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Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects (SCINTIK)

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ClinicalTrials.gov Identifier: NCT02337023
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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).

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.


Condition or disease Intervention/treatment
Healthy Subjects Kleine-Levin Syndrome Radiation: Brain scintigraphy with injection of Neurolite® (ECD)

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


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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects
Study Start Date : May 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Group/Cohort Intervention/treatment
healthy subjects Radiation: Brain scintigraphy with injection of Neurolite® (ECD)
Brain scintigraphy with injection of Neurolite® (ECD) 1 injection

patients with Kleine-Levin Syndrome Radiation: Brain scintigraphy with injection of Neurolite® (ECD)
Brain scintigraphy with injection of Neurolite® (ECD) 1 injection




Primary Outcome Measures :
  1. Brain perfusion. [ Time Frame: day 0 ]
    Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects
Criteria

Inclusion criteria :

  • 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

Exclusion criteria :

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337023


Locations
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France
Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Isabelle ARNULF, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02337023     History of Changes
Other Study ID Numbers: P101002
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Brain scintigraphy

Additional relevant MeSH terms:
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Syndrome
Kleine-Levin Syndrome
Disease
Pathologic Processes
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Technetium Tc 99m bicisate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action