Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT01629355|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : September 1, 2015
|Condition or disease|
|Bipolar Disorder Schizophrenia Attention Deficit Disorder With Hyperactivity|
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.
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 Type :||Observational|
|Actual Enrollment :||66 participants|
|Observational Model:||Case Control|
|Official Title:||Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||August 2015|
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.
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.
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.
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629355
|Balsfjord, Troms, Norway|
|University Hospital North Norway|
|Tromsø, Troms, Norway, 9009|
|Principal Investigator:||Rolf Wynn, M.D., Ph.D.||University Hospital of North Norway|