Clinical trial NCT01629355: Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Official title: Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Attention Deficit Disorder With Hyperactivity
Keywords: Auditory Brainstem Response
ABR
SD-BERA
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: SensoDetect
First posted: 2012-06-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Best-practise diagnosed schizophrenia, bipolar disorder or ADHD
* Diagnosed since at least one year prior to enrollment.

Exclusion Criteria:

* Serious hearing loss
* Severe ongoing alcohol abuse or drug abuse
* Diagnosed psychiatric comorbidity
* Brain injury following cranial trauma

Primary outcomes:
measure: SD-BERA patterns identified by SensoDetect using specific software
timeFrame: Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination
Secondary outcomes:
Other outcomes:
Locations:
city: Balsfjord
country: Norway
facility: Balsfjord Legekontor
state: Troms
city: Tromsø
country: Norway
facility: University Hospital North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Rolf Wynn, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.