|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 April 2016 |
|
Main ID: |
NCT02285803 |
|
Date of registration:
|
31/10/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
|
|
Scientific title:
|
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
|
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02285803 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tinnitus
|
|
Intervention(s)
|
|
Device: transcranial direct current stimulation (tDCS)
|
|
Primary Outcome(s)
|
|
Tinnitus Functional Index (TFI)
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Hospital Anxiety and depression Scale
[Time Frame: 3 months]
|
|
Visual Analogue Scale of Loudness
[Time Frame: 3 months]
|
|
Psychoacoustic measurements
[Time Frame: 3 months]
|
|
Patient Global Impression of Change
[Time Frame: 3 months]
|
|
Hyperacusis Questionnaire
[Time Frame: 3 months]
|
|
Late Latency Evoked Potentials
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
EC 14/40/406
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|