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Completed

NCT Number: NCT02306447

Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical activity and neck muscles tension.

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Key information

Conditions

Chronic Tinnitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg

Regensburg, Germany, 93053

About this study

Chronic tinnitus is characterized by several comorbid disorders. One of them is neck and back pain. Here, we investigate the feasibility, safety and clinical efficacy of the combination of repetitive transcranial magnetic stimulation (rTMS) and peripheral muscle stimulation (rPMS) in chronic tinnitus in a pilot study. rTMS is considered to interact with neural tinnitus networks. rPMS is suggested to bring relief to muscle tension. This is an one arm study where explorative analyses will be done with special consideration on patients suffering from neck pain in the analysis.

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
  • Acute neck or back pain
  • Neck or back pain of unknown etiology
  • Implants in the neck or back, that are sensitive to magnetic fields

Treatment and study plan

rPMS and rTMS

Device

rPMS Stimulation of the neck muscles in five medial-lateral movements starting from the neck: left and right trapezius and deltoid muscle, trapezius and lattissimus dorsi muslce, and over the backbone. 20 stimuli per movement with 2s inter-train interval; four repetitions for each of the five movements; the first 20 trains with a frequency of 5Hz, the second 20 trains at 20Hz; stimulation at individual comfortable level (20-30% stimulator output); round coil.

rTMS 20Hz stimulation with 2000 stimuli over the left dorso-lateral prefrontal cortex at 110% motor threshold; followed by 1Hz stimulation with 2000 stimuli over the left temporo-parietal cortex; stimulation intensity 110% motor threshold; butterfly coil.

For stimulation we use MagPro X100 (Medtronic, Denmark).

Primary outcomes

  1. Change of tinnitus severity as measured by the tinnitus questionnaire

    Time frame: week 12

Secondary outcomes

  1. Change of tinnitus severity as measured by the tinnitus questionnaire

    Time frame: week 2, week 4, week 12

  2. Change of tinnitus severity as measured by numeric rating scales

    Time frame: week 2, week 4, week 12

  3. Change of depressive symptoms as measured by the major depression inventory

    Time frame: week 2, week 4, week 12

  4. Change in quality of life as measured by the WHOQoL-Bref

    Time frame: week 2, week 4, week 12

  5. Change in neck pain by the neck pain and disability scale

    Time frame: week 2, week 4, week 12

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Acronym: rpms-tinn

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
May 13, 2016

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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