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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02285803
• Other study ID #: EC 14/40/406
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2014
• Last updated: November 4, 2014
• Start date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Antwerp
• Contact: Sarah Rabau
• Email: sarah.rabau[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee University Hospital of Antwerp
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: May 2015
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• transcranial direct current stimulation (tDCS)

Locations

Country	Name	City	State
Belgium	University hospital of Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Functional Index (TFI)		3 months
Primary	Visual Analogue Scale of Loudness		3 months
Secondary	Hyperacusis Questionnaire		3 months
Secondary	Hospital Anxiety and depression Scale		3 months
Secondary	Patient Global Impression of Change		3 months
Secondary	Psychoacoustic measurements		3 months
Secondary	Late Latency Evoked Potentials		3 months