Bipolar DisorderNCT01629355
Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
An observational study of Bipolar Disorder and Schizophrenia, run by University Hospital of North Norway at 2 sites in Norway.
Trial summary
The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Attention Deficit Disorder With Hyperactivity
- How many people
- 66 participants
- Where
- 2 sitesNorway
- Study dates
- Jul 2012to Aug 2015
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients recruited from the University Hospital of North Norway and the General Practice Clinic in Balsfjord, Troms, Norway. Healthy controls from North Norway.
Who may be able to join
- Best-practise diagnosed schizophrenia, bipolar disorder or ADHD
- Diagnosed since at least one year prior to enrollment.
Who cannot join
- Serious hearing loss
- Severe ongoing alcohol abuse or drug abuse
- Diagnosed psychiatric comorbidity
- Brain injury following cranial trauma
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Balsfjord Legekontor
Balsfjord, Troms
University Hospital North Norway
Tromsø, Troms, 9009
About this study
The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder.
Read the detailed description
Background:
Within the daily clinical work of all medical specialties, objective diagnostic tools are paramount. However, in the psychiatric field such measures are lacking. Since 1983 the method of psychoacoustics has been under development in hope to serve this purpose. A recent development of auditory brainstem response (ABR/SD-BERA), has been proposed as a potential diagnostic tool within psychiatry.
The ABR is a diagnostic tool used primarily to diagnose sensorineural hearing loss. It detects evoked potentials, generated by neuronal activity in the auditory pathways in the brainstem, within the first 10 ms following acoustic stimulation. The potentials are recorded by surface electrodes placed on the forehead and on the mastoid processes. The wave pattern recorded consists of seven peaks, which are interpreted with respect to latencies and amplitudes.
Previous studies have aimed to associate the peaks with specific anatomical structures. The method SD-BERA is a further development of the standard ABR. It uses a wider array of acoustic stimuli, including complex sounds, for instance masking noises. The measuring procedure will roughly take 25 minutes. Previous studies using these complex sounds to compare mentally healthy subjects with patients suffering from schizophrenia, ADHD and bipolar disorder have shown that the different psychiatric groups exhibit specific wave patterns.
Aims
The aim of the first study is to validate previous results and identify five (n=5) patients with diagnosed ADHD, schizophrenia and bipolar disorder, and to compare these patients (n=15) with healthy, age-matched controls.
The aim of the second study is to present a blinded study where 12 patients with schizophrenia and 12 patients with bipolar disorder (total n=24) are compared to each other and to healthy controls (n=12) in order to evaluate the method as a diagnostic tool in clinical healthcare practice.
- Keywords
- Auditory Brainstem Response, ABR, SD-BERA
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Five patients with diagnosed schizophrenia will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with schizophrenia will then be studied blindly to evaluate the predictive value of the test. | |
| ADHD | Five patients with diagnosed ADHD will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. | |
| Bipolar disorder | Five patients with diagnosed Bipolar disorder will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with Bipolar disorder will then be studied blindly to evaluate the predictive value of the test. | |
| Healthy controls | Fifteen healthy controls will be used to define normal pattern of ABR/SD-BERA potentials. Another twelve normal controls will be studied blindly to evaluate the predictive value of the test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SD-BERA patterns identified by SensoDetect using specific software
The Auditory Brainstem Response examination (SD-BERA) will be conducted once for each patient following his/her inclusion in the study
Measured: Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- SensoDetect
- Responsible party
- Sponsor
- Investigators
- Rolf Wynn, M.D., Ph.D., Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629355
- Sponsor's protocol ID
- 2011/2149 (REK)
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wahlstrom V, Ahlander F, Wynn R. Auditory brainstem response as a diagnostic tool for patients suffering from schizophrenia, attention deficit hyperactivity disorder, and bipolar disorder: protocol. JMIR Res Protoc. 2015 Feb 12;4(1):e16. doi: 10.2196/resprot.3880.
PubMed 25679914
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01629355
- Acronym / sponsor ID
- 2011/2149 (REK)
- Keywords
- Auditory Brainstem Response, ABR, SD-BERA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- SensoDetect
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jun 2012 (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 purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder.
Detailed description
Background:
Within the daily clinical work of all medical specialties, objective diagnostic tools are paramount. However, in the psychiatric field such measures are lacking. Since 1983 the method of psychoacoustics has been under development in hope to serve this purpose. A recent development of auditory brainstem response (ABR/SD-BERA), has been proposed as a potential diagnostic tool within psychiatry.
The ABR is a diagnostic tool used primarily to diagnose sensorineural hearing loss. It detects evoked potentials, generated by neuronal activity in the auditory pathways in the brainstem, within the first 10 ms following acoustic stimulation. The potentials are recorded by surface electrodes placed on the forehead and on the mastoid processes. The wave pattern recorded consists of seven peaks, which are interpreted with respect to latencies and amplitudes.
Previous studies have aimed to associate the peaks with specific anatomical structures. The method SD-BERA is a further development of the standard ABR. It uses a wider array of acoustic stimuli, including complex sounds, for instance masking noises. The measuring procedure will roughly take 25 minutes. Previous studies using these complex sounds to compare mentally healthy subjects with patients suffering from schizophrenia, ADHD and bipolar disorder have shown that the different psychiatric groups exhibit specific wave patterns.
Aims
The aim of the first study is to validate previous results and identify five (n=5) patients with diagnosed ADHD, schizophrenia and bipolar disorder, and to compare these patients (n=15) with healthy, age-matched controls.
The aim of the second study is to present a blinded study where 12 patients with schizophrenia and 12 patients with bipolar disorder (total n=24) are compared to each other and to healthy controls (n=12) in order to evaluate the method as a diagnostic tool in clinical healthcare practice.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | –Five patients with diagnosed schizophrenia will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with schizophrenia will then be studied blindly to evaluate the predictive value of the test. |
| ADHD | – | –Five patients with diagnosed ADHD will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. |
| Bipolar disorder | – | –Five patients with diagnosed Bipolar disorder will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with Bipolar disorder will then be studied blindly to evaluate the predictive value of the test. |
| Healthy controls | – | –Fifteen healthy controls will be used to define normal pattern of ABR/SD-BERA potentials. Another twelve normal controls will be studied blindly to evaluate the predictive value of the test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from the University Hospital of North Norway and the General Practice Clinic in Balsfjord, Troms, Norway. Healthy controls from North Norway.
Key inclusion criteria (2 listed)
- Best-practise diagnosed schizophrenia, bipolar disorder or ADHD
- Diagnosed since at least one year prior to enrollment.
Key exclusion criteria (4 listed)
- Serious hearing loss
- Severe ongoing alcohol abuse or drug abuse
- Diagnosed psychiatric comorbidity
- Brain injury following cranial trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SD-BERA patterns identified by SensoDetect using specific software
Time frame: Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination
The Auditory Brainstem Response examination (SD-BERA) will be conducted once for each patient following his/her inclusion in the study
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 1 Sep 2015.
- Derived from this study: PubMed 25679914Wahlstrom V, Ahlander F, Wynn R. Auditory brainstem response as a diagnostic tool for patients suffering from schizophrenia, attention deficit hyperactivity disorder, and bipolar disorder: protocol. JMIR Res Protoc. 2015 Feb 12;4(1):e16. doi: 10.2196/resprot.3880.
- Abnormal auditory forward masking pattern in the brainstem response of individuals with Asperger syndromeLink provided by the sponsor.
- The Role of Psychoacoustics for the Research on Neuropsychiatric statesLink provided by the sponsor.
- Aberrant brain stem functioning in schizophreniaLink provided by the sponsor.
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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.
Rolf Wynn, M.D., Ph.D. principal investigator
University Hospital of North Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Schizophrenia, run by University Hospital of North Norway at 2 sites in Norway.
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 4 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 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. 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?
SD-BERA patterns identified by SensoDetect using specific software (time frame: Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination). 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 NCT01629355, which also lists 1 linked publication.
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 1 Sep 2015.