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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02285803
Enrollment
Unknown
Registered
2014-11-07
Start date
2014-11-30
Completion date
2016-03-31
Last updated
2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief summary

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.

Interventions

DEVICEtranscranial direct current stimulation (tDCS)

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Tinnitus Functional Index (TFI)3 months

Secondary

MeasureTime frame
Hospital Anxiety and depression Scale3 months
Patient Global Impression of Change3 months
Hyperacusis Questionnaire3 months
Late Latency Evoked Potentials3 months
Visual Analogue Scale of Loudness3 months
Psychoacoustic measurements3 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026