None listed
Conditions
Brief summary
Resting-state cortical activity alterations have been demonstrated in individuals with tinnitus. Recent evidence suggests that alterations in the functional connectivity patterns between the Auditory cortex, Parahippocampus, and Posterior Cingulate cortex (AC, PHC, PCC) maintain tinnitus and are associated with its clinical and psychological outcomes. This study will explore the effect of the high-definition transcranial infraslow pink noise stimulation technique on the current density and functional connectivity of the AC, PHC, PCC.
Interventions
A single session of High definition, transcranial, infraslow, pink noise electrical stimulation (HD-tIPNS) will be administered by a researcher experienced in administering neuromodulation techniques. Stimulation will be delivered at 2mA of current for 30 minutes, with 60 seconds of ramping up (0-2mA) and down (2-0mA) at the beginning and end of each session.
A battery-driven wireless 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain, http://www.neuroelectrics.c
A single session of High definition, transcranial, infraslow, pink noise electrical stimulation (HD-tIPNS) will be administered by a researcher experienced in administering neuromodulation techniques. Stimulation will be delivered at 2mA of current for 30 minutes, with 60 seconds of ramping up (0-2mA) and down (2-0mA) at the beginning and end of each session. A battery-driven wireless 32 channel transcranial current stimulator (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 Auditory cortex, Posterior Cingulate cortex, and Parahippocampus (AC, PCC, and PHC) (All Bilaterally). 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 and sham groups.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
-Are aged between 18-70 years. -Are fluent in speaking and reading the predominantly used or recognized language of the study site. -Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming unreachable. -Must agree to inform the investigators within 48 hours of any medical conditions and procedures. -Comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain ~2 hours at the study site for each Experimental Session and be driven home after, and commit to medication dosing, and study procedures. -At Screening, Have Constant Subjective tinnitus.
Exclusion criteria
-Having any active inner/middle/external ear pathology, identified by diagnostic audiological exam. -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). -Participants with a prior history of seizures; susceptibility to photosensitivity; or a history of allergic skin reactions -Presence of any implant in head/neck -Presence of any pacemaker or defibrillator
Outcome results
None listed