Clinical trial NCT05437185: Long-term tDCS Tinnitus Treatment
Official title: The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tDCS
tinnitus
anxiety
depression
neurostimulation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly allocated either to the active or sham (placebo) group.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Functional Index (TFI) at T1 (baseline)
timeFrame: The measurement was established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Tinnitus Functional Index (TFI) at T2
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Tinnitus Functional Index (TFI) at T3
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Tinnitus Functional Index (TFI) at T4
timeFrame: Measured at T4 (6 months since T1)
measure: Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T1 (baseline)
timeFrame: The measurement was established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T2
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T3
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T4
timeFrame: Measured at T4 (6 months since T1)
measure: Beck Anxiety Inventory (BAI) at T1 (baseline)
timeFrame: The measurement was established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T2
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T3
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T4
timeFrame: Measured at T4 (6 months since T1)
measure: Zung Self-Rating Depression Scale (SDS) at T1 (baseline)
timeFrame: The measurement was established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Zung Self-Rating Depression Scale (SDS) at T2
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Zung Self-Rating Depression Scale (SDS) at T3
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Zung Self-Rating Depression Scale (SDS) at T4
timeFrame: Measured at T4 (6 months since T1)
measure: The World Health Organization Quality Of Life (WHOQOL)-BREF at T1 (baseline)
timeFrame: The measurement was established as a baseline prior to the stimulation series. (at T1)
measure: Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 2
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 3
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 4
timeFrame: Measured at T4 (6 months since T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
state: Czech Republic
Study officials:
affiliation: Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
name: Tadeas Mares, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
name: Martin Anders, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
name: Jozef Buday, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.