Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01629355
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2012-06-06
Brief Title:
Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ABRSD-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 n5 patients with diagnosed ADHD schizophrenia and bipolar disorder and to compare these patients n15 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 n24 are compared to each other and to healthy controls n12 in order to evaluate the method as a diagnostic tool in clinical healthcare practice
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 ABRSD-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 n5 patients with diagnosed ADHD schizophrenia and bipolar disorder and to compare these patients n15 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 n24 are compared to each other and to healthy controls n12 in order to evaluate the method as a diagnostic tool in clinical healthcare practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None