None listed
Conditions
Brief summary
This study aims to explore high definition transcranial infraslow pink noise stimulation (HD-tIPNS) targeting three brain regions involved in the generation and maintenance of tinnitus [the auditory cortex (AC), posterior cingulate cortex (PCC) and parahippocampus (PHC)]. This study also aims to evaluate the feasibility and safety of this HD-tIPNS protocol on participants. We hypothesise HD-tIPNS will influence the activity and functional connectivity in resting state brain networks compared to sham stimulation, particularly in targeted brain regions. We also hypothesise these changes in activity and functional connectivity will be correlated with improvement in clinical outcomes and HD-tIPNS will demonstrate a positive trend of effect on loudness and distress in individuals with chronic tinnitus.
Interventions
high definition transcranial infraslow pink noise stimulation (HD-tIPNS) will be administered by a researcher experienced in administering neuromodulation techniques. HD-tIPNS will be administered face-to-face, three times a week for four weeks (i.e. total of 12 intervention sessions) in the Department of surgical sciences laboratory at the Dunedin School of Medicine, University of Otago. Each intervention session will have a duration of ~1hr (30min set-up and 30min of stimulation). For the acti
high definition transcranial infraslow pink noise stimulation (HD-tIPNS) will be administered by a researcher experienced in administering neuromodulation techniques. HD-tIPNS will be administered face-to-face, three times a week for four weeks (i.e. total of 12 intervention sessions) in the Department of surgical sciences laboratory at the Dunedin School of Medicine, University of Otago. Each intervention session will have a duration of ~1hr (30min set-up and 30min of stimulation). For the active treatment group (HD-tIPNS), the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The pink noise stimulation at a current strength of maximum of 0.6mA will be superimposed on the infraslow stimulation waveform of a current intensity of 1mA, such that the current strength of the waveform never exceeds the maximum of 2mA. For the sham stimulation group, to create an identical skin sensation to the active stimulation, the current will be applied for a 60s ramp up (0-2mA) and 60s ramp down (2-0mA), at the beginning and the end of each stimulation session, without any current for the remainder of the stimulation period. A battery-driven wireless 32 channel transcranial current stimulation (Starstim32 TES®, Neuroelectrics, Spain, http://www.neuroelectrics.com) will be used to deliver stimulation while the participants are comfortably and quietly seated. The Starstim32 is a high definition system with small electrode size (1 cm radius) that can focally target deeper brain regions. Thirty-two circular Ag/AgCl stimulation electrodes will be placed on a neoprene head cap following the International 10-20 EEG system to target the AC, PCC, and PHC. The optimal montages to target the network activity of these areas were created using the Stimweaver optimization software by the Neuroelectrics company. The placement of the electrodes will be identical for both the intervention groups. Using the Neuroelectrics software, intervention protocols will be administered to participants without the researcher being aware of the specific intervention group the participant has been randomly allocated to. Adherence to the intervention will be monitored by recording the number of sessions attended by each participant and will be represented as a percentage of the total number of sessions.
Sponsors
University of Otago Research office
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Capable of understanding and signing an informed consent form A diagnosis of chronic tinnitus At Screening, have constant subjective tinnitus with a grade of 3-4 on the mTQ and a TFI score of 25 or greater (indicating moderate/severe presentation with significant problems associated with tinnitus)
Exclusion criteria
• Metal or electronic implants in the head and neck region, and presence of any pacemaker or defibrillator • Neurological conditions • Previous brain surgery • Active inner/middle/external ear pathology identified by diagnostic audiological exam. • Cognitive or psychiatric disorders • Recent or current pregnancy • History of epilepsy, seizures, or substance abuse • Hyperacusis • Received treatment for their tinnitus within two months of this study (including undergoing any therapy e.g. sound therapy) • Dyslipidaemia • History of uncontrolled/untreated hypertension • Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved). • Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk. • Participants will be permitted to continue their medications for the duration of the trial, with the type and dosage of medication being recorded throughout the duration of the trial. However, participants with the intention of taking new medications in the next 2 months, will be excluded.
Outcome results
None listed