Skip to main content
OpenTrials
Completed

NCT Number: NCT01629355

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Balsfjord Legekontor, Balsfjord, Troms, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • SensoDetect

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2012
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.