TinnitusNCT05437185
Long-term tDCS Tinnitus Treatment
A study testing Transcranial Direct Current Stimulation in people with Tinnitus, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The study was designed to evaluate a therapeutic effect of tDCS in the treatment of tinnitus and its comorbidities (anxiety, depresion) and to evaluate the associated quality of life. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2019to 28 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonpulsatile tinnitus for at least 6 months
- 18 and more years of age
Who cannot join
- Pregnancy
- Unstable cardiovascular condition
- History of seizures
- Intracranial masses
- Intracranial metalic objects
- History of alcohol or drug abuse
Show all 10Show fewer
- Unwillingness to sign the informed consent
- Inability to pass the follow-up
- Unstable medication for at least 6 months prior to the enrollment
- Other stimulation method for at least 6 months prior to the enrollmment
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Prague, Czech Republic, 12000
About this study
Official title: The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities
The study was designed to evaluate a therapeutic effect of tDCS in the treatment of tinnitus and its comorbidities (anxiety, depresion) and to evaluate the associated quality of life.
In the randomized, double-blinded, sham-controlled trial, 39 participants (active n=19, sham n=20) underwent bilateral dorsolateral prefrontal cortex (DLPFC) tDCS (anode over right DLPFC, cathode left DLPFC, current of 1.5 mA, 20 minutes, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and six months.
Read the detailed description
A prospective, randomized, double-blinded, placebo-controlled, two-arm trial was conducted at the Department of Psychiatry, General University Hospital in Prague, Czechia. The research was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of General University Hospital in Prague, Czechia, in 2019 under the reference number 531/19 S-IV.
Participants were recruited through the recruitment campaign of the Department of Psychiatry, which was supported by outpatient services of several neurological, psychiatric, internal, and otorhinolaryngological departments in several university hospitals around Prague. All participants were required to sign written consent with the trial, anonymized data, the European Union General Data Protection Regulation (GDPR), and were fully informed about the trial's goals, risks, and requirements. Participation was not associated with any financial reward.
The participation was offered to persons at least 18 years of age (on the day of signing the consent) with a history of tinnitus lasting at least six months. The investigators excluded persons contraindicated to tDCS - such as those with epilepsy, intracranial masses or metallic objects, pregnancy, and heart conditions. The investigators also excluded persons with a history of alcohol and drug abuse, persons unwilling to sign the informed consent or persons who underwent any other tinnitus therapy in the last six months. The investigators intended to discontinue the treatment in any participant developing any severe adverse effect (significant exacerbation of tinnitus, epileptic seizure, severe headache, or any adverse effect deemed severe enough by the participants) and in participants noncompliant or unwilling to participate further with the trial and its follow-ups. The investigators required the participants not to alter their medication at least six months before the trial if any was used.
- Conditions
- Tinnitus
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Keywords
- tDCS, tinnitus, anxiety, depression, neurostimulation
- Medical subject headings
- Tinnitus, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes.
Sham Transcranial Direct Current StimulationDevice
The sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The investigators aimed for six sessions of anodal stimulation over the right DLPFC (F4 in 10-20 EEG system) with cathode above the left DLPFC (F3) using HDCstim by Newronika S.r.l., Italy. The therapy was administered over two weeks (Mon, Wed, Fri) to ensure a washout period of 48 to 72 hours between applications. The current of 1.5 mA was delivered via silicone electrodes inserted into saline (0.9%) filled cellulose sponges, both 5x5cm (Current Density of 0.6 A/m2), for 20 minutes with 20 seconds of both ramp-up and ramp-down. An International 10-20 EEG system was used to determine the stimulation location, and dedicated EEG caps were used to ensure consistency between applications. Receives: Device: Transcranial Direct Current Stimulation |
| Sham group | Placebo comparator | The sham (placebo) was administered using the same devices with a preprogrammed sham protocol (using HDCprog by Newronika S.r.l., Italy) of 20 minutes to be virtually indistinguishable from the active stimulation. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index (TFI) at T1 (baseline)
A questionaire evaluating 8 subdomains of tinnitus. A total minimal score=0, maximum score=250. Higher score means generally more severe form of tinnitus.
Measured: The measurement was established as a baseline prior to the stimulation series. (at T1)
Changes in Tinnitus Functional Index (TFI) at T2
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Tinnitus Functional Index (TFI) at T3
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T3 (6 weeks since T1)
Changes in Tinnitus Functional Index (TFI) at T4
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T4 (6 months since T1)
Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T1 (baseline)
A questionnaire evaluating 3 subdomains of tinnitus and its handicap. A total minimal score=0 %, maximum score=100%. Higher score means generally more severe form of tinnitus.
Measured: The measurement was established as a baseline prior to the stimulation series. (at T1)
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T2
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T3
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T3 (6 weeks since T1)
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T4
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T4 (6 months since T1)
Beck Anxiety Inventory (BAI) at T1 (baseline)
A standardized questionaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score means generally more severe anxiety.
Measured: The measurement was established as a baseline prior to the stimulation series. (at T1)
Changes in Beck Anxiety Inventory (BAI) at T2
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T3
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T3 (6 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T4
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T4 (6 months since T1)
Zung Self-Rating Depression Scale (SDS) at T1 (baseline)
A standardized questionaire focusing on symptoms of depression. The scale calculates SDS index from the raw data - minimal SDS index=25 points; maximal SDS index=100 points. Higher SDS index means generally more severe depression.
Measured: The measurement was established as a baseline prior to the stimulation series. (at T1)
Changes in Zung Self-Rating Depression Scale (SDS) at T2
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Zung Self-Rating Depression Scale (SDS) at T3
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T3 (6 weeks since T1)
Changes in Zung Self-Rating Depression Scale (SDS) at T4
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T4 (6 months since T1)
The World Health Organization Quality Of Life (WHOQOL)-BREF at T1 (baseline)
An abbreviated version of WHO questionaire evaluating 4 domains of quality of life during the therapy. The outcomes are calculatefd are on a scale ranging between 0-100%. Higher scores mean generally higher perceived quality of life.
Measured: The measurement was established as a baseline prior to the stimulation series. (at T1)
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 2
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 3
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T3 (6 weeks since T1)
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 4
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Measured: Measured at T4 (6 months since T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- 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
- Model description
- Participants were randomly allocated either to the active or sham (placebo) group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jozef Buday, Charles University, Czech Republic
- Investigators
- Tadeas Mares, M.D., Principal investigator, Psychiatric Department, General University Hospital and 1st Faculty of Medicine, PragueMartin Anders, M.D., Ph.D., Study director, Psychiatric Department, General University Hospital and 1st Faculty of Medicine, PragueJozef Buday, M.D., Ph.D., Principal investigator, Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437185
- Sponsor's protocol ID
- 531/19 S-IV
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared upon request from a verified researcher.
Publications
Mares T, Albrecht J, Buday J, Podgorna G, Le TH, Magyarova E, Poshor K, Halik J, Buna J, Capek V, Kostylkova L, Klasova J, Fabian V, Anders M. Long-term effect of transcranial direct current stimulation in the treatment of chronic tinnitus: A randomized, placebo-controlled trial. Front Psychiatry. 2022 Oct 13;13:969800. doi: 10.3389/fpsyt.2022.969800. eCollection 2022.
PubMed 36311525
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities
- ClinicalTrials.gov ID
- NCT05437185
- Acronym / sponsor ID
- 531/19 S-IV
- Conditions
- Tinnitus
- Keywords
- tDCS, tinnitus, anxiety, depression, neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Jun 2022 (actual)
- 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 study was designed to evaluate a therapeutic effect of tDCS in the treatment of tinnitus and its comorbidities (anxiety, depresion) and to evaluate the associated quality of life.
In the randomized, double-blinded, sham-controlled trial, 39 participants (active n=19, sham n=20) underwent bilateral dorsolateral prefrontal cortex (DLPFC) tDCS (anode over right DLPFC, cathode left DLPFC, current of 1.5 mA, 20 minutes, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and six months.
Detailed description
A prospective, randomized, double-blinded, placebo-controlled, two-arm trial was conducted at the Department of Psychiatry, General University Hospital in Prague, Czechia. The research was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of General University Hospital in Prague, Czechia, in 2019 under the reference number 531/19 S-IV.
Participants were recruited through the recruitment campaign of the Department of Psychiatry, which was supported by outpatient services of several neurological, psychiatric, internal, and otorhinolaryngological departments in several university hospitals around Prague. All participants were required to sign written consent with the trial, anonymized data, the European Union General Data Protection Regulation (GDPR), and were fully informed about the trial's goals, risks, and requirements. Participation was not associated with any financial reward.
The participation was offered to persons at least 18 years of age (on the day of signing the consent) with a history of tinnitus lasting at least six months. The investigators excluded persons contraindicated to tDCS - such as those with epilepsy, intracranial masses or metallic objects, pregnancy, and heart conditions. The investigators also excluded persons with a history of alcohol and drug abuse, persons unwilling to sign the informed consent or persons who underwent any other tinnitus therapy in the last six months. The investigators intended to discontinue the treatment in any participant developing any severe adverse effect (significant exacerbation of tinnitus, epileptic seizure, severe headache, or any adverse effect deemed severe enough by the participants) and in participants noncompliant or unwilling to participate further with the trial and its follow-ups. The investigators required the participants not to alter their medication at least six months before the trial if any was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated either to the active or sham (placebo) group.
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: Transcranial Direct Current StimulationThe investigators aimed for six sessions of anodal stimulation over the right DLPFC (F4 in 10-20 EEG system) with cathode above the left DLPFC (F3) using HDCstim by Newronika S.r.l., Italy. The therapy was administered over two weeks (Mon, Wed, Fri) to ensure a washout period of 48 to 72 hours between applications. The current of 1.5 mA was delivered via silicone electrodes inserted into saline (0.9%) filled cellulose sponges, both 5x5cm (Current Density of 0.6 A/m2), for 20 minutes with 20 seconds of both ramp-up and ramp-down. An International 10-20 EEG system was used to determine the stimulation location, and dedicated EEG caps were used to ensure consistency between applications. |
| Sham group | Placebo comparator | Device: Sham Transcranial Direct Current StimulationThe sham (placebo) was administered using the same devices with a preprogrammed sham protocol (using HDCprog by Newronika S.r.l., Italy) of 20 minutes to be virtually indistinguishable from the active stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nonpulsatile tinnitus for at least 6 months
- 18 and more years of age
Key exclusion criteria (10 listed)
- Pregnancy
- Unstable cardiovascular condition
- History of seizures
- Intracranial masses
- Intracranial metalic objects
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 StimulationTranscranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes. | Device | Active group |
| Sham Transcranial Direct Current StimulationThe sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation. | Device | Sham group |
Primary outcome
Tinnitus Functional Index (TFI) at T1 (baseline)
Time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)
A questionaire evaluating 8 subdomains of tinnitus. A total minimal score=0, maximum score=250. Higher score means generally more severe form of tinnitus.
Changes in Tinnitus Functional Index (TFI) at T2
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Tinnitus Functional Index (TFI) at T3
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Tinnitus Functional Index (TFI) at T4
Time frame: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T1 (baseline)
Time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)
A questionnaire evaluating 3 subdomains of tinnitus and its handicap. A total minimal score=0 %, maximum score=100%. Higher score means generally more severe form of tinnitus.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T2
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T3
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T4
Time frame: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Beck Anxiety Inventory (BAI) at T1 (baseline)
Time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)
A standardized questionaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score means generally more severe anxiety.
Changes in Beck Anxiety Inventory (BAI) at T2
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Beck Anxiety Inventory (BAI) at T3
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Beck Anxiety Inventory (BAI) at T4
Time frame: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Zung Self-Rating Depression Scale (SDS) at T1 (baseline)
Time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)
A standardized questionaire focusing on symptoms of depression. The scale calculates SDS index from the raw data - minimal SDS index=25 points; maximal SDS index=100 points. Higher SDS index means generally more severe depression.
Changes in Zung Self-Rating Depression Scale (SDS) at T2
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Zung Self-Rating Depression Scale (SDS) at T3
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Zung Self-Rating Depression Scale (SDS) at T4
Time frame: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
The World Health Organization Quality Of Life (WHOQOL)-BREF at T1 (baseline)
Time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)
An abbreviated version of WHO questionaire evaluating 4 domains of quality of life during the therapy. The outcomes are calculatefd are on a scale ranging between 0-100%. Higher scores mean generally higher perceived quality of life.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 2
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 3
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 4
Time frame: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
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 29 Jun 2022.
- Derived from this study: PubMed 36311525Mares T, Albrecht J, Buday J, Podgorna G, Le TH, Magyarova E, Poshor K, Halik J, Buna J, Capek V, Kostylkova L, Klasova J, Fabian V, Anders M. Long-term effect of transcranial direct current stimulation in the treatment of chronic tinnitus: A randomized, placebo-controlled trial. Front Psychiatry. 2022 Oct 13;13:969800. doi: 10.3389/fpsyt.2022.969800. eCollection 2022.
- Individual participant dataSharing planned: Yes. IPD can be shared upon request from a verified researcher.
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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.
Tadeas Mares, M.D. principal investigator
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Martin Anders, M.D., Ph.D. study director
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Jozef Buday, M.D., Ph.D. principal investigator
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
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 in people with Tinnitus, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 inclusion and 10 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 29 Jun 2022. 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 Czechia. 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) at T1 (baseline) (time frame: The measurement was established as a baseline prior to the stimulation series. (at T1)). The study lists 20 primary outcomes in all. 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 NCT05437185, 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 29 Jun 2022.