Effect of Time Shift of Transcranial Direct Current Stimu... | NCT01886729

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

NCT01886729

Sponsor

University Hospital, Antwerp

Status

Unknown status

Last Update Posted

Jun 26, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Tinnitus

Interventions

transcranial direct current stimulation (tDCS)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 21, 2013

First Submission Date that Met QC Criteria

Jun 25, 2013

First Posted Date

Jun 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2013

Last Update Posted Date

Jun 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ethisch Comité UZ Antwerpen, Sarah Rabau, University Hospital, AntwerpPrincipal Investigator

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tDCS simultaneously with hyperbaric oxygen therapy	Active Comparator		Other: transcranial direct current stimulation (tDCS)
tDCS 3 weeks after start tinnitus	Active Comparator		Other: transcranial direct current stimulation (tDCS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcranial direct current stimulation (tDCS)	Other		tDCS 3 weeks after start tinnitus tDCS simultaneously with hyperbaric oxygen therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of tinnitus	Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hearing	Audiometry, Otoacoustic emissions, Tympanometry, Speech in noise	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Rabau	Contact	003238215235		sarah.rabau@uza.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Antwerp	Recruiting	Edegem	Antwerp	2650	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided