NCT01261949

Brief Summary

Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

December 16, 2010

Last Update Submit

January 7, 2016

Conditions

Tinnitus

Keywords

Tinnituschronic subjective tinnitustranscranial magnetic stimulationsensation disordershearing disorders

Outcome Measures

Primary Outcomes (1)

  • Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller

    Baseline, Day 12

Secondary Outcomes (3)

  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12

    Baseline vs. all follow-up visits

  • Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)

    Baseline vs. all follow-up visits

  • Change in quality of life as measured by the WHOQoL

    Baseline vs. all follow-up visits

Study Arms (2)

Combined frontal and temporal rTMS

EXPERIMENTAL

Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC

Device: Combined frontal and temporal rTMS

Temporal low frequency rTMS

EXPERIMENTAL

temporal low frequency rTMS of auditory cortex

Device: Temporal low frequency rTMS

Interventions

Combined frontal and temporal rTMSDEVICE

Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)

Combined frontal and temporal rTMS
Temporal low frequency rTMSDEVICE

Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)

Temporal low frequency rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of subjective chronic tinnitus
  • Duration of tinnitus more than 3 months

You may not qualify if:

  • Objective tinnitus
  • 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
  • Prior treatment with TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg - Dept of Psychiatry

Regensburg, Bavaria, Germany

Location

Related Publications (1)

  • Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.

    PMID: 22069382RESULT

Related Links

MeSH Terms

Conditions

TinnitusSensation DisordersHearing Disorders

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berthold Langguth, MD

    University of Regensburg - Dep. of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 17, 2010

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

DE(1)