NCT01663311

Brief Summary

Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

July 23, 2012

Last Update Submit

April 25, 2014

Conditions

Chronic Tinnitus

Keywords

rTMSrepetitive transcranial magnetic stimulationchronic tinnitussubjective tinnitusdouble cone coil

Outcome Measures

Primary Outcomes (1)

  • Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12)

    Day 12

Secondary Outcomes (3)

  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12

    Baseline vs. day 90

  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

    Baseline vs. day 90

  • Change in quality of life as measured by the WHOQoL

    Baseline vs. day 90

Study Arms (2)

Medial Frontal rTMS Double-Cone-Coil

EXPERIMENTAL

High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Device: Medial Frontal rTMS Double-Cone-Coil

Left DLPFC Butterfly Coil

EXPERIMENTAL

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Device: Left DLPFC Butterfly Coil

Interventions

Medial Frontal rTMS Double-Cone-CoilDEVICE

High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Medial Frontal rTMS Double-Cone-Coil
Left DLPFC Butterfly CoilDEVICE

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.

Left DLPFC Butterfly Coil

Eligibility Criteria

Age18 Years - 70 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
  • Prior treatment with TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg- Dept of Psychiatry

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berthold Langguth, MD, Ph.D.

    University of Regensburg, Dept of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

July 23, 2012

First Posted

August 13, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations

DE(1)