SchizophreniaHAVNCT01886417
Auditory Verbal Hallucinations in Schizophrenia
An observational study of Schizophrenia, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: in- and out-patients
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyography Study of Lip Muscles During Auditory Verbal Hallucinations Without Subvocalization in Patients With Schizophrenia
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.
- Conditions
- Schizophrenia
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Labial EMG activity during auditory verbal hallucination
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startOct 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- GIPSA-LAB
- Responsible party
- Sponsor
- Investigators
- Thierry BOUGEROL, MD, PHD, HDR, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886417
- Sponsor's protocol ID
- 0906
- Other IDs
- 2009-A00248-49
- Acronym
- HAV
- Status last verified
- Mar 2015
- First submitted
- 21 Jun 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography Study of Lip Muscles During Auditory Verbal Hallucinations Without Subvocalization in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01886417
- Acronym / sponsor ID
- HAV / 0906
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- GIPSA-LAB
- Study start
- Oct 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- in- and out-patients
Key inclusion criteria (14 listed)
- 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
- must be more than 18 years and less than 60 years old
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Labial EMG activity during auditory verbal hallucination
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry BOUGEROL, MD, PHD, HDR principal investigator
University Hospital of Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labial EMG activity during auditory verbal hallucination (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.