Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

NCT ID: NCT02306447

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Chronic Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

rPMS and rTMS

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, University of Regensburg, Germany

Locations

University of Regensburg

Regensburg, Germany, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29515350 (View on PubMed)

Other Identifiers

rtms-rpms-tinn

Identifier Type: -

Identifier Source: org_study_id