A randomised controlled trial on the efficacy of the selective serotonin re-uptake inhibitor Fluoxetine combined with a computerised multi-sensory training (visual, auditory, tactile) in the treatment of chronic tinnitus in adult sufferers.

Not Applicable

Completed

• Conditions: Ear - Other ear disorders; Chronic tinnitus in adult participants who are otherwise healthy

• Registration Number: ACTRN12613000213741
• Lead Sponsor: The University of Auckland Research Faculty

Brief Summary

Multisensory perceptual training resulted in neural connectivity changes consistent with the underlying task. Improvements in tinnitus measures were correlated with changes in sensory and attention networks.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-22
• Study Completion: 2014-09-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Chronic (> 6 months in duration) tinnitus, that is unilateral (lateralised to one side of the head more than the other), occurring in the adult population (age 18 or older). Less than a 70 dBHL hearing loss in the worse-affected ear for any 1 test frequency. Normal tactile sensitivity as per the Von Frey Monofilament screen. Able to see a computer monitor reliably via a vision check. No musculoskeletal contributors to tinnitus that are outside of scope of a spinal-manual therapist's (a registered chiropractor) treatment practise. No precluding factors to administration of SSRI (Fluoxetine) or resting-state MRI, as indicated by questionnaire and review by specialists in the field of pharmacology and MRI.

Exclusion Criteria

1) Hearing loss in the worse-affected ear for any 1 test frequency that is 70 dBHL or greater.
2) Inability to reliably see a computer monitor as per a field-check of vision.
3) Atypical or abnormal tactile sensitivity as indicated by the Von Frey Monofiliment screen.
4) Musculoskeletal contributors to tinnitus that are outside of scope of a spinal-manual therapist's (a registered chiropractor) treatment practise.
5) Precluding factors to administration of low-dose SSRI (Fluoxetine) as indicated by questionnaire and review by specialists in the field of pharmacology.
6) Precluding factors to administration of resting-state MRI as indicated by questionnaire and review by specialists in the field of MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome 1: The primary outcome measure will be the Tinnitus Functional Index TFI). A decrease of 13 TFI points or greater, will be indicative of treatment effectiveness. <br>[Primary Time point: Baseline, 1 week prior to perceptual training (20 days), immediately post-perceptual training and 3 week's after training cessation (washout).]

Secondary Outcome Measures

Name	Time	Method
Mean Tinnitus Severity Scale score. [Primary Time point: Baseline, 1 week prior to perceptual training (20 days), immediately post-perceptual training and 3 week's after training cessation (washout).];Secondary outcome 2: A reduction in the Tinnitus Handicap Inventory (THI) of 6 points or greater, will be indicative of treatment effectiveness. [Primary Time point: Baseline, 1 week prior to perceptual training (20 days), immediately post-perceptual training and 3 week's after training cessation (washout).]