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Completed

NCT Number: NCT01663324

rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

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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 associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas 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: Yes

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

Inclusion criteria

  • Diagnosis of subjective chronic tinnitus
  • THI > 38
  • 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

rTMS intervention 1

Device

Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

Arms: single site rTMS

rTMS intervention 2

Device

Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).

Arms: multisite rTMS

Primary outcomes

  1. Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)

    Time frame: Day 12

  2. Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)

    Time frame: Day 12

Secondary outcomes

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

    Time frame: Day 12

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

    Time frame: Day 12

  3. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Time frame: Day 12

  4. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)

    Time frame: Day 90

  5. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Time frame: Day 12

  6. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Time frame: Day 90

  7. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Time frame: Day 180

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

    Time frame: Day 180

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

    Time frame: Day 90

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

    Time frame: Day 90

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

    Time frame: Day 180

  12. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Time frame: Day 90

  13. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Time frame: Day 180

  14. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)

    Time frame: Day 180

  15. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

    Time frame: Day 90

  16. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

    Time frame: Day 180

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

Acronym: Multisite rTMS

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2012
Registry last updated
May 18, 2016

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

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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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