NCT01886729

Brief Summary

The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to the protocol. The purpose is to determine the effect of the time shift of tDCS. Two conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3 weeks after the start of the tinnitus. An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and 12 weeks.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 21, 2013

Last Update Submit

June 25, 2013

Conditions

Tinnitus

Keywords

transcranial direct current stimulationtime shift

Outcome Measures

Primary Outcomes (1)

  • Improvement of tinnitus

    Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire

    12 weeks

Secondary Outcomes (1)

  • Hearing

    12 weeks

Study Arms (2)

tDCS simultaneously with hyperbaric oxygen therapy

ACTIVE COMPARATOR
Other: transcranial direct current stimulation (tDCS)

tDCS 3 weeks after start tinnitus

ACTIVE COMPARATOR
Other: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS)OTHER
tDCS 3 weeks after start tinnitustDCS simultaneously with hyperbaric oxygen therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 50 years
  • presence of acute tinnitus or worsening of tinnitus caused by otogenic disease
  • registration in UZA within 48 hours after start tinnitus
  • VAS-score ≥ 4
  • ability to understand and sign informed consent

You may not qualify if:

  • history of epileptic seizures
  • severe organic comorbidity
  • psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
  • Pace maker
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Sarah Rabau

CONTACT

003238215235sarah.rabau@uza.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sarah Rabau

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 26, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

BE(1)