Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383147
• Other study ID #: USZ-ORL-KT-001
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: October 30, 2017
• Start date: March 2015
• Est. completion date: August 24, 2017

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75

• Chronic Tinnitus > 0.5 years

• Informed Consent

• Fluent in German language

Exclusion Criteria:

• Psychological and neurological disorders other than tinnitus

• Drug- or Alcohol abuse

• Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake

• Impairing hearing loss or Cochlea Implant

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Device:
• Tomographic Neurofeedback
EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex and deliver feedback for the patient
• Non Tomographic Neurofeedback
EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Otorhinolaryngology ORL	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17. — View Citation

Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. Review. — View Citation

Hartmann T, Lorenz I, Müller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Tinnitus symptoms assessed by questionnaires	Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.	at 1, 3, 6 month follow up
Primary	Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex	EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods	at 1, 3, 6 month follow up
Secondary	Difference in efficacy between Tomographic Neurofeedback (TONF) and Non Tomographic Neurofeedback (NTE) in treatment of tinnitus assessed by tinnitus questionnaires and frequency band EEG-activity measurements (3-4Hz and 8-12Hz) compared to Baseline.	Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.	at 1, 3, 6 month follow up