Skip to main content
OpenTrials
Completed

NCT Number: NCT02337023

Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain scintigraphy with injection of Neurolite® (ECD)

Radiation

Brain scintigraphy with injection of Neurolite® (ECD) 1 injection

Primary outcomes

  1. Brain perfusion.

    Time frame: day 0

    Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: SCINTIK

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.