Clinical trial NCT01965028: Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus
Official title: Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: tinnitus
transcranial random noise stimulation
tRNS
auditory cortex
non-invasive brain stimulation
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.

Detailed description: Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* Diagnosis: Duration of tinnitus more than 6 months

Exclusion Criteria:

* Objective tinnitus
* Irregular head shap below the electrodes
* Eczema on the head
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse

Primary outcomes:
measure: Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
timeFrame: Week 12
Secondary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Questionnaire
timeFrame: Week 2
measure: Change of tinnitus severity as measured by the Tinnitus Questionnaire
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Questionnaire
timeFrame: Week 12
measure: Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
timeFrame: Week 2
measure: Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
timeFrame: Week 12
measure: Change of depressive symptoms as measured by the Major Depression Inventory
timeFrame: Week 2
measure: Change of depressive symptoms as measured by the Major Depression Inventory
timeFrame: Week 4
measure: Change of depressive symptoms as measured by the Major Depression Inventory
timeFrame: Week 12
measure: Change in quality of life as measured by the WHOQoL-Bref
timeFrame: Week 2
measure: Change in quality of life as measured by the WHOQoL-Bref
timeFrame: Week 4
measure: Change in quality of life as measured by the WHOQoL-Bref
timeFrame: Week 12
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg - Dept of Psychiatry
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreuzer PM, Poeppl TB, Rupprecht R, Vielsmeier V, Lehner A, Langguth B, Schecklmann M. Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study. Sci Rep. 2019 Aug 22;9(1):12274. doi: 10.1038/s41598-019-48686-0.