TinnitusPhase 2NCT02053961
Deep TMS of the Left Auditory Cortex Using the HMCIPCC Coil, in the Treatment of Patients With Tinnitus.
A Phase 2 study testing Deep Transcranial Magnetic Stimulation in people with Tinnitus, run by Brainsway at 1 site in Israel.
Trial summary
The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Deep Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 20-70.
- Self-report of tinnitus in one or both ears, persisting for over a year, with no other hearing impairment.
- Mild/moderate/severe tinnitus. Severity of tinnitus will be diagnosed using the TQ (Goebel \& Hiller) / the THI (Newman \& Jacobson).
- Unresponsive to standard tinnitus medication.
- Normal results on pure tone audiometry testing (threshold ≤ 25 dB hearing level in all frequencies from 250 to 8000 Hz).
- Normal middle ear status was demonstrated by tympanometry, stapedius reflex tests, and otoscopy.
- Normal results on neurological and physiological examinations.
- Gave their oral and written consent to participate in the trial.
Who cannot join
- A DSM-IV Axis-I psychiatric disorder.
- Use of medication that may be a risk factor for seizures, such as:
- antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
- History of intolerance to TMS.
- Diagnosis of a severe personality disorder according to the DSM-IV.
- Current suicidal ideation.
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- Uncontrolled hypertension.
- History of epilepsy, seizure, or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
- History of head injury or stroke.
- History of any metallic particles in the head (except dental fillings).
- History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemakers, cochlear implants, use of neurostimulators, or any medical pumps.
- History of drug or alcohol abuse.
- Inability to communicate adequately with examiner.
- Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
- Inability to sign a consent form.
- Pregnancy or inadequate birth control.
- Severe hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of dTMS Among Patient Who Suffer From Tinnitus
The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus
Read the detailed description
Stages of the study:
- Patient recruitment stage: hearing tests battery including: otoscopy, tympanometry, pure-tone audiometry - 0 to 20 dB HL; 21 to 60 dB HL and more than 60 dB HL, tinnitus matching, TQ and VAS.
- Patients will be assign to one of two study groups, Deep TMS over the left auditory cortex and Sham. .
- TMS Acute treatment phase:
TMS treatment will be administer for two weeks: 5 days a week for half an hour. Before each TMS treatment session, patients will undergo training exercises designed to stimulate the neural network associated with attention processes Monitoring for evaluation of treatment efficacy and side effects will be perform on a daily basis. . The overall time of each session is estimate to be 1 hour.
- TMS Maintenance phase:
Four additional TMS treatment sessions will be administered once weekly for another 4 weeks.
Long-term durability of treatment effect will be assessed up to 90 days after the last TMS session.
- TMS treatment program:
- The subject will be required to use earplugs to minimize risk of hearing impairment.
- Motor threshold stimulation intensity will be determined prior to each TMS session. .
- Subjects will receive either active TMS or sham treatment, depending on the experimental group to which they were assign. During the first 2 weeks, five treatment sessions will be administer each week. During the following 4 weeks, one treatment will be administer weekly. Overall, each subject will receive 16 TMS session in 6 treatment weeks.
- Safety:
Throughout the trial subjects will be constantly monitored by a physician. Any adverse effect or subjective discomfort experienced will be documented and addressed.
Magnetic stimulation treatment will be administered by an operator trained and certified by Brainsway.
Subjects who wish to withdraw from the study will be free to do so at any point.
Drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan).
- Conditions
- Tinnitus
- Being tested
- Deep Transcranial Magnetic Stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Transcranial Magnetic StimulationDevice
1Hz dTMS real treatment
Deep Transcranial Magnetic StimulationDevice
1Hz dTMS SHAM treatment
| Study group | Role | What they receive |
|---|---|---|
| 1Hz dTMS Real | Active comparator | This group will receive dTMS real treatment of 1Hz Receives: Device: Deep Transcranial Magnetic Stimulation |
| 1HZ dTMS SHAM | Sham comparator | This group will receive 1HZ dTMS SHAM treatment Receives: Device: Deep Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
TQ - Tinnitus questionnaire
Measured: 90 days after the last treatment session
Secondary outcomes (1)
VAS (100 - worst possible tinnitus related discomfort; 0 - wellness)
Measured: baseline, week 1: day 1-5, and week 2: day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2014 (estimated)
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yair Lampel, Prof., Principal investigator, Neurology Department, Wolfson Hospital, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053961
- Sponsor's protocol ID
- dTMS-Tinnitus- wolfson
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of dTMS Among Patient Who Suffer From Tinnitus
- ClinicalTrials.gov ID
- NCT02053961
- Acronym / sponsor ID
- dTMS-Tinnitus- wolfson
- Conditions
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (estimated)
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 4 Feb 2014 (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.
The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus
Detailed description
Stages of the study:
- Patient recruitment stage: hearing tests battery including: otoscopy, tympanometry, pure-tone audiometry - 0 to 20 dB HL; 21 to 60 dB HL and more than 60 dB HL, tinnitus matching, TQ and VAS.
- Patients will be assign to one of two study groups, Deep TMS over the left auditory cortex and Sham. .
- TMS Acute treatment phase:
TMS treatment will be administer for two weeks: 5 days a week for half an hour. Before each TMS treatment session, patients will undergo training exercises designed to stimulate the neural network associated with attention processes Monitoring for evaluation of treatment efficacy and side effects will be perform on a daily basis. . The overall time of each session is estimate to be 1 hour.
- TMS Maintenance phase:
Four additional TMS treatment sessions will be administered once weekly for another 4 weeks.
Long-term durability of treatment effect will be assessed up to 90 days after the last TMS session.
- TMS treatment program:
- The subject will be required to use earplugs to minimize risk of hearing impairment.
- Motor threshold stimulation intensity will be determined prior to each TMS session. .
- Subjects will receive either active TMS or sham treatment, depending on the experimental group to which they were assign. During the first 2 weeks, five treatment sessions will be administer each week. During the following 4 weeks, one treatment will be administer weekly. Overall, each subject will receive 16 TMS session in 6 treatment weeks.
- Safety:
Throughout the trial subjects will be constantly monitored by a physician. Any adverse effect or subjective discomfort experienced will be documented and addressed.
Magnetic stimulation treatment will be administered by an operator trained and certified by Brainsway.
Subjects who wish to withdraw from the study will be free to do so at any point.
Drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Hz dTMS Real | Active comparator | Device: Deep Transcranial Magnetic StimulationThis group will receive dTMS real treatment of 1Hz |
| 1HZ dTMS SHAM | Sham comparator | Device: Deep Transcranial Magnetic StimulationThis group will receive 1HZ dTMS SHAM treatment |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 20-70.
- Self-report of tinnitus in one or both ears, persisting for over a year, with no other hearing impairment.
- Mild/moderate/severe tinnitus. Severity of tinnitus will be diagnosed using the TQ (Goebel \& Hiller) / the THI (Newman \& Jacobson).
- Unresponsive to standard tinnitus medication.
- Normal results on pure tone audiometry testing (threshold ≤ 25 dB hearing level in all frequencies from 250 to 8000 Hz).
Key exclusion criteria (18 listed)
- A DSM-IV Axis-I psychiatric disorder.
- Use of medication that may be a risk factor for seizures, such as:
- antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
- History of intolerance to TMS.
- Diagnosis of a severe personality disorder according to the DSM-IV.
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 |
|---|---|---|
| Deep Transcranial Magnetic Stimulation1Hz dTMS real treatment | Device | 1HZ dTMS SHAM, 1Hz dTMS Real |
| Deep Transcranial Magnetic Stimulation1Hz dTMS SHAM treatment | Device | 1HZ dTMS SHAM |
Primary outcome
TQ - Tinnitus questionnaire
Time frame: 90 days after the last treatment session
1 secondary outcome
VAS (100 - worst possible tinnitus related discomfort; 0 - wellness)
Time frame: baseline, week 1: day 1-5, and week 2: day 1-5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Yair Lampel, Prof. principal investigator
Neurology Department, Wolfson Hospital, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep Transcranial Magnetic Stimulation in people with Tinnitus, run by Brainsway at 1 site in Israel.
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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 25 Jan 2018. 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 Israel. 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
TQ - Tinnitus questionnaire (time frame: 90 days after the last treatment session). 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 25 Jan 2018.