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Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

U

University Hospital Tuebingen

Status and phase

Completed
Phase 2

Conditions

Tinnitus

Treatments

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00518024
PL 525/1-1

Details and patient eligibility

About

Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. There are currently no causal treatments. Using repetitive transcranial magnetic stimulation (rTMS), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment strategy against tinnitus. At this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. Moreover, the optimal stimulation area is unclear.

Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjective tinnitus > 6 mo , < 5 ys

Exclusion criteria

  • Objective tinnitus
  • Seizures
  • Brain trauma
  • Brain surgery
  • Pacemaker
  • intake of: benzodiazepines, antiepileptics, neuroleptics
  • Suicidality

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 3 patient groups

1
Experimental group
Description:
Bilateral theta burst stimulation to the secondary auditory cortex
Treatment:
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
2
Experimental group
Description:
Bilateral theta burst stimulation to the tertiary auditory cortex
Treatment:
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
3
Sham Comparator group
Description:
Bilateral theta burst stimulation to a non-cortical region
Treatment:
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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