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

Tinnitus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01886729
• Other study ID #: EC 11/18/146
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2013
• Last updated: June 25, 2013
• Start date: April 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: Sarah Rabau
• Phone: 003238215235
• Email: sarah.rabau[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: April 2014
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• transcranial direct current stimulation (tDCS)

Locations

Country	Name	City	State
Belgium	University hospital of Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of tinnitus	Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire	12 weeks
Secondary	Hearing	Audiometry, Otoacoustic emissions, Tympanometry, Speech in noise	12 weeks	Yes