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Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus (rpms-tinn)

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ClinicalTrials.gov Identifier: NCT02306447
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Tinnitus Device: rPMS and rTMS Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: rPMS and rTMS

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).

Device: rPMS and rTMS

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 Outcome Measures :
  1. Change of tinnitus severity as measured by the tinnitus questionnaire [ Time Frame: week 12 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Acute neck or back pain
  • Neck or back pain of unknown etiology
  • Implants in the neck or back, that are sensitive to magnetic fields

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306447


Locations
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Germany
University of Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Berthold Langguth, MD, PhD Department of Psychiatry, University of Regensburg, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berthold Langguth, MD, Ph.D., MD, PhD, University of Regensburg
ClinicalTrials.gov Identifier: NCT02306447     History of Changes
Other Study ID Numbers: rtms-rpms-tinn
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms