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MaST: MEG and Brain Stimulation in Tinnitus (MaST)

7 september 2022 bijgewerkt door: Magdalena Sereda, University of Nottingham

Transcranial Modulation of Oscillatory Brain Activity in People With Tinnitus: A Concurrent Transcranial Direct Current Stimulation (tDCS) - Magnetoencephalography (MEG) Study

Tinnitus is the awareness of a sound in the ear or head without any outside source. It affects around 15% of people in the UK. About 20% of people with tinnitus experience symptoms that negatively affect their quality of life including sleep disturbances, difficulties with hearing and concentration, social isolation, anxiety, depression, irritation or stress. Most common clinical management strategies for tinnitus include education and advice combined with some form of sound therapy. The effects of these management options are, however, variable. Currently, the exact aetiology of tinnitus is unknown although maladaptive plasticity due to sensorineural hearing loss is thought to play a big role. Neuroimaging studies have pointed to over-activation or excessive spontaneous activity within the central auditory cortex. Furthermore, electrophysiological techniques have confirmed the frontal cortex's role in tinnitus through dysfunctional top-down modulation.

Transcranial direct current stimulation (tDCS) is a neurostimulation technique in which weak currents (1-2 mA's) are delivered to the brain, thereby depolarising or hyperpolarising neurons within the desired region of cortex. tDCS is a non-invasive and easy to apply tool, delivered by applying two surface electrode to a patients head. It has previously been used as a treatment for depression, stroke rehabilitation, and cognitive enhancement.

Some studies have indicated potential benefit of tDCS in tinnitus patients, but this has not yet been investigated within the UK. Neuromodulation therapies should deliver a permanent reduction in tinnitus percept by driving the neuroplastic changes necessary to interrupt abnormal levels of oscillatory cortical activity and restore typical levels of activity. This change in activity should alter or interrupt the tinnitus percept (reduce or extinguish) and this should be concomitant with a change in the level of self-reported tinnitus handicap. The currently ongoing Cochrane review of neuromodulation (desynchronisation) for tinnitus in adults found mixed evidence for the electrical stimulation therapies for tinnitus, including tDCS. However, the review also found that the most recent tDCS trials that have used greater numbers of treatment sessions found significant reductions in tinnitus symptom severity, anxiety, and depression. Authors concluded that these findings warrant further trials of tDCS. Research studies using electroencephalography (EEG) or magnetoencephalography (MEG) suggested changes in oscillatory activity in different frequency bands that might be associated with tinnitus, however a consistent picture has not yet emerged. Reduction of this abnormal activity might signify a reduction in the level or perceived severity of TI and could potentially be used as a valuable indicator of the course of TI treatment.

In this project specific changes in brain activity that happen during a new treatment approach for tinnitus - transcranial Direct Current Stimulation (tDCS)- will be investigated. This will help to determine how the treatment might work, whether specific brain activity may be a meaningful biological indicator or objective measure of tinnitus, and provide a reliable measure of treatment-related change; this has not yet been achieved in tinnitus research but is crucial.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

Data collection session will involve the participant completing the Tinnitus Functional Index (TFI) and Demographics and Tinnitus History Questionnaire (D&THQ), which will provide the investigators with information about their personal tinnitus history including subjective characteristics such as loudness. The D&THQ consists of questions selected from the European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ). Participants will undergo a standard hearing test, which will inform the investigators of any hearing loss. The participant's head shape will be digitized to aid in the spatial localization of the MEG signal. The participant will then undergo 40 minutes of MEG scanning (10 minutes of resting state without tDCS, 20 minutes of resting state MEG with either active or sham tDCS, and then another 10 minutes of resting state MEG without tDCS. The first 10 minutes will serve as a baseline of resting state oscillatory brain activity. The concurrent tDCS and MEG recording will allow the investigators to observe changes in oscillatory brain activity during tDCS. The last 10 minutes of MEG recording will allow the investigators to see whether any changes in oscillatory activity persist after the stimulation ends. After the MEG recording has finished, the participant will undergo an anatomical MRI scan. This will allow the investigators to take the participants' individual brain morphology into account when analysing the source of the MEG signal.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Nottinghamshire
      • Nottingham, Nottinghamshire, Verenigd Koninkrijk, NG1 5DU
        • University of Nottingham, NIHR Nottingham Biomedical Research Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Aged 18 years or over
  2. Have subjective tinnitus
  3. Able to read and understand English
  4. Safe to undergo tDCS (according to tDCS Safety Questionnaire)
  5. Safe to undergo MRI scanning (according to MRI Safety Screening Questionnaire)

Exclusion Criteria:

  1. Aged under 18 years
  2. No tinnitus
  3. Not able to read and understand English
  4. Not safe to undergo tDCS (according to tDCS Safety Questionnaire)
  5. Not safe to undergo MRI scanning (according to MRI Safety Screening Questionnaire)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active
Active tDCS stimulation at 2 mA for 20 minutes, with a 10 seconds of ramp-up and 10 seconds of ramp-down time as used in previous tinnitus studies. The stimulation will be delivered via two rubber electrodes attached using a layer of conductive paste (35 cm2). The anode will be placed over the right dlPFC and cathode over the left dlPFC).
Non-invasive neuromodulation employing a direct current, applied using a DC STIMULATOR PLUS manufactured by NeuroConn Technology by NeuroCare. This is a micro-processor-controlled constant current source. It meets the highest safety standards thanks to (hardware- and software-based) multistage monitoring of the current path. By continuously monitoring electrode impedance it can detect insufficient contact with the skin and automatically terminate stimulation. This is a reliable method of avoiding any injury to the patient.
Sham-vergelijker: Sham
Placebo stimulation is performed using the same current intensity, but only applied for 45 seconds in addition to the 10 second ramp-up and 10 second ramp-down periods. The electrode configuration and placement will be identical to the active stimulation.
Non-invasive neuromodulation employing a direct current, applied using a DC STIMULATOR PLUS manufactured by NeuroConn Technology by NeuroCare. This is a micro-processor-controlled constant current source. It meets the highest safety standards thanks to (hardware- and software-based) multistage monitoring of the current path. By continuously monitoring electrode impedance it can detect insufficient contact with the skin and automatically terminate stimulation. This is a reliable method of avoiding any injury to the patient.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Oscillatory activity
Tijdsspanne: Continuously for 10 minutes before the onset of the intervention, continuously for 20 minutes before the intervention, continuously for 10 minutes after the intervention
Change in oscillatory resting state activity as measured with magnetoencephalography (MEG)
Continuously for 10 minutes before the onset of the intervention, continuously for 20 minutes before the intervention, continuously for 10 minutes after the intervention
Connectivity
Tijdsspanne: Continuously for 10 minutes before the onset of the intervention, continuously for 20 minutes before the intervention, continuously for 10 minutes after the intervention
Change in functional neural connectivity as measured with magnetoencephalography (MEG)
Continuously for 10 minutes before the onset of the intervention, continuously for 20 minutes before the intervention, continuously for 10 minutes after the intervention
Tinnitus loudness
Tijdsspanne: Within 5 minutes after intervention
Loudness of tinnitus percept as measured by visual analogue scale (0-10) with a higher score meaning louder tinnitus
Within 5 minutes after intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blinding
Tijdsspanne: Within 5 minutes after intervention
Effectiveness of blinding using a questionnaire
Within 5 minutes after intervention
Adverse effects
Tijdsspanne: Within 5 minutes after intervention
Type and severity of adverse effects measured with adverse affects questionnaire
Within 5 minutes after intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Magdalena N Sereda, PhD, NIHR Nottingham BRC / University of Nottingham
  • Studie directeur: Bas Labree, MSc, NIHR Nottingham BRC / University of Nottingham

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 december 2020

Primaire voltooiing (Werkelijk)

31 mei 2022

Studie voltooiing (Werkelijk)

31 mei 2022

Studieregistratiedata

Eerst ingediend

29 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2021

Eerst geplaatst (Werkelijk)

27 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2022

Laatste update ingediend die voldeed aan QC-criteria

7 september 2022

Laatst geverifieerd

1 september 2022

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 505-2003

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Tinnitus

Klinische onderzoeken op transcranial Direct Current Stimulation (tDCS)

3
Abonneren