Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia, Attention Deficit Hyperactivity Disorder and Bipolar Disorder
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 2013 |
| Estimated Primary Completion Date: | July 2013 (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 |
Patients recruited from the University Hospital of North Norway and the General Practice Clinic in Balsfjord, Troms, Norway. Healthy controls from North Norway.
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| Contact: Viktor Wahlström, MD | +47 77722147 | medicinare@hotmail.com |
| Contact: Rolf Wynn | rolf.wynn@gmail.com |
| 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. | |
| 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: | September 4, 2012 |
| 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:
|
Bipolar Disorder Schizophrenia Attention Deficit Disorder with Hyperactivity Hyperkinesis Affective Disorders, Psychotic Mood Disorders Mental Disorders |
Schizophrenia and Disorders with Psychotic Features Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013