NCT01886417

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5.4 years

First QC Date

June 21, 2013

Last Update Submit

March 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Labial EMG activity during auditory verbal hallucination

    up to 3 years

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

in- and out-patients

You may qualify if:

  • Healthy controls:
  • must be more than 18 years and less than 60 years old
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Thierry BOUGEROL, MD, PHD, HDR

    University Hospital of Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

October 1, 2009

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations