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

NCT ID: NCT01886729

Last Updated: 2013-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

NONE

Study Groups

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tDCS simultaneously with hyperbaric oxygen therapy

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type OTHER

tDCS 3 weeks after start tinnitus

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type OTHER

Interventions

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transcranial direct current stimulation (tDCS)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZ Antwerpen

Sarah Rabau

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Antwerp

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sarah Rabau

Role: CONTACT

003238215235

Facility Contacts

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Sarah Rabau

Role: primary

003238215235

Other Identifiers

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EC 11/18/146

Identifier Type: -

Identifier Source: org_study_id

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