Chronic Tonal TinnitusPhase 1/2NCT00927121
Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
A Phase 1/2 study testing Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset in people with Chronic Tonal Tinnitus, run by ANM Adaptive Neuromodulation GmbH at 1 site in Germany.
Trial summary
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Tonal Tinnitus
- What is being tested?
- Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
- Mentally healthy people
- Chronic tonal Tinnitus
- Older than 18 years
- Signature of the patient informed consent
- No participation in other tinnitus therapy during the clinical investigation
Who cannot join
- A necessity for hearing aid
- Auditory hallucination
- Symptomatic hearing disorders
- "Morbus Meniere",
- Tinnitus due to temporomandibular joint disorders
- Subjects who can't perceive therapeutic tones
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- Brainstem diseases
- Psychiatric disorders
- Objective Tinnitus
- Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
Jülich, 8185
About this study
Official title: l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.
Trial objectives:
Read more
- The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
- To confirm the efficacy and safety of the coordinated reset technology.
These objectives will be assessed:
- By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.
- Conditions
- Chronic Tonal Tinnitus
- Being tested
- Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetDevice
The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity.
Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation.
The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : G_1 | Active comparator | G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence Receives: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset |
| Group 2 :G_2 | Active comparator | G_2: stimulation for 4 - 6 hours a day with 12-tone sequences Receives: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset |
| Group3 : G_3 | Active comparator | G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement Receives: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset |
| Group 4 : G_4 | Active comparator | G_4: stimulation for 1 hour a day, 4 tones per sequence Receives: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset |
| Group5 : G_5 | Placebo comparator | G_5: stimulation with placebo-tone Receives: Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Tonal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANM Adaptive Neuromodulation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927121
- Sponsor's protocol ID
- 09/1525
- Status last verified
- Apr 2012
- First submitted
- 22 Jun 2009
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C. Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restor Neurol Neurosci. 2012;30(2):137-59. doi: 10.3233/RNN-2012-110218.
PubMed 22414611Adamchic I, Langguth B, Hauptmann C, Tass PA. Psychometric evaluation of visual analog scale for the assessment of chronic tinnitus. Am J Audiol. 2012 Dec;21(2):215-25. doi: 10.1044/1059-0889(2012/12-0010). Epub 2012 Jul 30.
PubMed 22846637
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT00927121
- Acronym / sponsor ID
- 09/1525
- Conditions
- Chronic Tonal Tinnitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ANM Adaptive Neuromodulation GmbHIndustry (pharma, biotech, devices)
- First posted
- 24 Jun 2009 (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.
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.
Trial objectives:
- The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
- To confirm the efficacy and safety of the coordinated reset technology.
These objectives will be assessed:
- By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 : G_1 | Active comparator | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetG_1: stimulation for 4 - 6 hours a day, 4 tones per sequence |
| Group 2 :G_2 | Active comparator | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetG_2: stimulation for 4 - 6 hours a day with 12-tone sequences |
| Group3 : G_3 | Active comparator | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetG_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement |
| Group 4 : G_4 | Active comparator | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetG_4: stimulation for 1 hour a day, 4 tones per sequence |
| Group5 : G_5 | Placebo comparator | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetG_5: stimulation with placebo-tone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mentally healthy people
- Chronic tonal Tinnitus
- Older than 18 years
- Signature of the patient informed consent
- No participation in other tinnitus therapy during the clinical investigation
Key exclusion criteria (10 listed)
- A necessity for hearing aid
- Auditory hallucination
- Symptomatic hearing disorders
- "Morbus Meniere",
- Tinnitus due to temporomandibular joint 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 |
|---|---|---|
| Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated resetThe CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system | Device | Group 1 : G_1, Group 2 :G_2, Group 4 : G_4, Group3 : G_3, Group5 : G_5 |
Primary outcome
Not reported in the source record.
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 Apr 2012.
- Results publication: PubMed 22414611Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C. Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restor Neurol Neurosci. 2012;30(2):137-59. doi: 10.3233/RNN-2012-110218.
- Derived from this study: PubMed 22846637Adamchic I, Langguth B, Hauptmann C, Tass PA. Psychometric evaluation of visual analog scale for the assessment of chronic tinnitus. Am J Audiol. 2012 Dec;21(2):215-25. doi: 10.1044/1059-0889(2012/12-0010). Epub 2012 Jul 30.
Related trials for Chronic Tonal Tinnitus
Recruiting
Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
Tinnitus, Subjective, Tinnitus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset in people with Chronic Tonal Tinnitus, run by ANM Adaptive Neuromodulation GmbH at 1 site in Germany.
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 5 inclusion and 10 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 Apr 2012. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927121, which also lists 2 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 19 Apr 2012.