Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
transcranial magnetic stimulation (Magstim rapid2)
sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria:
- Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
- Age ≥18 years
- Dutch speaking
Exclusion Criteria:
- Treatable cause of the tinnitus
- Use of anticonvulsant medication or other psychotherapeutic drugs
- History of epilepsy or family members with epilepsy
- Presence of active migraine
- Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
- Metal objects in and around body that can not be removed
- Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
- Alcohol or drug abuse
- Prior treatment with TMS
Sites / Locations
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Tinnitus severity with the Tinnitus Questionnaire
Secondary Outcome Measures
Tinnitus Handicap Inventory
Beck Depression Inventory
State Trait Anxiety Index
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668720
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
Official Title
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition 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. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, transcranial magnetic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation (Magstim rapid2)
Other Intervention Name(s)
Magstim rapid2
Intervention Description
Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days
Primary Outcome Measure Information:
Title
Tinnitus severity with the Tinnitus Questionnaire
Time Frame
after treatment, 1 week, 1, 3 and 6 months
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory
Time Frame
after treatment, 1 week, 1, 3 and 6 months
Title
Beck Depression Inventory
Time Frame
after treatment, 1 week, 1, 3 and 6 months
Title
State Trait Anxiety Index
Time Frame
after treatment, 1 week, 1, 3 and 6 months
Title
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
Time Frame
for the first three months daily and for the second three months monthly
Title
Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)
Time Frame
1 week after treatment and after 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
Age ≥18 years
Dutch speaking
Exclusion Criteria:
Treatable cause of the tinnitus
Use of anticonvulsant medication or other psychotherapeutic drugs
History of epilepsy or family members with epilepsy
Presence of active migraine
Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
Metal objects in and around body that can not be removed
Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
Alcohol or drug abuse
Prior treatment with TMS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert A van Zanten, AuD
Organizational Affiliation
Dept. of Otorhinolaryngology, University Medical Center Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24157459
Citation
Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.
Results Reference
derived
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
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