Clinical trial NCT02306447: Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Official title: Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of tinnitus severity as measured by the tinnitus questionnaire
timeFrame: week 12
Secondary outcomes:
measure: Change of tinnitus severity as measured by the tinnitus questionnaire
timeFrame: week 2, week 4, week 12
measure: Change of tinnitus severity as measured by numeric rating scales
timeFrame: week 2, week 4, week 12
measure: Change of depressive symptoms as measured by the major depression inventory
timeFrame: week 2, week 4, week 12
measure: Change in quality of life as measured by the WHOQoL-Bref
timeFrame: week 2, week 4, week 12
measure: Change in neck pain by the neck pain and disability scale
timeFrame: week 2, week 4, week 12
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg
Study officials:
affiliation: Department of Psychiatry, University of Regensburg, Germany
name: Berthold Langguth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.