NCT03892876

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

March 25, 2019

Last Update Submit

June 29, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • N100 wave (AEP) amplitude in µv [microvolts]

    N100 or N1 is a large, negative-going evoked potential measured by electroencephalography. It peaks in adults between 80 and 120 milliseconds after the onset of a stimulus, and distributed mostly over the fronto-central region of the scalp.

    1-2 hours

  • P300 wave amplitude in µv [microvolts] (auditory odd-ball task)

    The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. It is considered to be an endogenous potential, as its occurrence links not to the physical attributes of a stimulus, but to a person's reaction to it. More specifically, the P300 is thought to reflect processes involved in stimulus evaluation or categorization.

    1-2 hours

Secondary Outcomes (1)

  • performance of Wisconsin Card Sorting test (WCST).

    3 days

Study Arms (4)

Schizophrenia TS+ve

EXPERIMENTAL

Schizophrenia patients who receive auditory high frequency Tetanizing Stimulation

Diagnostic Test: Auditory High Frequency Tetanizing Stimulation

Schizophrenia TS-ve

SHAM COMPARATOR

Schizophrenia patients who receive sham comparator

Diagnostic Test: Sham Comparator

Control TS+ve

EXPERIMENTAL

Healthy controls who receive auditory high frequency Tetanizing Stimulation

Diagnostic Test: Auditory High Frequency Tetanizing Stimulation

Control TS-ve

SHAM COMPARATOR

Healthy controls who receive sham comparator

Diagnostic Test: Sham Comparator

Interventions

Auditory High Frequency Tetanizing StimulationDIAGNOSTIC_TEST

50 ms tone pips presented at high frequency for 120 seconds

Control TS+veSchizophrenia TS+ve
Sham ComparatorDIAGNOSTIC_TEST

auditory tone pips with interstimulus interval (ISI) 1 sec

Control TS-veSchizophrenia TS-ve

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry-Faculty of medicine-University of Cairo

Cairo, Cairo Governerate, 11562, Egypt

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ola O Shahin, MD

    Department of Psychiatry-University of Cairo

    STUDY DIRECTOR

  • Vishwajit L Nimgaonkar, PhD

    Department of Psychiatry-University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Psychiatry

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

September 1, 2019

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

EG(1)