Trial record 4 of 87 for:
Open Studies | "Hearing Disorders"
rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Triple)
This study is currently recruiting participants.
Verified August 2012 by University of Regensburg
Sponsor:
University of Regensburg
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01663324
First received: July 23, 2012
Last updated: August 8, 2012
Last verified: August 2012
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Purpose
Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.
| Condition | Intervention |
|---|---|
|
Chronic Tinnitus |
Device: rTMS intervention 1 Device: rTMS intervention 2 |
| 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: | Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network |
Resource links provided by NLM:
Further study details as provided by University of Regensburg:
Primary Outcome Measures:
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 12) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: single site rTMS
Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1 |
Device: rTMS intervention 1
Low frequency rTMS (Magventure Mag Pro Option) applied over temporoparietal cortex contralateral to tinnitus sensation (if tinnitus is perceived bilaterally, the left hemisphere is treated): 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.
|
|
Experimental: multisite rTMS
Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2 |
Device: rTMS intervention 2
Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (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 associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas 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: | Yes |
Criteria
Inclusion Criteria:
- Diagnosis of subjective chronic tinnitus
- THI > 38
- 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: NCT01663324
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: | NCT01663324 History of Changes |
| Other Study ID Numbers: | Uni-Reg-multisite-rTMS-Tin-01 |
| Study First Received: | July 23, 2012 |
| Last Updated: | August 8, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Regensburg:
|
Tinnitus chronic subjective Tinnitus transcranial magnetic stimulation rTMS hearing disorders |
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 June 17, 2013