Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

NCT02337023 | Completed

• 1 other identifier: P101002
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Kleine-Levin Syndrome

Keywords

Brain scintigraphy

Outcome Measures

Primary Outcomes (1)

• Brain perfusion.

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

  day 0

Study Arms (2)

healthy subjects

Radiation: Brain scintigraphy with injection of Neurolite® (ECD)

patients with Kleine-Levin Syndrome

Radiation: Brain scintigraphy with injection of Neurolite® (ECD)

Interventions

Brain scintigraphy with injection of Neurolite® (ECD) RADIATION

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

healthy subjects; patients with Kleine-Levin Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Kleine-Levin Syndrome

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Isabelle ARNULF, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: January 13, 2015
• Study Start: May 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

FR (1)