Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia, Attention Deficit Hyperactivity Disorder and Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital of North Norway
Sponsor:
Collaborator:
SensoDetect
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01629355
First received: June 6, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD) and bipolar disorder.


Condition
Bipolar Disorder
Schizophrenia
Attention Deficit Disorder With Hyperactivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia, ADHD and Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The Auditory Brainstem Response examination (SD-BERA) will be conducted once for each patient following his/her inclusion in the study


Estimated Enrollment: 78
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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. Twelve patients with ADHD will then be studied blindly to evaluate the predictive value of the test.
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.

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 respective diagnoses (total n=36) 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629355

Contacts
Contact: Viktor Wahlström, MD +47 77722147 medicinare@hotmail.com
Contact: Rolf Wynn rolf.wynn@gmail.com

Locations
Norway
Balsfjord Legekontor Recruiting
Balsfjord, Troms, Norway
Contact: Viktor Wahlstöm, M.D.    +47 77722147      
Principal Investigator: Rolf Wynn, M.D., Ph.D.         
University Hospital North Norway Recruiting
Tromsø, Troms, Norway, 9009
Contact: Viktor Wahlström, MD    +47 77722147      
Principal Investigator: Rolf Wynn, Prof.         
Sponsors and Collaborators
University Hospital of North Norway
SensoDetect
Investigators
Principal Investigator: Rolf Wynn, M.D., Ph.D. University Hospital of North Norway
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01629355     History of Changes
Other Study ID Numbers: 2011/2149 (REK)
Study First Received: June 6, 2012
Last Updated: October 9, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by University Hospital of North Norway:
Auditory Brainstem Response
ABR
SD-BERA

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Bipolar Disorder
Disease
Hyperkinesis
Schizophrenia
Affective Disorders, Psychotic
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014