rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

NCT ID: NCT01663324

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-01-31

Brief Summary

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

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.

Conditions

Chronic Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

single site rTMS

Low frequency temporoparietal transcranial magnetic stimulation

Intervention: Device: rTMS intervention 1

Group Type: EXPERIMENTAL

rTMS intervention 1

Intervention Type: DEVICE

Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

Arms: single site rTMS

multisite rTMS

Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation

Intervention: Device: rTMS Intervention 2

Group Type: EXPERIMENTAL

rTMS intervention 2

Intervention Type: DEVICE

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).

Arms: multisite rTMS

Interventions

rTMS intervention 1

Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

Arms: single site rTMS

Intervention Type: 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).

Arms: multisite rTMS

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Dept of Psychiatry

Locations

University of Regensburg- Dept of Psychiatry

Regensburg, , Germany

Countries

Germany

References

Lehner A, Schecklmann M, Greenlee MW, Rupprecht R, Langguth B. Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial. Sci Rep. 2016 Mar 1;6:22302. doi: 10.1038/srep22302.

Reference Type: RESULT

PMID: 26927363 (View on PubMed)

Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269.

Reference Type: DERIVED

PMID: 23968498 (View on PubMed)

Other Identifiers

Uni-Reg-multisite-rTMS-Tin-01

Identifier Type: -

Identifier Source: org_study_id