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Trial registered on ANZCTR


Registration number
ACTRN12621001470886
Ethics application status
Approved
Date submitted
27/09/2021
Date registered
27/10/2021
Date last updated
27/10/2021
Date data sharing statement initially provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain activity changes following a single session of Non-invasive Electrical Stimulation in participants with Chronic Tinnitus
Scientific title
The Electrophysiological Effects of a single session of Transcranial Infraslow nested Pink Noise stimulation in participants with Chronic Tinnitus.
Secondary ID [1] 305417 0
None
Universal Trial Number (UTN)
U1111-1269-8303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Subjective Tinnitus 323785 0
Condition category
Condition code
Neurological 321298 321298 0 0
Other neurological disorders
Ear 321299 321299 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321821 0
Treatment: Devices
Comparator / control treatment
Participants assigned to control/sham will receive actisham (Neuroelectrics, Spain, http://www.neuroelectrics.com) stimulation. Actisham is designed to create an indistinguishable sensation (in terms of character and location) from active stimulation but with limited current flow to the brain. Actisham will be delivered for a 60 Second ramp up (0-2mA), and 60 Second ramp down (2-0mA) for a total of 2 minutes at the beginning and 2 minutes at the end of each session, with no current applied for 26 minutes in between these periods.
Control group
Placebo

Outcomes
Primary outcome [1] 329080 0
Change in resting state EEG Activity, as assessed by eLORETA (Low Resolution Electromagnetic Tomography) at targeted regions of stimulation. These Regions of Interest for activity analysis are the Auditory Cortex, Parahippocampus, and Posterior Cingulate Cortex- all bilaterally. Additionally non-Region of interest based Whole Brain Analysis for activity changes will be undertaken, with robust corrections for multiple comparisions
Timepoint [1] 329080 0
At baseline and Directly after stimulation session. (comparing 10 minute, 32 Channel 10-20 system EEGs collected via Starstim device directly before and after the stimulation session).
Primary outcome [2] 329081 0
Change in resting state EEG functional connectivity, as assessed by eLORETA (Low Resolution Electromagnetic Tomography) at targeted regions of stimulation. These Regions of Interest for functional connectivity analysis are the Auditory Cortex, Parahippocampus, and Posterior Cingulate Cortex- all bilaterally.
Timepoint [2] 329081 0
At baseline and Directly after stimulation session. (comparing 10 minute, 32 Channel 10-20 system EEGs collected via Starstim device directly before and after the stimulation session).
Secondary outcome [1] 401385 0
Any adverse events, Will be measured by a case report form detailing a verbatim description of the event, intensity of each symptom using a likert scale ranging from 0 (none) to 10 (extreme), relation of the symptom to the treatment using a scale ranging from 1 (unrelated) to 5 (strongly related), duration of each symptom and time taken for each symptom to resolve (expressed in min), and any drop-outs due to adverse effects.
Timepoint [1] 401385 0
Immediately post-intervention and 1 day post-intervention
Secondary outcome [2] 401386 0
Numeric Rating Scale (0-10) for tinnitus loudness.
Timepoint [2] 401386 0
Baseline and post-intervention (1 day post-treatment)
Secondary outcome [3] 402336 0
Numeric Rating Scale (0-10) for tinnitus distress.
Timepoint [3] 402336 0
Baseline and post-intervention (1 day post-treatment)
Secondary outcome [4] 402337 0
Numeric Rating Scale (0-10) for tinnitus annoyance.
Timepoint [4] 402337 0
Baseline and post-intervention (1 day post-treatment)
Secondary outcome [5] 402338 0
Numeric Rating Scale (0-10) for tinnitus constancy.
Timepoint [5] 402338 0
Baseline and post-intervention (1 day post-treatment)
Secondary outcome [6] 402339 0
Numeric Rating Scale (0-10) for tinnitus interference.
Timepoint [6] 402339 0
Baseline and post-intervention (1 day post-treatment)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
15/12/2021
Actual
Date of last data collection
Anticipated
16/12/2021
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 24150 0
New Zealand
State/province [1] 24150 0

Funding & Sponsors
Funding source category [1] 309777 0
University
Name [1] 309777 0
University of Otago
Country [1] 309777 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO BOX 56
University of Otago
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 310808 0
None
Name [1] 310808 0
Address [1] 310808 0
Country [1] 310808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309530 0
Central Health and Disability Ethics Committe
Ethics committee address [1] 309530 0
Ethics committee country [1] 309530 0
New Zealand
Date submitted for ethics approval [1] 309530 0
Approval date [1] 309530 0
17/02/2021
Ethics approval number [1] 309530 0

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

Contacts
Principal investigator
Name 114474 0
Prof Dirk de Ridder
Address 114474 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114474 0
New Zealand
Phone 114474 0
+64 03 470 9337
Fax 114474 0
Email 114474 0
dirk.deridder@otago.ac.nz
Contact person for public queries
Name 114475 0
Dirk de Ridder
Address 114475 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114475 0
New Zealand
Phone 114475 0
+64 03 470 9337
Fax 114475 0
Email 114475 0
dirk.deridder@otago.ac.nz
Contact person for scientific queries
Name 114476 0
Dirk de Ridder
Address 114476 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114476 0
New Zealand
Phone 114476 0
+64 03 470 9337
Fax 114476 0
Email 114476 0
dirk.deridder@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.