Tinnitus, SubjectiveTDCSNCT04934371
Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Tinnitus, Subjective and Hyperacusis, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus, Subjective, Hyperacusis, Hearing Disorders
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 15 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tinnitus and or hyperacusis (> 8 months)
- adults (18-80 years old)
Who cannot join
- implanted metal or devices including cochlear implants,
- bullet wounds, head/neck tattoo,
- metal in the eyes,
- other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors),
- head trauma or brain surgery, psychiatric disorders,
- personal or family history of epilepsy, other seizure disorders
Show all 11Show fewer
- Individuals with a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, and
- chronic headaches.
- conductive hearing loss, or
- fluctuating hearing thresholds
- pure tone averages >70dB HL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona
Tucson, Arizona, 85721-0071
Aneta Kielar, PhD, 520-621-5105, akielar@email.arizona.edu
Barbara Cone, PhD, 520-626-3710 ext. Kielar, akielar@email.arizona.edu
About this study
Official title: Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study
The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions.
Read the detailed description
Tinnitus is characterized by the subjective perception of sound in the ears or in the brain without external stimulus. In about 30-50% of patients, tinnitus co-occurs with hyperacusis, which is abnormal sensitivity to sounds even at low levels. Chronic tinnitus and hyperacusis can be devastating since a significant proportion of sufferers develop sleep disturbances, psychiatric conditions, and a small fraction commit suicide. Tinnitus is often accompanied by difficulty concentrating and impairment on tasks that require sustained attention and executive control. Currently there is no satisfactory treatment for tinnitus and hyperacusis, contributing to patients' distress. Thus, there is an urgent need for interventions that would suppress the symptoms and possibly cure the disorder. Although, the pathophysiology of tinnitus and hyperacusis is not well understood, neurobiological research suggests that tinnitus and hyperacusis can be attributed to maladaptive neuroplasticity triggered by damage in the auditory system. Most symptoms of tinnitus have been attributed to the hyperactivity and reorganization in the auditory cortex (AC) and dorsolateral prefrontal brain regions (DLPFC). This suggests that electrical stimulation to the abnormally activated regions might modulate these overactive regions and reduce tinnitus and hyperacusis. TDCS is a noninvasive neurostimulation technique that uses weak electric currents (1-2 mA) applied to the scalp to modulate brain responsiveness by temporarily altering neuronal resting membrane potentials. It is proposed that this approach has a potential therapeutic value in treating tinnitus and hyperacusis.
Our proposed project examines whether application of tDCS to AC and DLPFC combined with active listening therapy serves to promote adaptive neuroplasticity and reduce subjective perception of sound and emotional distress.
The Aims are to: (1) Determine whether tDCS can lead to significant improvement in tinnitus and hyperacusis symptoms pre- versus post-stimulation and
(2) Examine electrophysiological responses and functional connectivity in the fronto-temporal-parietal network of brain regions in response to tDCS vs. sham.
The expected outcomes from this research will provide evidence to support the design and implementation of individualized tDCS protocols to potentiate treatment protocols that address the core deficits in tinnitus and hyperacusis. Our data will contribute to a more detailed understanding of the neurobiology of tinnitus and the mechanisms that contribute to the subjective, emotional and cognitive symptoms. The results of our study have a potential to develop effective treatment for the rehabilitation of tinnitus and contribute to the clinical practice.
Summary of study sequence and procedures:
Week 1: Baseline screening, hearing assessment, tinnitus assessment (2 hours), one magnetic resonance imaging (MRI) scan (45minutes), one electrophysiology recording (EEG-ERP)( 1 hour) Weeks 2-4: tDCS with active listening therapy Part 1
- 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy
Weeks 5 and 6: rest-period, post-treatment assessment, one MRI scan (45 min), one EEG-ERP session (1hour)
Weeks 7 to 9: tDCS with active listening therapy Part 2 (1 hour each sessions)
- 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy
Weeks 10 and 12: rest period and post-treatment assessment one MRI scan (45 min), one EEG-ERP session (1hour)
Week 18: 2-month follow-up, tinnitus assessment, one MRI scan (45 min), one EEG-ERP session (1 hour)
- Conditions
- Tinnitus, Subjective, Hyperacusis, Hearing Disorders
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham TDCS
- Medical subject headings
- Tinnitus, Hyperacusis, Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany)
TDCS is a procedure that sends weak electrical currents between points on the scalp. Some of this current flows through the brain, and may induce temporary changes in brain activity lasting 30-60 minutes beyond the time of stimulation. TDCS is believed to be very low risk. TDCS has been applied in more than 4900 studies and hundreds of people to treat various neurological and psychiatric conditions, including depression, epilepsy, chronic pain and Parkinson's. In this study we will use tDCS to suppress symptom of tinnitus and hyperacusis.
Sham TDCSDevice
Also called sham transcranial direct current simulation (tDCS)
Sham control will be administered to the same area as active TDCS
| Study group | Role | What they receive |
|---|---|---|
| active TDCS and listening therapy | Active comparator | TDCS will be administered with NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes at 2mA with a 15-s ramp-up and ramp-down period. Excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| sham TDCS and listening therapy | Sham comparator | The sham stimulation will also last for 20 min with 15 sec ramp-up and ramp-down, except the current will be turned down gradually to 0 milliamperes (mA) after 30 seconds. The sham procedure provides the same tingling and itching sensation felt during active tDCS. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS Receives: Device: Sham TDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)
change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)
Measured: through study completion, an average of 1 year
Mean change in the Sound Tolerance Questionnaire ratings
change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)
Measured: through study completion, an average of 1 year
mean change on the Tinnitus Functional Index (TFI) scores
change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)
Measured: through study completion, an average of 1 year
mean change on the Tinnitus Primary Function Questionnaire (TPFQ)
change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)
Measured: through study completion, an average of 1 year
Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale
participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
change in electrophysiological measures
change in mean latency and amplitude of the ERP responses (lower amplitude and increased latency indicate worse performance)
Measured: through study completion, an average of 1 year
change in functional connectivity measured with fMRI
changes in functional connectivity from pre to post intervention (increase or decrease possible)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 of ArizonaThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will undergo tDCS and active listening therapy. This will be double-blinded randomized-sham controlled intervention during which excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. After 2-month follow up participants will be crossed-over to the other treatment type. (Model AB- BA
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneta Kielar, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934371
- Sponsor's protocol ID
- 2105766514
- Acronym
- TDCS
- Status last verified
- May 2024
- First submitted
- 14 Jun 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58.
PubMed 20948722Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
PubMed 14645606Cardon E, Joossen I, Vermeersch H, Jacquemin L, Mertens G, Vanderveken OM, Topsakal V, Van de Heyning P, Van Rompaey V, Gilles A. Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020 Dec 17;15(12):e0243785. doi: 10.1371/journal.pone.0243785. eCollection 2020.
PubMed 33332414Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
PubMed 16427357Henry JA, Griest S, Zaugg TL, Thielman E, Kaelin C, Galvez G, Carlson KF. Tinnitus and hearing survey: a screening tool to differentiate bothersome tinnitus from hearing difficulties. Am J Audiol. 2015 Mar;24(1):66-77. doi: 10.1044/2014_AJA-14-0042.
PubMed 25551458
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT04934371
- Acronym / sponsor ID
- TDCS / 2105766514
- Conditions
- Tinnitus, Subjective, Hyperacusis, Hearing Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 22 Jun 2021 (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.
The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions.
Detailed description
Tinnitus is characterized by the subjective perception of sound in the ears or in the brain without external stimulus. In about 30-50% of patients, tinnitus co-occurs with hyperacusis, which is abnormal sensitivity to sounds even at low levels. Chronic tinnitus and hyperacusis can be devastating since a significant proportion of sufferers develop sleep disturbances, psychiatric conditions, and a small fraction commit suicide. Tinnitus is often accompanied by difficulty concentrating and impairment on tasks that require sustained attention and executive control. Currently there is no satisfactory treatment for tinnitus and hyperacusis, contributing to patients' distress. Thus, there is an urgent need for interventions that would suppress the symptoms and possibly cure the disorder. Although, the pathophysiology of tinnitus and hyperacusis is not well understood, neurobiological research suggests that tinnitus and hyperacusis can be attributed to maladaptive neuroplasticity triggered by damage in the auditory system. Most symptoms of tinnitus have been attributed to the hyperactivity and reorganization in the auditory cortex (AC) and dorsolateral prefrontal brain regions (DLPFC). This suggests that electrical stimulation to the abnormally activated regions might modulate these overactive regions and reduce tinnitus and hyperacusis. TDCS is a noninvasive neurostimulation technique that uses weak electric currents (1-2 mA) applied to the scalp to modulate brain responsiveness by temporarily altering neuronal resting membrane potentials. It is proposed that this approach has a potential therapeutic value in treating tinnitus and hyperacusis.
Our proposed project examines whether application of tDCS to AC and DLPFC combined with active listening therapy serves to promote adaptive neuroplasticity and reduce subjective perception of sound and emotional distress.
The Aims are to: (1) Determine whether tDCS can lead to significant improvement in tinnitus and hyperacusis symptoms pre- versus post-stimulation and
(2) Examine electrophysiological responses and functional connectivity in the fronto-temporal-parietal network of brain regions in response to tDCS vs. sham.
The expected outcomes from this research will provide evidence to support the design and implementation of individualized tDCS protocols to potentiate treatment protocols that address the core deficits in tinnitus and hyperacusis. Our data will contribute to a more detailed understanding of the neurobiology of tinnitus and the mechanisms that contribute to the subjective, emotional and cognitive symptoms. The results of our study have a potential to develop effective treatment for the rehabilitation of tinnitus and contribute to the clinical practice.
Summary of study sequence and procedures:
Week 1: Baseline screening, hearing assessment, tinnitus assessment (2 hours), one magnetic resonance imaging (MRI) scan (45minutes), one electrophysiology recording (EEG-ERP)( 1 hour) Weeks 2-4: tDCS with active listening therapy Part 1
- 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy
Weeks 5 and 6: rest-period, post-treatment assessment, one MRI scan (45 min), one EEG-ERP session (1hour)
Weeks 7 to 9: tDCS with active listening therapy Part 2 (1 hour each sessions)
- 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy
Weeks 10 and 12: rest period and post-treatment assessment one MRI scan (45 min), one EEG-ERP session (1hour)
Week 18: 2-month follow-up, tinnitus assessment, one MRI scan (45 min), one EEG-ERP session (1 hour)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each patient will undergo tDCS and active listening therapy. This will be double-blinded randomized-sham controlled intervention during which excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. After 2-month follow up participants will be crossed-over to the other treatment type. (Model AB- BA
| Arm | Type | Receives |
|---|---|---|
| active TDCS and listening therapy | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)TDCS will be administered with NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes at 2mA with a 15-s ramp-up and ramp-down period. Excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. |
| sham TDCS and listening therapy | Sham comparator | Device: Sham TDCSThe sham stimulation will also last for 20 min with 15 sec ramp-up and ramp-down, except the current will be turned down gradually to 0 milliamperes (mA) after 30 seconds. The sham procedure provides the same tingling and itching sensation felt during active tDCS. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic tinnitus and or hyperacusis (> 8 months)
- adults (18-80 years old)
Key exclusion criteria (11 listed)
- implanted metal or devices including cochlear implants,
- bullet wounds, head/neck tattoo,
- metal in the eyes,
- other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors),
- head trauma or brain surgery, psychiatric disorders,
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany)TDCS is a procedure that sends weak electrical currents between points on the scalp. Some of this current flows through the brain, and may induce temporary changes in brain activity lasting 30-60 minutes beyond the time of stimulation. TDCS is believed to be very low risk. TDCS has been applied in more than 4900 studies and hundreds of people to treat various neurological and psychiatric conditions, including depression, epilepsy, chronic pain and Parkinson's. In this study we will use tDCS to suppress symptom of tinnitus and hyperacusis. | Device | active TDCS and listening therapy |
| Sham TDCSAlso: sham transcranial direct current simulation (tDCS)Sham control will be administered to the same area as active TDCS | Device | sham TDCS and listening therapy |
Primary outcome
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)
Time frame: through study completion, an average of 1 year
change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)
Mean change in the Sound Tolerance Questionnaire ratings
Time frame: through study completion, an average of 1 year
change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)
mean change on the Tinnitus Functional Index (TFI) scores
Time frame: through study completion, an average of 1 year
change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)
mean change on the Tinnitus Primary Function Questionnaire (TPFQ)
Time frame: through study completion, an average of 1 year
change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)
Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale
Time frame: through study completion, an average of 1 year
participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment
2 secondary outcomes
change in electrophysiological measures
Time frame: through study completion, an average of 1 year
change in functional connectivity measured with fMRI
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 20948722Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58.
- Background: PubMed 14645606Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
- Background: PubMed 33332414Cardon E, Joossen I, Vermeersch H, Jacquemin L, Mertens G, Vanderveken OM, Topsakal V, Van de Heyning P, Van Rompaey V, Gilles A. Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020 Dec 17;15(12):e0243785. doi: 10.1371/journal.pone.0243785. eCollection 2020.
- Background: PubMed 16427357Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
- Background: PubMed 25551458Henry JA, Griest S, Zaugg TL, Thielman E, Kaelin C, Galvez G, Carlson KF. Tinnitus and hearing survey: a screening tool to differentiate bothersome tinnitus from hearing difficulties. Am J Audiol. 2015 Mar;24(1):66-77. doi: 10.1044/2014_AJA-14-0042.
- Individual participant dataSharing planned: No
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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.
Aneta Kielar, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Tinnitus, Subjective and Hyperacusis, run by University of Arizona at 1 site in United States.
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 11 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneta Kielar, PhD (520-621-5105, akielar@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS) (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 NCT04934371, which also lists 5 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 8 May 2024.