NCT01663324

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

July 23, 2012

Last Update Submit

May 17, 2016

Conditions

Chronic Tinnitus

Keywords

Tinnituschronic subjective Tinnitustranscranial magnetic stimulationrTMShearing disorders

Outcome Measures

Primary Outcomes (2)

  • Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)

    Day 12

  • Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)

    Day 12

Secondary Outcomes (16)

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

    Day 12

  • Change in quality of life as measured by the WHOQoL

    Day 12

  • Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Day 12

  • Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)

    Day 90

  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Day 12

  • +11 more secondary outcomes

Study Arms (2)

single site rTMS

EXPERIMENTAL

Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1

Device: rTMS intervention 1

multisite rTMS

EXPERIMENTAL

Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2

Device: rTMS intervention 2

Interventions

rTMS intervention 1DEVICE

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

single site rTMS
rTMS intervention 2DEVICE

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

multisite rTMS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of subjective chronic tinnitus
  • THI \> 38
  • 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

Related Publications (2)

  • 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.

    PMID: 26927363RESULT

  • 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.

    PMID: 23968498DERIVED

MeSH Terms

Conditions

TinnitusHearing Disorders

Condition Hierarchy (Ancestors)

Ear 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

August 1, 2014

Study Completion

January 1, 2015

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

DE(1)