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Completed

NCT Number: NCT01663311

Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg- Dept of Psychiatry

Regensburg, 93053, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medial Frontal rTMS Double-Cone-Coil

Device

High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Left DLPFC Butterfly Coil

Device

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Primary outcomes

  1. Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12)

    Time frame: Day 12

Secondary outcomes

  1. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12

    Time frame: Baseline vs. day 90

  2. Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

    Time frame: Baseline vs. day 90

  3. Change in quality of life as measured by the WHOQoL

    Time frame: Baseline vs. day 90

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)

Acronym: Ti-CDC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2012
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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