3D gait analysis and L-DOPA in Dravet syndrome.

JRCT ID: jRCTs041190116

Registered date:17/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dravet syndrome(severe myoclonic epilepsy in infant)
• Date of first enrollment: 17/02/2020
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Arm A:0) 3D gait analysis and RS-fMRI before medication 1) levodopa/carbidopa(5mg/kg/day or 300mg/day(more than 60kg)) given orally during 4-6weeks 2) second 3D gait analysis and RS-fMRI 3) reduce and stop medication durring 4weeks, no medication during 4-6weeks 4)third 3D gait analysis
Arm B:0) 3D gait analysis and RS-fMRI before medication 1) 4-6weeks with no medication 2) second 3D gait analysis 3) levodopa/carbidopa given orally during 4-6weeks 4)third 3D gait analysis and second RS-fMRI

Outcome(s)

• Primary Outcome: Gait Deviation Index at before and after L-DOPA administration

Secondary Outcome

Gait Profile Score, gait ability and QOL assessed by questionnaire at before and after L-DOPA administration
UPDRS score, FMDRS score
functional connectivities of basal ganglia network before and after L-DOPA adminiatration

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.clinically diagnosed with Dravet syndrome
2.6 years or older, exhibiting gait deviations
3.adequately participation to 3D gait analysis with independent walk
4.written informed consent

Exclude criteria

1.unnable to participate to 3D gait analysis adequately
2.past prescription of L-DOPA
3.contraindication for L-DOPA
4.severe general complications
5.cannnot obtain informed consent

Related Information

• Primary Sponsor: Natsume Jun