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

July 20, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain perfusion.
Time Frame: day 0
Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Isabelle Arnulf, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

January 8, 2015

First Posted (ESTIMATE)

January 13, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P101002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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