Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
NCT ID: NCT01629355
Last Updated: 2015-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2012-07-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosed since at least one year prior to enrollment.
Exclusion Criteria
* Severe ongoing alcohol abuse or drug abuse
* Diagnosed psychiatric comorbidity
* Brain injury following cranial trauma
18 Years
70 Years
ALL
Yes
Sponsors
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SensoDetect
INDUSTRY
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Rolf Wynn, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Locations
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Balsfjord Legekontor
Balsfjord, Troms, Norway
University Hospital North Norway
Tromsø, Troms, Norway
Countries
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References
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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.
Related Links
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Abnormal auditory forward masking pattern in the brainstem response of individuals with Asperger syndrome
The Role of Psychoacoustics for the Research on Neuropsychiatric states
Aberrant brain stem functioning in schizophrenia
Other Identifiers
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2011/2149 (REK)
Identifier Type: -
Identifier Source: org_study_id
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