Neuropsychiatric DisordersBIPNCT02523742
Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects
A study testing IMRf and language task and a reference task (rest and Tamil) in people with Neuropsychiatric Disorders, run by University Hospital, Caen.
Trial summary
Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropsychiatric Disorders
- What is being tested?
- IMRf and language task and a reference task (rest and Tamil)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to 23 Apr 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients under 65 years
- Schizophrenics, bipolar or schizoaffective (DSM IV)
- Patients who signed informed consent
Who cannot join
- Women with childbearing potential without effective contraception or positive pregnancy test.
- Contra-indications to fMRI
About this study
Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness.
Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.
- Conditions
- Neuropsychiatric Disorders
- Being tested
- IMRf, language task and a reference task (rest and Tamil)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRfDevice
language task and a reference task (rest and Tamil)Other
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychiatric Disorders | Other | Neuropsychiatric Disorders patients Receives: Device: IMRf; Other: language task and a reference task (rest and Tamil) |
| Healthy volunteers | Other | control subjects matched to patients by age, sex, socio-cultural level and laterality Receives: Device: IMRf; Other: language task and a reference task (rest and Tamil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startNov 2005
- Primary completion19 Nov 2013
- Study completion23 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychiatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523742
- Sponsor's protocol ID
- 05-097
- Acronym
- BIP
- Status last verified
- Aug 2015
- First submitted
- 13 Aug 2015
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects
- ClinicalTrials.gov ID
- NCT02523742
- Acronym / sponsor ID
- BIP / 05-097
- Conditions
- Neuropsychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- 19 Nov 2013 (actual)
- Study completion
- 23 Apr 2015 (actual)
- First posted
- 14 Aug 2015 (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.
Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness.
Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropsychiatric Disorders | Other | Device: IMRf, Other: language task and a reference task (rest and Tamil)Neuropsychiatric Disorders patients |
| Healthy volunteers | Other | Device: IMRf, Other: language task and a reference task (rest and Tamil)control subjects matched to patients by age, sex, socio-cultural level and laterality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients under 65 years
- Schizophrenics, bipolar or schizoaffective (DSM IV)
- Patients who signed informed consent
Key exclusion criteria (2 listed)
- Women with childbearing potential without effective contraception or positive pregnancy test.
- Contra-indications to fMRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRf | Device | Healthy volunteers, Neuropsychiatric Disorders |
| language task and a reference task (rest and Tamil) | Other | Healthy volunteers, Neuropsychiatric Disorders |
Primary outcome
variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest
Time frame: baseline
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 1 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IMRf and language task and a reference task (rest and Tamil) in people with Neuropsychiatric Disorders, run by University Hospital, Caen.
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 3 inclusion and 2 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest (time frame: baseline). 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 1 Sep 2020.