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Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus (tRNS-tin)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Regensburg
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01965028
First received: October 14, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Tinnitus
Device: Transcranial random noise stimulation (tRNS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of tinnitus severity as measured by the Tinnitus Questionnaire [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionnaire [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL-Bref [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL-Bref [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL-Bref [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial random noise stimulation (tRNS)
High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4
Device: Transcranial random noise stimulation (tRNS)
High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965028

Contacts
Contact: Berthold Langguth, MD, Ph.D. +49 941 ext 1256 berthold.langguth@medbo.de
Contact: Martin Schecklmann, Ph.D. +49 941 ext 2054 martin.schecklmann@medbo.de

Locations
Germany
University of Regensburg - Dept of Psychiatry Recruiting
Regensburg, Germany
Contact: Berthold Langguth, M.D., Ph.D.    +49 941 941 ext 1256    berthold.langguth@medbo.de   
Contact: Martin Schecklmann, Ph.D.    +49 941 941 ext 2054    martin.schecklmann@medbo.de   
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD, Ph.D. University of Regensburg
  More Information

No publications provided

Responsible Party: Berthold Langguth, MD, Ph.D., M.D., Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT01965028     History of Changes
Other Study ID Numbers: Uni-Reg-tRNS01
Study First Received: October 14, 2013
Last Updated: July 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
tinnitus
transcranial random noise stimulation
tRNS
auditory cortex
non-invasive brain stimulation

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014