Trial of Stimulus-response Potentiation in Schizophrenia

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Cairo University (CU)

Status

Completed

Conditions

Schizophrenia

Treatments

Diagnostic Test: Auditory High Frequency Tetanizing Stimulation
Diagnostic Test: Sham Comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT03892876
N-173-2019

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For Schizophrenia group:

Inclusion Criteria:

  • Able to give written informed consent
  • Males (ages 20-50 years)
  • Diagnosis of schizophrenia as confirmed by Structured Clinical Interview for DSM-V-TR (SCID)
  • on stable doses of antipsychotic medications for at least 15 days
  • scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.

Exclusion Criteria:

  • History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
  • Any type of hearing deficit will be excluded by audiometry assessment
  • Substance abuse in the past 2 months
  • medical conditions that make it difficult for the patient to visit the clinic in the designed schedule.

For control group:

Inclusion criteria:

  • able to give written informed consent
  • males (ages 20-50).

Exclusion criteria:

  • History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
  • Any type of hearing deficit
  • if they meet any axis-I diagnosis according to DSM-V confirmed by SCID.
  • scores 2 or more on one item of the Positive and Negative Syndrome Scale

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

Schizophrenia TS+ve
Experimental group
Description:
Schizophrenia patients who receive auditory high frequency Tetanizing Stimulation
Treatment:
Diagnostic Test: Auditory High Frequency Tetanizing Stimulation
Schizophrenia TS-ve
Sham Comparator group
Description:
Schizophrenia patients who receive sham comparator
Treatment:
Diagnostic Test: Sham Comparator
Control TS+ve
Experimental group
Description:
Healthy controls who receive auditory high frequency Tetanizing Stimulation
Treatment:
Diagnostic Test: Auditory High Frequency Tetanizing Stimulation
Control TS-ve
Sham Comparator group
Description:
Healthy controls who receive sham comparator
Treatment:
Diagnostic Test: Sham Comparator

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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