Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: transcranial magnetic stimulation (Magstim rapid2); Device: sham stimulation

• Registration Number: NCT00668720
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-29
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	transcranial magnetic stimulation (Magstim rapid2)	-
2	sham stimulation	-

Primary Outcome Measures

Name	Time	Method
Tinnitus severity with the Tinnitus Questionnaire	after treatment, 1 week, 1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory	after treatment, 1 week, 1, 3 and 6 months
Beck Depression Inventory	after treatment, 1 week, 1, 3 and 6 months
State Trait Anxiety Index	after treatment, 1 week, 1, 3 and 6 months
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
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

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands