TinnitusNCT01886729
Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus
A study testing transcranial direct current stimulation (tDCS) in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Who may be able to join
- 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
Who cannot join
- history of epileptic seizures
- severe organic comorbidity
- psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
- Pace maker
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University hospital of Antwerp
Edegem, Antwerp, 2650
Sarah Rabau, 003238215235, sarah.rabau@uza.be
About this study
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.
- Conditions
- Tinnitus
- Being tested
- transcranial direct current stimulation (tDCS)
- Keywords
- transcranial direct current stimulation, time shift
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Other
| Study group | Role | What they receive |
|---|---|---|
| tDCS simultaneously with hyperbaric oxygen therapy | Active comparator | Not described Receives: Other: transcranial direct current stimulation (tDCS) |
| tDCS 3 weeks after start tinnitus | Active comparator | Not described Receives: Other: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of tinnitus
Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire
Measured: 12 weeks
Secondary outcomes (1)
Hearing
Audiometry, Otoacoustic emissions, Tympanometry, Speech in noise
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886729
- Sponsor's protocol ID
- EC 11/18/146
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus
- ClinicalTrials.gov ID
- NCT01886729
- Acronym / sponsor ID
- EC 11/18/146
- Conditions
- Tinnitus
- Keywords
- transcranial direct current stimulation, time shift
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (estimated)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- history of epileptic seizures
- severe organic comorbidity
- psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
- Pace maker
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS) | Other | tDCS 3 weeks after start tinnitus, tDCS simultaneously with hyperbaric oxygen therapy |
Primary outcome
Improvement of tinnitus
Time frame: 12 weeks
Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire
1 secondary outcome
Hearing
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Rabau (003238215235, sarah.rabau@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of tinnitus (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.