Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03892876 |
Other study ID # |
N-173-2019 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
April 15, 2021 |
Study information
Verified date |
June 2021 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This clinical trial aims at examining the effects of auditory high-frequency stimulation in
schizophrenia patient, aiming to increase their AEPs, which are known to be attenuated from
previous literature
Description:
Schizophrenia is a chronic psychiatric disorder with a lifetime prevalence of 4.0 per 1,000.
The introduction of antipsychotic medications in the 1950s resulted in marked clinical
improvement in the symptom profile of schizophrenia, nevertheless the disease still
contributes to a significant proportion of global disease burden in terms of both morbidity
and mortality. In this regard, cognitive deficits and residual negative symptoms are
considered major contributing factors to psychosocial disability and poor functional outcome
associated with the disorder.
Higher-order cognitive functions; e.g. working memory and executive functions; show variable
deficits and are considered a core clinical symptom of schizophrenia. On the other hand, the
disorder is also characterized by abnormalities at the basic level of primary sensory
processing, i.e. auditory, visual and somatosensory processing. Such abnormalities in the
primary process of sensory perception could change the sensory experiences of schizophrenia
patients and thus contribute to the psychopathology.
Event-related potentials (ERPs) are the neurophysiological correlates of sensory processing.
ERP abnormalities have been widely described in schizophrenia literature: Pre-pulse
inhibition of startle (PPI) in which a weaker pre-stimulus (pre-pulse) inhibits the reaction
to a subsequent strong startling stimulus (pulse) is impaired in schizophrenia. P50
suppression, a measure of sensory gating, is also often absent or reduced in the disorder.
N100; a measure of basic auditory sensory perception; shows significant amplitude reduction
in patients compared to controls. Mismatch negativity (MMN), a measure of automatic deviance
detection and shows characteristic attenuation in schizophrenia. P300, which is involved in
higher-level stimulus evaluation and categorization, also shows abnormalities along the
disease course.
In the study by Clapp et al., 2005, auditory high frequency stimulation (tetanizing
stimulation) resulted in an increase in auditory-evoked potentials (AEPs) in healthy
individuals; i.e. an increase in N1 amplitude that persisted even after stimulation. This
augmentation of N1 amplitude was regarded as a result of plastic synaptic potentiation
similar to long-term potentiation (LTP) described after electrical tetanic stimulation in
cellular studies. Similar findings were later replicated by Lei et al., 2017, where they used
pure tones, narrow band noises and white noise to induce stable potentiation and augmentation
of N1 amplitude.