Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000277842
Ethics application status
Approved
Date submitted
7/03/2012
Date registered
8/03/2012
Date last updated
26/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of non-invasive brain stimulation and hearing aids to reduce tinnitus
Scientific title
Use of transcranial direct current stimulation and extended high frequency amplification to reduce tinnitus symptoms, measured with the Tinnitus Functional Index.
Secondary ID [1] 280033 0
Nil
Universal Trial Number (UTN)
U1111-1128-5379
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 285949 0
Hearing loss 285950 0
Condition category
Condition code
Ear 286137 286137 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-invasive brain stimulation will be offered for 5 sessions each lasting for 20 minutes on 5 consecutive days and digital hearing aids will be fitted after the 5th stimulation session.Participants will be followed up for 6 months.

Non invasive brain stimulation (tDCS) involves delivering a low-intensity current with two damp sponge electrodes placed on scalp. One electrode will be positioned over the auditory area on one side of brain. The other one will be placed on the forehead. participants will experience a slight tingling sensation under the electrodes for up to 2 minutes, after which the sensation diminishes and may become imperceptible. There is no need to shave head and the area under the electrode on forehead will be cleaned using an alcohol wipe. Participants will be asked to sit quietly during the period of stimulation. If they feel uncomfortable at any time during the stimulation, will be asked to notify the experimenter immediately.

Digital hearing aids will be given to participants for long term use (even after 6 months). They will not be taken back.
Intervention code [1] 284358 0
Treatment: Devices
Intervention code [2] 284359 0
Treatment: Other
Comparator / control treatment
Sham tDCS (non invasive brain stimulation) will be delivered through the NeuroConn stimulator (by choosing study mode and putting the special codes for sham stimulation, there will be 8 second initial ramp up and down time, however no stimulation will be delevered between these ramp up and ramp down thought the equipment)

Digital hearing aids will be provided to control group participants as well
Control group
Placebo

Outcomes
Primary outcome [1] 286609 0
Tinnitus Functional Index
Timepoint [1] 286609 0
After 6 months of hearing aid use post non-invasive brain stimulation.
Secondary outcome [1] 296265 0
Tinnitus handicap questionnaire
Timepoint [1] 296265 0
After 6 months of hearing aid use post non-invasive brain stimulation.
Secondary outcome [2] 296266 0
Hospital Anxiety and Depression Scale
Timepoint [2] 296266 0
After 6 months of hearing aid use post non-invasive brain stimulation.
Secondary outcome [3] 296267 0
Tinnitus severity Numeric scale
Timepoint [3] 296267 0
After 6 months of hearing aid use post non-invasive brain stimulation.
Secondary outcome [4] 296391 0
Hearing Handicap Inventory
Timepoint [4] 296391 0
After 6 months of hearing aid use post non-invasive brain stimulation.

Eligibility
Key inclusion criteria
Chronic tinnitus for a minimum of 18 months

binaural aidable hearing loss

Minimum score of 25 on Tinnitus Functional Index
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication on neurological checklist for administering tDCS (non invasive brain stimulation) such as previous brain surgeries, epilepsy, family history of epilepsy, metal implants in body or head, pregnancy etc.

Hearing aid users

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation by central randomisation by computer. Method used to create the random order for allocation of subjects in different groups was stratified allocation based on the following factors (Age, Gender, TFI score, Tinnitus duration and severity)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4175 0
New Zealand
State/province [1] 4175 0
Auckland

Funding & Sponsors
Funding source category [1] 284790 0
Charities/Societies/Foundations
Name [1] 284790 0
Neurological foundation of New Zealand
Country [1] 284790 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Neurological foundation of NZ
Address
66 Grafton Road, Grafton
PO Box 110022, Auckland Hospital
Auckland 1148
Country
New Zealand
Secondary sponsor category [1] 283675 0
Commercial sector/Industry
Name [1] 283675 0
GN Resound hearing aid company
Address [1] 283675 0
4200 West Bryn Mawr Avenue,Chicago, IL-60646
Country [1] 283675 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286780 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 286780 0
Ethics committee country [1] 286780 0
New Zealand
Date submitted for ethics approval [1] 286780 0
Approval date [1] 286780 0
07/06/2011
Ethics approval number [1] 286780 0
2011/211

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33838 0
Address 33838 0
Country 33838 0
Phone 33838 0
Fax 33838 0
Email 33838 0
Contact person for public queries
Name 17085 0
GIRIRAJ SINGH SHEKHAWAT
Address 17085 0
Section of Audiology, Tamaki Innovation Campus
Private Bag 92019, Auckland-1142
Country 17085 0
New Zealand
Phone 17085 0
+642102861426
Fax 17085 0
+64093737624
Email 17085 0
[email protected]
Contact person for scientific queries
Name 8013 0
GRANT D SEARCHFIELD
Address 8013 0
Section of Audiology, Tamaki Innovation Campus
Private Bag 92019, Auckland-1142
Country 8013 0
New Zealand
Phone 8013 0
+649236316
Fax 8013 0
+64093737624
Email 8013 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.