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

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
rPMS and rTMS
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rPMS and rTMS

Arm Description

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).

Outcomes

Primary Outcome Measures

Change of tinnitus severity as measured by the tinnitus questionnaire

Secondary Outcome Measures

Change of tinnitus severity as measured by the tinnitus questionnaire
Change of tinnitus severity as measured by numeric rating scales
Change of depressive symptoms as measured by the major depression inventory
Change in quality of life as measured by the WHOQoL-Bref
Change in neck pain by the neck pain and disability scale

Full Information

First Posted
December 1, 2014
Last Updated
May 12, 2016
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02306447
Brief Title
Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Acronym
rpms-tinn
Official Title
Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rPMS and rTMS
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
rPMS and rTMS
Intervention Description
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 Measure Information:
Title
Change of tinnitus severity as measured by the tinnitus questionnaire
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the tinnitus questionnaire
Time Frame
week 2, week 4, week 12
Title
Change of tinnitus severity as measured by numeric rating scales
Time Frame
week 2, week 4, week 12
Title
Change of depressive symptoms as measured by the major depression inventory
Time Frame
week 2, week 4, week 12
Title
Change in quality of life as measured by the WHOQoL-Bref
Time Frame
week 2, week 4, week 12
Title
Change in neck pain by the neck pain and disability scale
Time Frame
week 2, week 4, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, PhD
Organizational Affiliation
Department of Psychiatry, University of Regensburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29515350
Citation
Vielsmeier V, Schecklmann M, Schlee W, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B, Lehner A. A Pilot Study of Peripheral Muscle Magnetic Stimulation as Add-on Treatment to Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus. Front Neurosci. 2018 Feb 20;12:68. doi: 10.3389/fnins.2018.00068. eCollection 2018.
Results Reference
derived

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Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

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