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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01886729
First received: June 21, 2013
Last updated: June 25, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 21, 2013
Last Updated: June 25, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014