Brief Summary

Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol. Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness). Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied. Based on this multifocal (Insula, dorsal anterior cingulate cortex \& auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

July 1, 2018

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed

Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

2.9 years

First QC Date

March 27, 2019

Last Update Submit

October 12, 2021

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (2)

Change from Baseline in Tinnitus symptoms assessed by questionnaires
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires
Time Frame: at 1, 3, 6 month follow up
Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
Time Frame: at 1, 3, 6 month follow up

Secondary Outcomes (1)

brain structure (volume, surface area) of the three regions of interest as predictor for training success.
Baseline (measurement before training)

Study Arms (6)

dACC,I,AC

ACTIVE COMPARATOR

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) \& the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions. 12 sessions of Neurofeedback Training, 1-2 times per week.