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

This study is currently recruiting participants.
Verified August 2012 by University of Regensburg
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01663311
First received: July 23, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Tinnitus
 Device: Medial Frontal rTMS Double-Cone-Coil
Device: Left DLPFC Butterfly Coil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline vs. day 90 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Baseline vs. day 90 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL [ Time Frame: Baseline vs. day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medial Frontal rTMS Double-Cone-Coil
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
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.
Experimental: Left DLPFC Butterfly Coil
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663311

Contacts
Contact: Berthold Langguth, MD, Ph.D. +49 941 941 ext 1256 berthold.langguth@medbo.de

Locations
Germany
University of Regensburg- Dept of Psychiatry Recruiting
Regensburg, Germany, 93053
Contact: Berthold Langguth, MD, Ph.D.     +49 941 941 ext 1256     berthold.langguth@medbo.de    
Principal Investigator: Berthold Langguth, MD, Ph.D.            
Sub-Investigator: Peter Kreuzer, MD, Dr.            
Sub-Investigator: Timm Pöppl, MD, Dr.            
Sub-Investigator: Martin Schecklmann, Ph.D.            
Sub-Investigator: Astrid Lehner, Dipl. Psych.            
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD, Ph.D. University of Regensburg, Dept of Psychiatry
  More Information

No publications provided

Responsible Party: Berthold Langguth, MD, Ph.D., MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT01663311     History of Changes
Other Study ID Numbers: Uni-Reg-Ti-CDC01
Study First Received: July 23, 2012
Last Updated: August 8, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
rTMS
repetitive transcranial magnetic stimulation
chronic tinnitus
subjective tinnitus
double cone coil

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013