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ICCAC-ToNF & Tinnitus

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Tinnitus, Subjective

Treatments

Other: tomographic EEG Neurofeedback Training

Study type

Interventional

Funder types

Other

Identifiers

NCT03895047
2018-01035

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • chronic tinnitus (>6 months)
  • Age 40 to 80
  • Informed Consent
  • Fluent in German language
  • mentally & physically fit

Exclusion criteria

  • ferromagnetic implants
  • cochlear implants
  • average hearing loss over 50 dB
  • claustrophoby
  • addiction to alcohol or drugs
  • intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
  • acute suicidal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 6 patient groups

dACC,I,AC
Active Comparator group
Description:
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.
Treatment:
Other: tomographic EEG Neurofeedback Training
dACC,AC,I
Active Comparator group
Description:
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.12 sessions of Neurofeedback Training, 1-2 times per week.
Treatment:
Other: tomographic EEG Neurofeedback Training
I,dACC,AC
Active Comparator group
Description:
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.
Treatment:
Other: tomographic EEG Neurofeedback Training
I,AC,dACC
Active Comparator group
Description:
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.
Treatment:
Other: tomographic EEG Neurofeedback Training
AC,dACC,I
Active Comparator group
Description:
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.
Treatment:
Other: tomographic EEG Neurofeedback Training
AC,I,dACC
Active Comparator group
Description:
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.
Treatment:
Other: tomographic EEG Neurofeedback Training

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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