NCT02337023

Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
RADIATION	Brain scintigraphy with injection of Neurolite® (ECD)	Brain scintigraphy with injection of Neurolite® (ECD) 1 injection

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-01-13
• Last updated: 2015-07-21

Locations

1 site across 1 country: France