Clinical Trial: Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

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.


Detailed Summary:

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


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Brain perfusion. [ Time Frame: day 0 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 5, 2014
Date Started: May 2011
Date Completion:
Last Updated: July 20, 2015
Last Verified: July 2015