Clinical trial NCT01663311: Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: rTMS
repetitive transcranial magnetic stimulation
chronic tinnitus
subjective tinnitus
double cone coil
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.

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 remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Low-frequency rTMS applied to the temporoparietal areas has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account affective components of the multiple overlapping neural networks responsible for the generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed coil, the so-called double cone coil will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* Duration of tinnitus more than 6 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

Primary outcomes:
measure: Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12)
timeFrame: Day 12
Secondary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
timeFrame: Baseline vs. day 90
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Baseline vs. day 90
measure: Change in quality of life as measured by the WHOQoL
timeFrame: Baseline vs. day 90
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg- Dept of Psychiatry
Study officials:
affiliation: University of Regensburg, Dept of Psychiatry
name: Berthold Langguth, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: