Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
rTMS - Intervention 1
rTMS - Intervention 2
Sponsored by
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
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
1
2
Arm Description
Combined frontal and temporal transcranial magnetic stimulation
Temporal transcranial magnetic stimulation
Outcomes
Primary Outcome Measures
tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Secondary Outcome Measures
Full Information
NCT ID
NCT00876720
First Posted
April 6, 2009
Last Updated
November 12, 2010
Sponsor
University of Regensburg
1. Study Identification
Unique Protocol Identification Number
NCT00876720
Brief Title
Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Official Title
Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
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 high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high 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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Combined frontal and temporal transcranial magnetic stimulation
Arm Title
2
Arm Type
Experimental
Arm Description
Temporal transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
rTMS - Intervention 1
Intervention Description
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 20Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
Intervention Type
Device
Intervention Name(s)
rTMS - Intervention 2
Intervention Description
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
Primary Outcome Measure Information:
Title
tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Time Frame
Baseline, Day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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-Dept of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Dept of Psychiatry
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.tinnituszentrum-regensburg.de/index.php
Description
Tinnitus Research and Treatment Center at the University of Regensburg
Learn more about this trial
Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
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