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Completed

NCT Number: NCT05437185

Long-term tDCS Tinnitus Treatment

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.

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Key information

Conditions

Tinnitus Anxiety Disorders Behavior Behavioral Symptoms Depression Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague

Prague, Czech Republic, 12000, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nonpulsatile tinnitus for at least 6 months
  • 18 and more years of age

Exclusion criteria

  • Pregnancy
  • Unstable cardiovascular condition
  • History of seizures
  • Intracranial masses
  • Intracranial metalic objects
  • History of alcohol or drug abuse
  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 Stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2022
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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