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Trial record 2 of 6 for:    "Brainstem auditory evoked responses"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01629355
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : September 1, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bipolar Disorder Schizophrenia 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 Design

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Study Start Date : July 2012
Primary Completion Date : May 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629355


Locations
Norway
Balsfjord Legekontor
Balsfjord, Troms, Norway
University Hospital North Norway
Tromsø, Troms, Norway, 9009
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01629355     History of Changes
Other Study ID Numbers: 2011/2149 (REK)
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders