- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02306447
Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus (rpms-tinn)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Regensburg, Germany, 93053
- University of Regensburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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). |
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of tinnitus severity as measured by the tinnitus questionnaire
Time Frame: week 12
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of tinnitus severity as measured by the tinnitus questionnaire
Time Frame: week 2, week 4, week 12
|
week 2, week 4, week 12
|
Change of tinnitus severity as measured by numeric rating scales
Time Frame: week 2, week 4, week 12
|
week 2, week 4, week 12
|
Change of depressive symptoms as measured by the major depression inventory
Time Frame: week 2, week 4, week 12
|
week 2, week 4, week 12
|
Change in quality of life as measured by the WHOQoL-Bref
Time Frame: week 2, week 4, week 12
|
week 2, week 4, week 12
|
Change in neck pain by the neck pain and disability scale
Time Frame: week 2, week 4, week 12
|
week 2, week 4, week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, PhD, Department of Psychiatry, University of Regensburg, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rtms-rpms-tinn
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Tinnitus
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Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
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State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
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University of RegensburgCompleted
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University of RegensburgCompleted
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University of RegensburgCompletedChronic TinnitusGermany
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University of RegensburgCompletedChronic TinnitusGermany
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