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MaST: MEG and Brain Stimulation in Tinnitus (MaST)

2022年9月7日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Nottinghamshire
      • Nottingham、Nottinghamshire、イギリス、NG1 5DU
        • University of Nottingham, NIHR Nottingham Biomedical Research Centre

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
偽コンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Oscillatory activity
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Blinding
時間枠:Within 5 minutes after intervention
Effectiveness of blinding using a questionnaire
Within 5 minutes after intervention
Adverse effects
時間枠:Within 5 minutes after intervention
Type and severity of adverse effects measured with adverse affects questionnaire
Within 5 minutes after intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Magdalena N Sereda, PhD、NIHR Nottingham BRC / University of Nottingham
  • スタディディレクター:Bas Labree, MSc、NIHR Nottingham BRC / University of Nottingham

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年12月7日

一次修了 (実際)

2022年5月31日

研究の完了 (実際)

2022年5月31日

試験登録日

最初に提出

2021年6月29日

QC基準を満たした最初の提出物

2021年7月15日

最初の投稿 (実際)

2021年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2022年9月8日

QC基準を満たした最後の更新が送信されました

2022年9月7日

最終確認日

2022年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 505-2003

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