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Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886729
First Posted: June 26, 2013
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
  Purpose

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.


Condition Intervention
Tinnitus Other: transcranial direct current stimulation (tDCS)

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:

Primary Outcome Measures:
  • Improvement of tinnitus [ Time Frame: 12 weeks ]
    Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire


Secondary Outcome Measures:
  • Hearing [ Time Frame: 12 weeks ]
    Audiometry, Otoacoustic emissions, Tympanometry, Speech in noise


Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS simultaneously with hyperbaric oxygen therapy Other: transcranial direct current stimulation (tDCS)
Active Comparator: tDCS 3 weeks after start tinnitus Other: transcranial direct current stimulation (tDCS)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of epileptic seizures
  • severe organic comorbidity
  • psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
  • Pace maker
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886729


Contacts
Contact: Sarah Rabau 003238215235 sarah.rabau@uza.be

Locations
Belgium
University hospital of Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Sarah Rabau    003238215235    sarah.rabau@uza.be   
Sponsors and Collaborators
University Hospital, Antwerp
  More Information

Responsible Party: Ethisch Comité UZ Antwerpen, Sarah Rabau, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01886729     History of Changes
Other Study ID Numbers: EC 11/18/146
First Submitted: June 21, 2013
First Posted: June 26, 2013
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:
transcranial direct current stimulation
time shift

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms