Healthy VolunteerINNERSPEECHNCT02830100
Neural Correlates of Intern Speech
A study testing Healthy volunteers and MRI in people with Healthy Volunteer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The goal is to define what is the nature of intern speech, how it manifests itself, who deal with agency in intern speech and finally what is the role of intern speech in attention tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Healthy volunteers and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2015to 12 Dec 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
- Between 18 and 65 years
- Right-handed
- French as mother tongue
- Visual acuity that allow to read stimulis (contact lens authorized)
- Healthy subject
Who cannot join
- Respiratory or cardio-vascular pathology
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to define what is the nature of intern speech, how it manifests itself, who deal with agency in intern speech and finally what is the role of intern speech in attention tasks.
Read the detailed description
Intern speech has a main goal in memory, thinking and self-awareness. So this study might bring information in order to better understand any potential adverse effect on depression or anxiety disorders for example.
- Conditions
- Healthy Volunteer
- Being tested
- Healthy volunteers, MRI
- Keywords
- Intern speech, Speech and visual imaging, Mind and oral drift, Cognitive performance, Magnetic Resonance Imaging
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy volunteersOther
Magnetic Resonance Imaging during intern speech, listening, talking, thinking.
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Other: Healthy volunteers; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study intern speech
Magnetic Resonance Imaging while talking, thinking, listening
Measured: About an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start23 Jul 2015
- Primary completion12 Dec 2015
- Study completion12 Dec 2015
Why it stopped: no more subjects for recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Krainik, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830100
- Sponsor's protocol ID
- 38RC14.304
- Acronym
- INNERSPEECH
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baciu MV, Rubin C, Decorps MA, Segebarth CM. fMRI assessment of hemispheric language dominance using a simple inner speech paradigm. NMR Biomed. 1999 Aug;12(5):293-8. doi: 10.1002/(sici)1099-1492(199908)12:53.0.co;2-6.
PubMed 10484818Basho S, Palmer ED, Rubio MA, Wulfeck B, Muller RA. Effects of generation mode in fMRI adaptations of semantic fluency: paced production and overt speech. Neuropsychologia. 2007 Apr 9;45(8):1697-706. doi: 10.1016/j.neuropsychologia.2007.01.007. Epub 2007 Jan 16.
PubMed 17292926Bookheimer SY, Zeffiro TA, Blaxton T, Gaillard W, Theodore W. Regional cerebral blood flow during object naming and word reading. Human Brain Mapping. 1995;3:93-106.
Clark A, Karmiloff-Smith A. The cognizer's innards: a psychological and philosophical perspective on the development of thought. Mind & Language. 1993;8:487-519.
Conrad B, Schonle P. Speech and respiration. Arch Psychiatr Nervenkr (1970). 1979 Apr 12;226(4):251-68. doi: 10.1007/BF00342238.
PubMed 454139Davis RN, Nolen-Hoeksema S. Cognitive inflexibility among ruminators and nonruminators. Cognitive Therapy and Research. 2000;24:699-711.
Frings M, Dimitrova A, Schorn CF, Elles HG, Hein-Kropp C, Gizewski ER, Diener HC, Timmann D. Cerebellar involvement in verb generation: an fMRI study. Neurosci Lett. 2006 Nov 27;409(1):19-23. doi: 10.1016/j.neulet.2006.08.058. Epub 2006 Oct 12.
PubMed 17046160Huang J, Carr TH, Cao Y. Comparing cortical activations for silent and overt speech using event-related fMRI. Hum Brain Mapp. 2002 Jan;15(1):39-53. doi: 10.1002/hbm.1060.
PubMed 11747099Lupyan G. Extracommunicative functions of language: verbal interference causes selective categorization impairments. Psychon Bull Rev. 2009 Aug;16(4):711-8. doi: 10.3758/PBR.16.4.711.
PubMed 19648457McGuire PK, Silbersweig DA, Murray RM, David AS, Frackowiak RS, Frith CD. Functional anatomy of inner speech and auditory verbal imagery. Psychol Med. 1996 Jan;26(1):29-38. doi: 10.1017/s0033291700033699.
PubMed 8643761Morin A. Inner Speech Encyclopedia of Human Behavior. 2012;Elsevier:436-43.
Netsell R, Ashley E, Bakker K. The Inner Speech of Persons who Stutter. Proceedings of the International Motor Speech Conference. Savannah, Georgia2010
Olivers CN, Nieuwenhuis S. The beneficial effects of additional task load, positive affect, and instruction on the attentional blink. J Exp Psychol Hum Percept Perform. 2006 Apr;32(2):364-79. doi: 10.1037/0096-1523.32.2.364.
PubMed 16634676Owen WJ, Borowsky R, Sarty GE. FMRI of two measures of phonological processing in visual word recognition: ecological validity matters. Brain Lang. 2004 Jul-Sep;90(1-3):40-6. doi: 10.1016/S0093-934X(03)00418-8.
PubMed 15172523Palmer ED, Rosen HJ, Ojemann JG, Buckner RL, Kelley WM, Petersen SE. An event-related fMRI study of overt and covert word stem completion. Neuroimage. 2001 Jul;14(1 Pt 1):182-93. doi: 10.1006/nimg.2001.0779.
PubMed 11525327
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Intern Speech
- ClinicalTrials.gov ID
- NCT02830100
- Acronym / sponsor ID
- INNERSPEECH / 38RC14.304
- Conditions
- Healthy Volunteer
- Keywords
- Intern speech, Speech and visual imaging, Mind and oral drift, Cognitive performance, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more subjects for recrutment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 12 Dec 2015 (actual)
- Study completion
- 12 Dec 2015 (actual)
- First posted
- 12 Jul 2016 (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.
The goal is to define what is the nature of intern speech, how it manifests itself, who deal with agency in intern speech and finally what is the role of intern speech in attention tasks.
Detailed description
Intern speech has a main goal in memory, thinking and self-awareness. So this study might bring information in order to better understand any potential adverse effect on depression or anxiety disorders for example.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Healthy volunteers, Device: MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 and 65 years
- Right-handed
- French as mother tongue
- Visual acuity that allow to read stimulis (contact lens authorized)
- Healthy subject
Key exclusion criteria (2 listed)
- Respiratory or cardio-vascular pathology
- Claustrophobia
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 |
|---|---|---|
| Healthy volunteersMagnetic Resonance Imaging during intern speech, listening, talking, thinking. | Other | Healthy volunteers |
| MRI | Device | Healthy volunteers |
Primary outcome
Study intern speech
Time frame: About an hour
Magnetic Resonance Imaging while talking, thinking, listening
Results and safety
The study was stopped early (reason given: no more subjects for recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 10484818Baciu MV, Rubin C, Decorps MA, Segebarth CM. fMRI assessment of hemispheric language dominance using a simple inner speech paradigm. NMR Biomed. 1999 Aug;12(5):293-8. doi: 10.1002/(sici)1099-1492(199908)12:53.0.co;2-6.
- Background: PubMed 17292926Basho S, Palmer ED, Rubio MA, Wulfeck B, Muller RA. Effects of generation mode in fMRI adaptations of semantic fluency: paced production and overt speech. Neuropsychologia. 2007 Apr 9;45(8):1697-706. doi: 10.1016/j.neuropsychologia.2007.01.007. Epub 2007 Jan 16.
- BackgroundBookheimer SY, Zeffiro TA, Blaxton T, Gaillard W, Theodore W. Regional cerebral blood flow during object naming and word reading. Human Brain Mapping. 1995;3:93-106.
- BackgroundClark A, Karmiloff-Smith A. The cognizer's innards: a psychological and philosophical perspective on the development of thought. Mind & Language. 1993;8:487-519.
- Background: PubMed 454139Conrad B, Schonle P. Speech and respiration. Arch Psychiatr Nervenkr (1970). 1979 Apr 12;226(4):251-68. doi: 10.1007/BF00342238.
- BackgroundDavis RN, Nolen-Hoeksema S. Cognitive inflexibility among ruminators and nonruminators. Cognitive Therapy and Research. 2000;24:699-711.
- Background: PubMed 17046160Frings M, Dimitrova A, Schorn CF, Elles HG, Hein-Kropp C, Gizewski ER, Diener HC, Timmann D. Cerebellar involvement in verb generation: an fMRI study. Neurosci Lett. 2006 Nov 27;409(1):19-23. doi: 10.1016/j.neulet.2006.08.058. Epub 2006 Oct 12.
- Background: PubMed 11747099Huang J, Carr TH, Cao Y. Comparing cortical activations for silent and overt speech using event-related fMRI. Hum Brain Mapp. 2002 Jan;15(1):39-53. doi: 10.1002/hbm.1060.
- Background: PubMed 19648457Lupyan G. Extracommunicative functions of language: verbal interference causes selective categorization impairments. Psychon Bull Rev. 2009 Aug;16(4):711-8. doi: 10.3758/PBR.16.4.711.
- Background: PubMed 8643761McGuire PK, Silbersweig DA, Murray RM, David AS, Frackowiak RS, Frith CD. Functional anatomy of inner speech and auditory verbal imagery. Psychol Med. 1996 Jan;26(1):29-38. doi: 10.1017/s0033291700033699.
- BackgroundMorin A. Inner Speech Encyclopedia of Human Behavior. 2012;Elsevier:436-43.
- BackgroundNetsell R, Ashley E, Bakker K. The Inner Speech of Persons who Stutter. Proceedings of the International Motor Speech Conference. Savannah, Georgia2010
Related trials for Healthy Volunteer
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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.
Alexandre Krainik, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy volunteers and MRI in people with Healthy Volunteer, 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 5 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: stopped early, as of the sponsor's last update on 15 Oct 2018. 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 was stopped early (reason given: no more subjects for recrutment). Results are not available in the source record.
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?
Study intern speech (time frame: About an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830100, which also lists 21 linked publications.
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 15 Oct 2018.