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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886417
Other study ID # 0906
Secondary ID 2009-A00248-49
Status Completed
Phase N/A
First received June 21, 2013
Last updated March 9, 2015
Start date October 2009
Est. completion date March 2015

Study information

Verified date March 2015
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in AVHs.

In order to examine whether AVHs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert AVHs (without articulation), overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and control subjects to detect any speech muscle activity during AVH.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Healthy controls:

- must be more than 18 years and less than 60 years old

- pre-inclusion medical examination

- must have signed consent form

- must be able to read stimuli on a screen

Schizophrenia patients:

- must be more than 18 years and less than 60 years old

- pre-inclusion medical examination

- must have signed consent form

- must be able to read stimuli on a screen

- diagnosed with a schizophrenia disorder according to DSM-IV TR (diagnostic and statistical of mental disorders) (PANSS item P3 greater than 4)

- prior evaluation of the secondary effects of any medication via Barnes and AIMS scales

- affiliated with the French social security

- if under guardianship, must have additional consent form signed by guardian

Exclusion Criteria:

Healthy controls:

- if aged less than 18 years or more than 60 years

- diagnosed with any psychiatric disorder

- with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)

- with auditory impairment

- pregnant, parturient, breast-feeding

Schizophrenia patients:

- if aged less than 18 years or more than 60 years

- significant secondary effects of antipsychotic medication, measured with the Barnes and AIMS scales

- with a neurodegenerative disease

- with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)

- with auditory impairment

- pregnant, parturient, breast-feeding

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
France University Hospital of Grenoble Grenoble

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Grenoble Speech and Cognition Department, GIPSA-lab

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Labial EMG activity during auditory verbal hallucination up to 3 years No
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