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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Attention Deficit Disorder With Hyperactivity

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Balsfjord, Troms, Norway
      • Balsfjord Legekontor
    • Tromsø, Troms, Norway, 9009
      • University Hospital North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Schizophrenia; 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.
ADHD; 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.
Bipolar disorder; 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.
Healthy controls; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: SensoDetect
• Investigators: Principal Investigator: Rolf Wynn, M.D., Ph.D., University Hospital of North Norway

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (ESTIMATE): June 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ABR; Auditory Brainstem Response; SD-BERA
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Schizophrenia; Disease; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2011/2149 (REK)