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

NCT01629355 | Completed

• 1 other identifier: 2011/2149 (REK)
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Disorder; Schizophrenia; Attention Deficit Disorder With Hyperactivity

Keywords

Auditory Brainstem Response; ABR; SD-BERA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Best-practise diagnosed schizophrenia, bipolar disorder or ADHD
• Diagnosed since at least one year prior to enrollment.

You may not qualify if:

• Serious hearing loss
• Severe ongoing alcohol abuse or drug abuse
• Diagnosed psychiatric comorbidity
• Brain injury following cranial trauma

Sponsors & Collaborators

• University Hospital of North Norway: lead
• SensoDetect: collaborator

Study Sites (2)

Balsfjord Legekontor

Balsfjord, Troms, Norway

Location

University Hospital North Norway

Tromsø, Troms, 9009, Norway

Location

Related Publications (1)

• 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.

  PMID: 25679914 DERIVED

Related 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

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Rolf Wynn, M.D., Ph.D.

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 27, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

NO (2)