Healthy SubjectsSCINTIKNCT02337023
Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects
An observational study of Healthy Subjects and Kleine-Levin Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects. These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Kleine-Levin Syndrome
- What is being tested?
- Brain scintigraphy with injection of Neurolite® (ECD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- Subjects males and females with more than 18 y.o, age and sex-matched with patients with Kleine-Levin Syndrome
- with the same educational level and dominant hand than patients with Kleine-Levin Syndrome
- without any brain disease or sleep disease (Epworth score < 11/24) known.
- with social security
- french language
- for women : nonpregnant taking effective contraception
Who cannot join
- Minor subjects
- adults under protection
- subjects with neurologic, psychiatric, somatic or sleep diseases and/or receiving a psychotropic medication interfering with the results.
- subjects with history of seizures or loss of consciousness
- subjects with excessive alcohol consumption (more than 3 doses /day)
- subjects without any social security
- subjects non fluent in french
- for women : no effective contraception or lactation period
Trial locations and contacts
1 site in 1 country.
About this study
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects.
These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).
The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities.
Read the detailed description
3 steps in the protocol :
- Brain ECD-SPECT (marking brain perfusion in relation to brain active/hypoactive area) superimposed on a template T1-weighted brain MRI.
- Extensive cognitive tests of executive functions, verbal memory and fluency , visuospatial ability and memory, reasoning abilities: spontaneous memory complaint, Stroop Color Word Test, Trail Making Test A and B, Direct and Reverse Digit Span Test, Letter and Semantic Fluency Test, Free and Cued Selective Reminding Test, Rey-Osterrieth Complex Figure, Mini-Mental test, Progressive matrice of Raven (PM-38)
- KLS-inventory and face to face interview of patients and parents by neurologist for patients. Modified KLS-inventory for healthy subjects.
Main outcome : Number of patients with persisting hypoperfused brain area (compared to controls), location of these area, number of patients with at least -1SD in one cognitive domain Correlation between KLS severity (disease course, number of episode, mean duration of episodes, time incapacitated, number of symptoms) and brain perfusion and cognitive abnormalities
- Conditions
- Healthy Subjects, Kleine-Levin Syndrome
- Being tested
- Brain scintigraphy with injection of Neurolite® (ECD)
- Keywords
- Brain scintigraphy
- Medical subject headings
- Kleine-Levin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain scintigraphy with injection of Neurolite® (ECD)Radiation
Brain scintigraphy with injection of Neurolite® (ECD) 1 injection
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Not described Receives: Radiation: Brain scintigraphy with injection of Neurolite® (ECD) | |
| patients with Kleine-Levin Syndrome | Not described Receives: Radiation: Brain scintigraphy with injection of Neurolite® (ECD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain perfusion.
Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle ARNULF, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337023
- Sponsor's protocol ID
- P101002
- Acronym
- SCINTIK
- Status last verified
- Jul 2015
- First submitted
- 5 Dec 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects
- ClinicalTrials.gov ID
- NCT02337023
- Acronym / sponsor ID
- SCINTIK / P101002
- Conditions
- Healthy Subjects, Kleine-Levin Syndrome
- Keywords
- Brain scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jan 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.
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects.
These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).
The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities.
Detailed description
3 steps in the protocol :
- Brain ECD-SPECT (marking brain perfusion in relation to brain active/hypoactive area) superimposed on a template T1-weighted brain MRI.
- Extensive cognitive tests of executive functions, verbal memory and fluency , visuospatial ability and memory, reasoning abilities: spontaneous memory complaint, Stroop Color Word Test, Trail Making Test A and B, Direct and Reverse Digit Span Test, Letter and Semantic Fluency Test, Free and Cued Selective Reminding Test, Rey-Osterrieth Complex Figure, Mini-Mental test, Progressive matrice of Raven (PM-38)
- KLS-inventory and face to face interview of patients and parents by neurologist for patients. Modified KLS-inventory for healthy subjects.
Main outcome : Number of patients with persisting hypoperfused brain area (compared to controls), location of these area, number of patients with at least -1SD in one cognitive domain Correlation between KLS severity (disease course, number of episode, mean duration of episodes, time incapacitated, number of symptoms) and brain perfusion and cognitive abnormalities
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Radiation: Brain scintigraphy with injection of Neurolite® (ECD) |
| patients with Kleine-Levin Syndrome | – | Radiation: Brain scintigraphy with injection of Neurolite® (ECD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (6 listed)
- Subjects males and females with more than 18 y.o, age and sex-matched with patients with Kleine-Levin Syndrome
- with the same educational level and dominant hand than patients with Kleine-Levin Syndrome
- without any brain disease or sleep disease (Epworth score < 11/24) known.
- with social security
- french language
Key exclusion criteria (8 listed)
- Minor subjects
- adults under protection
- subjects with neurologic, psychiatric, somatic or sleep diseases and/or receiving a psychotropic medication interfering with the results.
- subjects with history of seizures or loss of consciousness
- subjects with excessive alcohol consumption (more than 3 doses /day)
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 |
|---|---|---|
| Brain scintigraphy with injection of Neurolite® (ECD)Brain scintigraphy with injection of Neurolite® (ECD) 1 injection | Radiation | healthy subjects, patients with Kleine-Levin Syndrome |
Primary outcome
Brain perfusion.
Time frame: day 0
Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach
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 21 Jul 2015.
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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.
Isabelle ARNULF, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Healthy Subjects and Kleine-Levin Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 8 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 21 Jul 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?
Brain perfusion. (time frame: day 0). 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 21 Jul 2015.