TinnitusNCT02648542
The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
A study testing Compensatory auditory stimulation, transcranial direct current stimulation and Combined CAS and tDCS in people with Tinnitus, run by Soterix Medical.
Trial summary
This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Compensatory auditory stimulation, transcranial direct current stimulation and Combined CAS and tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jul 2014
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-80 years of age
- No history of otological disease
- Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate
Who cannot join
- hearing loss greater than 50 dB HL
- Shows signs of depression or anxiety (Zung self-rating Depression Scale > 50; Beck Anxiety Inventory > 36)
About this study
This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment.
Read the detailed description
Tinnitus refers to persistent "ringing in the ears" in absence of external sound. For some individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. Existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. Newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. While these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient.
Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). For tinnitus however this treatment modality has only been tested in isolation. The purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tDCS.
There is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing loss. Our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. In this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.This is consistent with the reported benefits of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.
- Conditions
- Tinnitus
- Being tested
- Compensatory auditory stimulation, transcranial direct current stimulation, Combined CAS and tDCS, Sham stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory auditory stimulationOther
Also called CAS
Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.
transcranial direct current stimulationDevice
Also called tDCS
Low-current electrical brain stimulation
Combined CAS and tDCSOther
Also called CAS + tDCS
Combined auditory and electrical stimulation
Sham stimulationOther
Also called Sham
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| CAS vs. tDCS | Active comparator | Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS) Receives: Other: Compensatory auditory stimulation; Device: transcranial direct current stimulation |
| Combined CAS+tDCS vs. Sham | Sham comparator | Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation Receives: Other: Combined CAS and tDCS; Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in minimum masking levels
Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.
Measured: 2 weeks
Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness
Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucas C Parra, Ph.D., Principal investigator, City College of New York, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648542
- Sponsor's protocol ID
- CASTDCS001
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2015
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be shared if requested
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
- ClinicalTrials.gov ID
- NCT02648542
- Acronym / sponsor ID
- CASTDCS001
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment.
Detailed description
Tinnitus refers to persistent "ringing in the ears" in absence of external sound. For some individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. Existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. Newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. While these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient.
Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). For tinnitus however this treatment modality has only been tested in isolation. The purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tDCS.
There is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing loss. Our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. In this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.This is consistent with the reported benefits of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAS vs. tDCS | Active comparator | Other: Compensatory auditory stimulation, Device: transcranial direct current stimulationAssess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS) |
| Combined CAS+tDCS vs. Sham | Sham comparator | Other: Combined CAS and tDCS, Other: Sham stimulationAssess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-80 years of age
- No history of otological disease
- Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate
Key exclusion criteria (2 listed)
- hearing loss greater than 50 dB HL
- Shows signs of depression or anxiety (Zung self-rating Depression Scale > 50; Beck Anxiety Inventory > 36)
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 |
|---|---|---|
| Compensatory auditory stimulationAlso: CASCompensating for peripheral hearing loss by adjusting sound levels based on individual audiogram. | Other | CAS vs. tDCS |
| transcranial direct current stimulationAlso: tDCSLow-current electrical brain stimulation | Device | CAS vs. tDCS |
| Combined CAS and tDCSAlso: CAS + tDCSCombined auditory and electrical stimulation | Other | Combined CAS+tDCS vs. Sham |
| Sham stimulationAlso: ShamSham stimulation | Other | Combined CAS+tDCS vs. Sham |
Primary outcome
Reduction in minimum masking levels
Time frame: 2 weeks
Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.
Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness
Time frame: 2 weeks
Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.
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 19 Dec 2024.
- Individual participant dataSharing planned: Yes. De-identified data will be shared if requested
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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.
Lucas C Parra, Ph.D. principal investigator
City College of New York, CUNY
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory auditory stimulation, transcranial direct current stimulation and Combined CAS and tDCS in people with Tinnitus, run by Soterix Medical.
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 3 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 19 Dec 2024. 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. 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?
Reduction in minimum masking levels (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.