The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Nov 2014
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 18, 2016
April 1, 2016
1.3 years
October 31, 2014
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Tinnitus Functional Index (TFI)
3 months
Secondary Outcomes (6)
Hyperacusis Questionnaire
3 months
Hospital Anxiety and depression Scale
3 months
Patient Global Impression of Change
3 months
Psychoacoustic measurements
3 months
Late Latency Evoked Potentials
3 months
- +1 more secondary outcomes
Study Arms (2)
TRT and real tDCS
ACTIVE COMPARATORTRT and sham tDCS
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Duration of tinnitus \> 6 months
- Maximum loudness of tinnitus on the VAS ≥ 4
- TFI score ≥ 25
You may not qualify if:
- Pregnancy
- Psychiatric disorders
- Pace maker or defibrillator
- Pulsatile tinnitus
- Acoustic Neurinoma
- CVA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital of Antwerp
Edegem, Antwerp, 2650, Belgium
Related Publications (1)
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.
PMID: 26554670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 7, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 18, 2016
Record last verified: 2016-04