Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-13 @ 11:27 PM
Study NCT ID:
NCT01965028
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus
Sponsor:
University of Regensburg
Organization:
Study Overview
Official Title:
Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tRNS-tin
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: