The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients

NCT ID: NCT02285803

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

Brief Summary

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The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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TRT and real tDCS

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

TRT and sham tDCS

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Duration of tinnitus \> 6 months
* Maximum loudness of tinnitus on the VAS ≥ 4
* TFI score ≥ 25

Exclusion Criteria

* Pregnancy
* Psychiatric disorders
* Pace maker or defibrillator
* Pulsatile tinnitus
* Acoustic Neurinoma
* CVA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZA

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2.

Reference Type DERIVED
PMID: 26554670 (View on PubMed)

Other Identifiers

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EC 14/40/406

Identifier Type: -

Identifier Source: org_study_id

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