NCT01965028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

October 14, 2013

Last Update Submit

March 4, 2016

Conditions

Chronic Tinnitus

Keywords

tinnitustranscranial random noise stimulationtRNSauditory cortexnon-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

  • Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)

    Week 12

Secondary Outcomes (12)

  • Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Week 2

  • Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Week 4

  • Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Week 12

  • Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales

    Week 2

  • Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales

    Week 4

  • +7 more secondary outcomes

Study Arms (1)

Transcranial random noise stimulation (tRNS)

EXPERIMENTAL

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)

Interventions

Transcranial random noise stimulation (tRNS)DEVICE

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

Transcranial random noise stimulation (tRNS)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg - Dept of Psychiatry

Regensburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31439873DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Berthold Langguth, MD, Ph.D.

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 18, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

DE(1)