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Clinical Trials/NCT01629355
NCT01629355
Completed
Not Applicable

Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder

University Hospital of North Norway2 sites in 1 country66 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
University Hospital of North Norway
Enrollment
66
Locations
2
Primary Endpoint
SD-BERA patterns identified by SensoDetect using specific software
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
August 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Study Sites (2)

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