None listed
Conditions
Brief summary
Tinnitus is conscious awareness of sound(s) perceived in the ear(s) and/or the head, occurring without an external, driving sound source and a common symptom of intense sound exposure, ear pathology or hearing loss. Most experience transitory tinnitus and find tinnitus manageable. One in 200 New Zealanders suffer chronic tinnitus and experience life disruption from disturbed: attentional focus, sleep and depression. Brain imaging studies assessing tinnitus have tried to rectify the lack of objective tinnitus measurements. Such studies found tinnitus was linked with regional cortical activation of auditory and non-auditory brain regions indicating networked systems: comprising attention, memory and emotional centres. Hearing-related neuroplastic changes in the auditory pathways and cortex are associated with ear pathology or intense sound exposure, yet findings from tinnitus-related imaging studies suggest brain networks contribute to tinnitus’ perceived severity and pathological sustainability. Recent research has sought to promote cortical plasticity to counteract and treat neuroplastic and network changes associated with tinnitus. Auditory perceptual training using a selective attention format, lead to significant improvements in tinnitus’ effect on daily life and attention. Sensory modality research e.g. vision, hearing and tactile, show modality-specific sensations are either reinforced (heightened) or conflicted with (sensation from one sensory domain is intensified at the expense of another), when paired. No drug therapy for tinnitus currently exists but evidence supports certain Selective Serotonin Reuptake Inhibitors (SSRIs) promote neuroplastic change. Aims: Couple physician-administered, low-dose fluoxetine with integrated, multi-sensory training (visual, auditory, tactile) to promote therapeutic cortical plasticity for treating tinnitus and objectively measure outcomes via resting-state Magnetic Resonance Imaging (MRI).
Interventions
Application of low-dose (20 mg) SSRI (Fluoxetine) via oral administration to promote cortical plasticity 1X/day for 20 days, in conjunction with multi-sensory integration perceptual training (visual, auditory & tactile) also for 20 days, as a novel form of tinnitus treatment. Participants will ingest one 20 mg Fluoxetine tablet daily in the morning and following, engage in the training. The multi-sensory perceptual training will be loaded to a loanable laptop. Following a one hour resting-sta
Application of low-dose (20 mg) SSRI (Fluoxetine) via oral administration to promote cortical plasticity 1X/day for 20 days, in conjunction with multi-sensory integration perceptual training (visual, auditory & tactile) also for 20 days, as a novel form of tinnitus treatment. Participants will ingest one 20 mg Fluoxetine tablet daily in the morning and following, engage in the training. The multi-sensory perceptual training will be loaded to a loanable laptop. Following a one hour resting-state MRI session (Centre for Advanced MRI CAMRI) to collect pre-training data and a one hour in-house (University of Auckland labs) session to also collect pre-training tinnitus, hearing and questionnaire-based data: depression, handedness and tinnitus impressions & history, and acclimatize participants to the operation of the laptop and training procedure; participants will engage in the training. They will transport the training to their home environment via the loaned and pre-programmed laptop. Participants will engage in the multi-sensory perceptual training for 30 minutes per day, every day, for 20 days at home. After 20 days, the perceptual training concludes and the participant returns the laptop and engages in post-training, resting-state MRI (CAMRI) and tinnitus & questionnaire assessments (University of Auckland labs).
Sponsors
The University of Auckland Research Faculty
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Outcome results
None listed