Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

Chronic Tinnitus Clinical Trial

— rpms-tinn  

Official title:

Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306447
• Other study ID #: rtms-rpms-tinn
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: May 12, 2016
• Start date: August 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

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).

Locations

Country	Name	City	State
Germany	University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tinnitus severity as measured by the tinnitus questionnaire		week 12	No
Secondary	Change of tinnitus severity as measured by the tinnitus questionnaire		week 2, week 4, week 12	No
Secondary	Change of tinnitus severity as measured by numeric rating scales		week 2, week 4, week 12	No
Secondary	Change of depressive symptoms as measured by the major depression inventory		week 2, week 4, week 12	No
Secondary	Change in quality of life as measured by the WHOQoL-Bref		week 2, week 4, week 12	No
Secondary	Change in neck pain by the neck pain and disability scale		week 2, week 4, week 12	No