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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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • University hospital of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TRT and real tDCS

TRT and sham tDCS

Arm Description

Outcomes

Primary Outcome Measures

Tinnitus Functional Index (TFI)

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2014
Last Updated
April 14, 2016
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT02285803
Brief Title
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
Official Title
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
TRT and real tDCS
Arm Type
Active Comparator
Arm Title
TRT and sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Primary Outcome Measure Information:
Title
Tinnitus Functional Index (TFI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hyperacusis Questionnaire
Time Frame
3 months
Title
Hospital Anxiety and depression Scale
Time Frame
3 months
Title
Patient Global Impression of Change
Time Frame
3 months
Title
Psychoacoustic measurements
Time Frame
3 months
Title
Late Latency Evoked Potentials
Time Frame
3 months
Title
Visual Analogue Scale of Loudness
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Facility Information:
Facility Name
University hospital of Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26554670
Citation
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.
Results Reference
derived

Learn more about this trial

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

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