Tinnitus, SubjectiveNCT04565132
HD-tDCS as a Treatment for Chronic Tinnitus
A study testing High Definition transcranial Direct Current Stimulation in people with Tinnitus, Subjective, run by University Hospital, Antwerp.
Trial summary
Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- High Definition transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2016to 9 Apr 2019
- 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
- chronic, subjective, non-pulsatile tinnitus
- met the criteria for HD-tDCS safety
Who cannot join
- a middle ear pathology
- another tinnitus treatment ongoing
About this study
Official title: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study
Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.
- Conditions
- Tinnitus, Subjective
- Being tested
- High Definition transcranial Direct Current Stimulation
- Keywords
- tinnitus, neuromodulation, non-invasive brain stimulation, transcranial direct current stimulation, large cohort, high-definition tDCS
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Definition transcranial Direct Current StimulationDevice
1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)
| Study group | Role | What they receive |
|---|---|---|
| HD-tDCS | Experimental | Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC. Receives: Device: High Definition transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Functional Index (TFI)
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus
Measured: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Secondary outcomes (4)
Change in Visual Analogue scale (VAS) for tinnitus loudness
Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Measured: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hospital Anxiety and Depression Scale (HADS)
Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Measured: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Tinnitus Questionnaire (TQ)
Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus
Measured: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hyperacusis Questionnaire (HQ)
Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.
Measured: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start21 Oct 2016
- Primary completion8 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565132
- Sponsor's protocol ID
- HDtDCS_extensive
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacquemin L, Shekhawat GS, Van de Heyning P, Mertens G, Fransen E, Van Rompaey V, Topsakal V, Moyaert J, Beyers J, Gilles A. Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. Neurorehabil Neural Repair. 2018 Aug;32(8):714-723. doi: 10.1177/1545968318787916. Epub 2018 Jul 18.
PubMed 30019630Shekhawat GS, Sundram F, Bikson M, Truong D, De Ridder D, Stinear CM, Welch D, Searchfield GD. Intensity, Duration, and Location of High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief. Neurorehabil Neural Repair. 2016 May;30(4):349-59. doi: 10.1177/1545968315595286. Epub 2015 Jul 15.
PubMed 26180052Shekhawat GS, Vanneste S. High-definition transcranial direct current stimulation of the dorsolateral prefrontal cortex for tinnitus modulation: a preliminary trial. J Neural Transm (Vienna). 2018 Feb;125(2):163-171. doi: 10.1007/s00702-017-1808-6. Epub 2017 Nov 10.
PubMed 29127483Cardon E, Jacquemin L, Schecklmann M, Langguth B, Mertens G, Vanderveken OM, Lammers M, Van de Heyning P, Van Rompaey V, Gilles A. Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study. Ear Hear. 2022 Nov-Dec 01;43(6):1816-1823. doi: 10.1097/AUD.0000000000001246. Epub 2022 Jun 7.
PubMed 35666538
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study
- ClinicalTrials.gov ID
- NCT04565132
- Acronym / sponsor ID
- HDtDCS_extensive
- Conditions
- Tinnitus, Subjective
- Keywords
- tinnitus, neuromodulation, non-invasive brain stimulation, transcranial direct current stimulation, large cohort, high-definition tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 25 Sep 2020 (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.
Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS | Experimental | Device: High Definition transcranial Direct Current StimulationEach patient received a total of six sessions of anodal HD-tDCS of right DLPFC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic, subjective, non-pulsatile tinnitus
- met the criteria for HD-tDCS safety
Key exclusion criteria (2 listed)
- a middle ear pathology
- another tinnitus treatment ongoing
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 |
|---|---|---|
| High Definition transcranial Direct Current Stimulation1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY) | Device | HD-tDCS |
Primary outcome
Change in Tinnitus Functional Index (TFI)
Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus
4 secondary outcomes
Change in Visual Analogue scale (VAS) for tinnitus loudness
Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Tinnitus Questionnaire (TQ)
Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hyperacusis Questionnaire (HQ)
Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
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 25 Sep 2020.
- Background: PubMed 30019630Jacquemin L, Shekhawat GS, Van de Heyning P, Mertens G, Fransen E, Van Rompaey V, Topsakal V, Moyaert J, Beyers J, Gilles A. Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. Neurorehabil Neural Repair. 2018 Aug;32(8):714-723. doi: 10.1177/1545968318787916. Epub 2018 Jul 18.
- Background: PubMed 26180052Shekhawat GS, Sundram F, Bikson M, Truong D, De Ridder D, Stinear CM, Welch D, Searchfield GD. Intensity, Duration, and Location of High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief. Neurorehabil Neural Repair. 2016 May;30(4):349-59. doi: 10.1177/1545968315595286. Epub 2015 Jul 15.
- Background: PubMed 29127483Shekhawat GS, Vanneste S. High-definition transcranial direct current stimulation of the dorsolateral prefrontal cortex for tinnitus modulation: a preliminary trial. J Neural Transm (Vienna). 2018 Feb;125(2):163-171. doi: 10.1007/s00702-017-1808-6. Epub 2017 Nov 10.
- Derived from this study: PubMed 35666538Cardon E, Jacquemin L, Schecklmann M, Langguth B, Mertens G, Vanderveken OM, Lammers M, Van de Heyning P, Van Rompaey V, Gilles A. Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study. Ear Hear. 2022 Nov-Dec 01;43(6):1816-1823. doi: 10.1097/AUD.0000000000001246. Epub 2022 Jun 7.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High Definition transcranial Direct Current Stimulation in people with Tinnitus, Subjective, run by University Hospital, Antwerp.
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 2 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in Tinnitus Functional Index (TFI) (time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up). 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 NCT04565132, which also lists 4 linked publications.
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 25 Sep 2020.