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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629355
• Other study ID #: 2011/2149 (REK)
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: August 31, 2015
• Start date: July 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Bipolar Disorder
• Disease
• Schizophrenia

Locations

Country	Name	City	State
Norway	Balsfjord Legekontor	Balsfjord	Troms
Norway	University Hospital North Norway	Tromsø	Troms

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	SensoDetect

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SD-BERA patterns identified by SensoDetect using specific software	The Auditory Brainstem Response examination (SD-BERA) will be conducted once for each patient following his/her inclusion in the study	Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination	No

External Links

•   Aberrant brain stem functioning in schizophrenia
•   Abnormal auditory forward masking pattern in the brainstem response of individuals with Asperger syndrome
•   The Role of Psychoacoustics for the Research on Neuropsychiatric states