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

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT02285803
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-31
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRT and real tDCS	transcranial direct current stimulation (tDCS)	-
TRT and sham tDCS	transcranial direct current stimulation (tDCS)	-

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index (TFI)	3 months

Secondary Outcome Measures

Name	Time	Method
Hyperacusis Questionnaire	3 months
Late Latency Evoked Potentials	3 months
Psychoacoustic measurements	3 months
Visual Analogue Scale of Loudness	3 months
Hospital Anxiety and depression Scale	3 months
Patient Global Impression of Change	3 months

Trial Locations

Locations (1)

University hospital of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium