- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04978142
MaST: MEG and Brain Stimulation in Tinnitus (MaST)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, Reino Unido, NG1 5DU
- University of Nottingham, NIHR Nottingham Biomedical Research Centre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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.
|
Comparador falso: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Oscillatory activity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Blinding
Periodo de tiempo: Within 5 minutes after intervention
|
Effectiveness of blinding using a questionnaire
|
Within 5 minutes after intervention
|
Adverse effects
Periodo de tiempo: Within 5 minutes after intervention
|
Type and severity of adverse effects measured with adverse affects questionnaire
|
Within 5 minutes after intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Magdalena N Sereda, PhD, NIHR Nottingham BRC / University of Nottingham
- Director de estudio: Bas Labree, MSc, NIHR Nottingham BRC / University of Nottingham
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 505-2003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tinnitus
-
State University of New York at BuffaloUniversity at BuffaloTerminadoTinnitus Subjetivo | Tinnitus | Tinnitus inducido por ruido | Tinnitus, Objetivo | Tinnitus agravado | Tinnitus pulsátil | Tinnitus, Emisión Oto-Acústica Espontánea | Tinnitus, hacer clic | Tinnitus, tensor del tímpano inducidoEstados Unidos
-
Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoAlemania, Portugal, España, Reino Unido, Austria
-
Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoEstados Unidos, Reino Unido, Polonia, Austria, Bélgica, Brasil, República Checa, Francia, Alemania, México, Países Bajos, Portugal, Sudáfrica, España
-
Merz Pharmaceuticals GmbHTerminadoTinnitus SubjetivoBélgica, República Checa, Francia, Polonia, Sudáfrica, Países Bajos
-
Mohab MohammedAún no reclutandoTinnitus pulsátil (diagnóstico)
-
Technical University of DenmarkTerminado
-
Otonomy, Inc.TerminadoTinnitus SubjetivoEstados Unidos, Reino Unido, Alemania, Polonia
-
Cairo UniversityTerminado
-
Medical University of LodzTerminado
Ensayos clínicos sobre transcranial Direct Current Stimulation (tDCS)
-
Minneapolis Veterans Affairs Medical CenterCenter for Veterans Research and EducationTerminadoObesidad | Impulsividad | Comer en exceso compulsivamenteEstados Unidos
-
University of ArkansasReclutamientoAfasiaEstados Unidos
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)TerminadoAnhedonia | Trastorno depresivo mayorEstados Unidos
-
Kaohsiung Medical University Chung-Ho Memorial...Terminado