Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

Tinnitus Clinical Trial

Official title:

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668720
• Other study ID #: rTMS_tinnitus_Utrecht
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: June 29, 2011
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• transcranial magnetic stimulation (Magstim rapid2)
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.
• sham stimulation
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

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus severity with the Tinnitus Questionnaire		after treatment, 1 week, 1, 3 and 6 months	No
Secondary	Tinnitus Handicap Inventory		after treatment, 1 week, 1, 3 and 6 months	No
Secondary	Beck Depression Inventory		after treatment, 1 week, 1, 3 and 6 months	No
Secondary	State Trait Anxiety Index		after treatment, 1 week, 1, 3 and 6 months	No
Secondary	Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.		for the first three months daily and for the second three months monthly	No
Secondary	Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)		1 week after treatment and after 3 and 6 months	No