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

Not Applicable

• Conditions: Tinnitus
• Interventions: Other: transcranial direct current stimulation (tDCS)

• Registration Number: NCT01886729
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Status Verified: 2013-06
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-25
• Last Update Submitted: 2013-06-25
• Study First Posted: 2013-06-26
• Last Update Posted: 2013-06-26
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tDCS simultaneously with hyperbaric oxygen therapy	transcranial direct current stimulation (tDCS)	-
tDCS 3 weeks after start tinnitus	transcranial direct current stimulation (tDCS)	-

Primary Outcome Measures

Name	Time	Method
Improvement of tinnitus	12 weeks	Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire

Secondary Outcome Measures

Name	Time	Method
Hearing	12 weeks	Audiometry, Otoacoustic emissions, Tympanometry, Speech in noise

Trial Locations

Locations (1)

University hospital of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium