Long-term tDCS Tinnitus Treatment
The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedJune 29, 2022
June 1, 2022
2.5 years
June 20, 2022
June 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
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.
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 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 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 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.
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 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 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 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.
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 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 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 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.
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 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 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 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.
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 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 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 at T4 (6 months since T1)
Study Arms (2)
Active group
ACTIVE COMPARATORThe 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 COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Nonpulsatile tinnitus for at least 6 months
- and more years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Prague, Czech Republic, 12000, Czechia
Related Publications (1)
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.
PMID: 36311525DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tadeas Mares, M.D.
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
- STUDY DIRECTOR
Martin Anders, M.D., Ph.D.
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
- PRINCIPAL INVESTIGATOR
Jozef Buday, M.D., Ph.D.
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participants were distributed between 2 arms using an aperiodic, nondeterministic, atmospheric random noise randomization algorithm. The stimulation type was unblinded upon completing all the follow-ups or dropping out. The blinding was ensured by a dedicated team member with no direct access to the participants or their data.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Neurostimulation Center; Assistant Professor
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 29, 2022
Study Start
September 1, 2019
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available after the final publication, indefinitely
- Access Criteria
- Upon individual request by a verified researcher.
IPD can be shared upon request from a verified researcher.