NCT02306447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

December 1, 2014

Last Update Submit

May 12, 2016

Conditions

Chronic Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Change of tinnitus severity as measured by the tinnitus questionnaire

    week 12

Secondary Outcomes (5)

  • Change of tinnitus severity as measured by the tinnitus questionnaire

    week 2, week 4, week 12

  • Change of tinnitus severity as measured by numeric rating scales

    week 2, week 4, week 12

  • Change of depressive symptoms as measured by the major depression inventory

    week 2, week 4, week 12

  • Change in quality of life as measured by the WHOQoL-Bref

    week 2, week 4, week 12

  • Change in neck pain by the neck pain and disability scale

    week 2, week 4, week 12

Study Arms (1)

rPMS and rTMS

EXPERIMENTAL

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).

Device: rPMS and rTMS

Interventions

rPMS and rTMSDEVICE

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 and rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bothersome, subjective chronic tinnitus
  • Duration of tinnitus more than 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg

Regensburg, Germany, 93053, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29515350DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Berthold Langguth, MD, PhD

    Department of Psychiatry, University of Regensburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

DE(1)