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Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus (Ti-CDC)

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Medial Frontal rTMS Double-Cone-Coil
Left DLPFC Butterfly Coil
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus focused on measuring rTMS, repetitive transcranial magnetic stimulation, chronic tinnitus, subjective tinnitus, double cone coil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Prior treatment with TMS

Sites / Locations

  • University of Regensburg- Dept of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Medial Frontal rTMS Double-Cone-Coil

Left DLPFC Butterfly Coil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Change in quality of life as measured by the WHOQoL

Full Information

First Posted
July 23, 2012
Last Updated
April 25, 2014
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01663311
Brief Title
Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus
Acronym
Ti-CDC
Official Title
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Low-frequency rTMS applied to the temporoparietal areas has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account affective components of the multiple overlapping neural networks responsible for the generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed coil, the so-called double cone coil will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
rTMS, repetitive transcranial magnetic stimulation, chronic tinnitus, subjective tinnitus, double cone coil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medial Frontal rTMS Double-Cone-Coil
Arm Type
Experimental
Arm Description
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.
Arm Title
Left DLPFC Butterfly Coil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medial Frontal rTMS Double-Cone-Coil
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Left DLPFC Butterfly Coil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12)
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Time Frame
Baseline vs. day 90
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Baseline vs. day 90
Title
Change in quality of life as measured by the WHOQoL
Time Frame
Baseline vs. day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 Prior treatment with TMS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, Ph.D.
Organizational Affiliation
University of Regensburg, Dept of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg- Dept of Psychiatry
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus

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