TinnitusNCT02285803
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
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 aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Mar 2016
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Duration of tinnitus > 6 months
- Maximum loudness of tinnitus on the VAS ≥ 4
- TFI score ≥ 25
Who cannot join
- Pregnancy
- Psychiatric disorders
- Pace maker or defibrillator
- Pulsatile tinnitus
- Acoustic Neurinoma
- CVA
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.
- Conditions
- Tinnitus
- Being tested
- transcranial direct current stimulation (tDCS)
- 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)Device
| Study group | Role | What they receive |
|---|---|---|
| TRT and real tDCS | Active comparator | Not described Receives: Device: transcranial direct current stimulation (tDCS) |
| TRT and sham tDCS | Sham comparator | Not described Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index (TFI)
Measured: 3 months
Secondary outcomes (6)
Hyperacusis Questionnaire
Measured: 3 months
Hospital Anxiety and depression Scale
Measured: 3 months
Patient Global Impression of Change
Measured: 3 months
Psychoacoustic measurements
Measured: 3 months
Late Latency Evoked Potentials
Measured: 3 months
Visual Analogue Scale of Loudness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285803
- Sponsor's protocol ID
- EC 14/40/406
- Status last verified
- Apr 2016
- First submitted
- 31 Oct 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2.
PubMed 26554670
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
- ClinicalTrials.gov ID
- NCT02285803
- Acronym / sponsor ID
- EC 14/40/406
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Nov 2014 (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 aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRT and real tDCS | Active comparator | Device: transcranial direct current stimulation (tDCS) |
| TRT and sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duration of tinnitus > 6 months
- Maximum loudness of tinnitus on the VAS ≥ 4
- TFI score ≥ 25
Key exclusion criteria (6 listed)
- Pregnancy
- Psychiatric disorders
- Pace maker or defibrillator
- Pulsatile tinnitus
- Acoustic Neurinoma
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) | Device | TRT and real tDCS, TRT and sham tDCS |
Primary outcome
Tinnitus Functional Index (TFI)
Time frame: 3 months
6 secondary outcomes
Hyperacusis Questionnaire
Time frame: 3 months
Hospital Anxiety and depression Scale
Time frame: 3 months
Patient Global Impression of Change
Time frame: 3 months
Psychoacoustic measurements
Time frame: 3 months
Late Latency Evoked Potentials
Time frame: 3 months
Visual Analogue Scale of Loudness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Derived from this study: PubMed 26554670Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (TFI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285803, which also lists 1 linked publication.
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 18 Apr 2016.