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Completed

NCT Number: NCT01907022

Combined rTMS and Relaxation in Chronic Tinnitus

Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

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Key information

Conditions

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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a 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

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. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.

Arms: Left DLPFC Butterfly Coil

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 4

  2. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

    Time frame: Week 4

  3. Change of tinnitus severity as measured by the Tinnitus Severity Scale

    Time frame: Week 4

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

    Time frame: Week 2

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

    Time frame: Week 2

  6. Change of tinnitus severity as measured by the Tinnitus Severity Scale

    Time frame: Week 2

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

    Time frame: Week 4

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

    Time frame: Week 2

  9. Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

    Time frame: Week 2

  10. Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)

    Time frame: Week 4

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

    Time frame: Week 12

  12. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

    Time frame: Week 12

  13. Change of tinnitus severity as measured by the Tinnitus Severity Scale

    Time frame: Week 12

  14. Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus

Acronym: RELAX

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Mar 12, 2015

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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