search
Back to results

Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Combined frontal and temporal rTMS
Temporal low frequency rTMS
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Regensburg - Dept of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Combined frontal and temporal rTMS

Temporal low frequency rTMS

Arm Description

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

temporal low frequency rTMS of auditory cortex

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
Change in quality of life as measured by the WHOQoL

Full Information

First Posted
December 16, 2010
Last Updated
January 7, 2016
Sponsor
University of Regensburg
search

1. Study Identification

Unique Protocol Identification Number
NCT01261949
Brief Title
Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
Official Title
Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined frontal and temporal rTMS
Arm Type
Experimental
Arm Description
Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC
Arm Title
Temporal low frequency rTMS
Arm Type
Experimental
Arm Description
temporal low frequency rTMS of auditory cortex
Intervention Type
Device
Intervention Name(s)
Combined frontal and temporal rTMS
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Temporal low frequency rTMS
Intervention Description
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
Primary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Time Frame
Baseline, Day 12
Secondary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Time Frame
Baseline vs. all follow-up visits
Title
Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
Time Frame
Baseline vs. all follow-up visits
Title
Change in quality of life as measured by the WHOQoL
Time Frame
Baseline vs. all follow-up visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of subjective chronic tinnitus Duration of tinnitus more than 3 months Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD
Organizational Affiliation
University of Regensburg - Dep. of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Dept of Psychiatry
City
Regensburg
State/Province
Bayern
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22069382
Citation
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.
Results Reference
result
Links:
URL
http://www.tinnituszentrum-regensburg.de
Description
Tinnitus Research and Treatment Center at the University of Regensburg

Learn more about this trial

Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

We'll reach out to this number within 24 hrs