MaST: MEG and Brain Stimulation in Tinnitus

NCT04978142 | Completed DMC

• 1 other identifier: 505-2003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (3)

• Oscillatory activity

  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

  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

  Loudness of tinnitus percept as measured by visual analogue scale (0-10) with a higher score meaning louder tinnitus

  Within 5 minutes after intervention

Secondary Outcomes (2)

• Blinding

  Within 5 minutes after intervention

• Adverse effects

  Within 5 minutes after intervention

Study Arms (2)

Active

EXPERIMENTAL

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).

Device: transcranial Direct Current Stimulation (tDCS)

Sham

SHAM COMPARATOR

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.

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Active; Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over
• Have subjective tinnitus
• Able to read and understand English
• Safe to undergo tDCS (according to tDCS Safety Questionnaire)
• Safe to undergo MRI scanning (according to MRI Safety Screening Questionnaire)

You may not qualify if:

• Aged under 18 years
• No tinnitus
• Not able to read and understand English
• Not safe to undergo tDCS (according to tDCS Safety Questionnaire)
• Not safe to undergo MRI scanning (according to MRI Safety Screening Questionnaire)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham, NIHR Nottingham Biomedical Research Centre

Nottingham, Nottinghamshire, NG1 5DU, United Kingdom

Location

Related Publications (6)

• Adjamian P, Sereda M, Hall DA. The mechanisms of tinnitus: perspectives from human functional neuroimaging. Hear Res. 2009 Jul;253(1-2):15-31. doi: 10.1016/j.heares.2009.04.001. Epub 2009 Apr 11.

  PMID: 19364527 BACKGROUND

• Adjamian P, Sereda M, Zobay O, Hall DA, Palmer AR. Neuromagnetic indicators of tinnitus and tinnitus masking in patients with and without hearing loss. J Assoc Res Otolaryngol. 2012 Oct;13(5):715-31. doi: 10.1007/s10162-012-0340-5. Epub 2012 Jul 12.

  PMID: 22791191 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Genitsaridi E, Partyka M, Gallus S, Lopez-Escamez JA, Schecklmann M, Mielczarek M, Trpchevska N, Santacruz JL, Schoisswohl S, Riha C, Lourenco M, Biswas R, Liyanage N, Cederroth CR, Perez-Carpena P, Devos J, Fuller T, Edvall NK, Hellberg MP, D'Antonio A, Gerevini S, Sereda M, Rein A, Kypraios T, Hoare DJ, Londero A, Pryss R, Schlee W, Hall DA. Standardised profiling for tinnitus research: The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ). Hear Res. 2019 Jun;377:353-359. doi: 10.1016/j.heares.2019.02.017. Epub 2019 Mar 2.

  PMID: 30871820 BACKGROUND

• Faber M, Vanneste S, Fregni F, De Ridder D. Top down prefrontal affective modulation of tinnitus with multiple sessions of tDCS of dorsolateral prefrontal cortex. Brain Stimul. 2012 Oct;5(4):492-8. doi: 10.1016/j.brs.2011.09.003. Epub 2011 Oct 5.

  PMID: 22019079 BACKGROUND

• Yadollahpour A, Mayo M, Saki N, Rashidi S, Bayat A. A chronic protocol of bilateral transcranial direct current stimulation over auditory cortex for tinnitus treatment: Dataset from a double-blinded randomized controlled trial. F1000Res. 2018 Jun 12;7:733. doi: 10.12688/f1000research.14971.1. eCollection 2018.

  PMID: 30356442 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Magdalena N Sereda, PhD

  NIHR Nottingham BRC / University of Nottingham

  PRINCIPAL INVESTIGATOR

• Bas Labree, MSc

  NIHR Nottingham BRC / University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 27, 2021
• Study Start: December 7, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)