex. Am J Physiol Gastrointest Liver Physiol. 2009 Dec;297(6):G1035-40. doi: 10.1152/ajpgi.00294.2009. Epub 2009 Oct 8.'}, {'pmid': '22445135', 'type': 'RESULT', 'citation': 'Moliadze V, Atalay D, Antal A, Paulus W. Close to threshold transcranial electrical stimulation preferentially activates inhibitory networks before switching to excitation with higher intensities. Brain Stimul. 2012 Oct;5(4):505-11. doi: 10.1016/j.brs.2011.11.004. Epub 2012 Feb 22.'}, {'pmid': '20087360', 'type': 'RESULT', 'citation': 'Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.'}, {'pmid': '27881788', 'type': 'RESULT', 'citation': 'Moisa M, Polania R, Grueschow M, Ruff CC. Brain Network Mechanisms Underlying Motor Enhancement by Transcranial Entrainment of Gamma Oscillations. J Neurosci. 2016 Nov 23;36(47):12053-12065. doi: 10.1523/JNEUROSCI.2044-16.2016.'}, {'pmid': '22031888', 'type': 'RESULT', 'citation': 'Fertonani A, Pirulli C, Miniussi C. Random noise stimulation improves neuroplasticity in perceptual learning. J Neurosci. 2011 Oct 26;31(43):15416-23. doi: 10.1523/JNEUROSCI.2002-11.2011.'}, {'pmid': '27857687', 'type': 'RESULT', 'citation': 'Rjosk V, Kaminski E, Hoff M, Gundlach C, Villringer A, Sehm B, Ragert P. Transcranial Alternating Current Stimulation at Beta Frequency: Lack of Immediate Effects on Excitation and Interhemispheric Inhibition of the Human Motor Cortex. Front Hum Neurosci. 2016 Nov 3;10:560. doi: 10.3389/fnhum.2016.00560. eCollection 2016.'}, {'pmid': '19109497', 'type': 'RESULT', 'citation': 'Terney D, Chaieb L, Moliadze V, Antal A, Paulus W. Increasing human brain excitability by transcranial high-frequency random noise stimulation. J Neurosci. 2008 Dec 24;28(52):14147-55. doi: 10.1523/JNEUROSCI.4248-08.2008.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSwallowing 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.\n\nParticipants: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history\n\nExclusion Criteria:\n\n* a history of epilepsy\n* cardiac pacemaker\n* previous brain surgery\n* previous swallowing problems\n* risk of potential pregnancy\n* metal in the head or eyes\n* use of medication that acts on the central nervous system.'}, 'identificationModule': {'nctId': 'NCT04040803', 'briefTitle': 'tACS and tRNS Studies on Brain Control of Swallowing', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Characterizing the Application of Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation Over Human Pharyngeal Motor Cortex', 'orgStudyIdInfo': {'id': '2019-5932-10164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 Hz tACS', '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.\n\n10 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.', 'interventionNames': ['Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)']}, {'type': 'EXPERIMENTAL', 'label': '20 Hz tACS', '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.\n\n20 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.', 'interventionNames': ['Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)']}, {'type': 'EXPERIMENTAL', 'label': '70Hz tACS', '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.\n\n70 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.', 'interventionNames': ['Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)']}, {'type': 'EXPERIMENTAL', 'label': '0.1-640Hz tRNS', '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.\n\n0.1-640Hz tRNS will be performed over the pharyngeal cortex region and contralateral supraorbital region.', 'interventionNames': ['Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', '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).\n\nSham condition will be applied over pseudo-stimulation of pharyngeal cortex region and contralateral supraorbital region.', 'interventionNames': ['Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)']}], 'interventions': [{'name': 'Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['0.1-640Hz tRNS', '10 Hz tACS', '20 Hz tACS', '70Hz tACS', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6 8HD', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Upper G.I laboratory, Salford Royal Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Shaheen Hamdy, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GI-sciences, Salford Royal NHS Foundation Trust, University of Manchester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof Shaheen Hamdy PhD FRCP', 'investigatorAffiliation': 'University of Manchester'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-30', 'type': 'RELEASE'}, {'date': '2023-09-29', 'type': 'RESET'}, {'date': '2025-03-31', 'type': 'RELEASE'}, {'date': '2025-04-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Prof Shaheen Hamdy PhD FRCP, Principal Investigator, University of Manchester'}}}}