- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05219006
Ketogene diæteffekter på hyppigheden af ikke-epileptiske anfald
Ketogen diæts virkninger på hyppigheden af ikke-epileptiske anfald hos patienter med dissociativ neurologisk symptomlidelse: en pilotundersøgelse
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse består af et åbent randomiseret kontrolleret klinisk forsøg bestående af 20 patienter med diagnosen funktionel neurologisk symptomlidelse med ikke-epileptiske anfald fordelt i 2 arme af hver 10 patienter.
Patienterne vil blive tilfældigt fordelt i en af grupperne. Begge grupper vil modtage behandling som normalt (SSRI og/eller psykoterapi). Den ene gruppe vil blive tildelt en ketogen diæt, mens den anden vil blive tildelt en sund kost, begge overvåget af et team af ernæringseksperter. Patienterne vil blive evalueret hver anden uge, indtil de når 6 uger.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ciudad De Mexico
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Mexico, Ciudad De Mexico, Mexico, 14269
- Instituto Nacional de Neurologia Y Neurocirugia Mvs
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Patienter, der har en journal på instituttet, og som har diagnosen dissociativ neurologisk symptomlidelse med ikke-epileptiske anfald med en sikkerhed på mindst klinisk etableret, som har en månedlig anfaldshyppighed større end 3.
- Patienter med de ovenfor beskrevne karakteristika med komorbid epilepsi, men som ikke har haft epileptiske anfald inden for den sidste måned.
- Patienter med ovennævnte karakteristika, og som skriftligt giver deres informerede samtykke til at deltage i undersøgelsen.
- Patienter, som, når diæten er blevet forklaret dem, anser det for muligt at implementere den i det mindste i opfølgningstiden.
Ekskluderingskriterier:
- Patienter med metabolisk eller hæmodynamisk ustabilitet, leversvigt, manglende evne til at tolerere den orale vej, akut pancreatitis eller graviditet på grund af den mulige teratogene effekt, som endnu ikke er blevet belyst.
- Patienter med metaboliske lidelser såsom primær carnitin-mangel, palmitoyltransferase carnitin I eller II-mangel, carnitin-translocase-mangel, beta-oxidationsdefekter, pyruvatcarboxylase-mangel, porfyri og andre fedtsyretransport- og oxidationsforstyrrelser.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ketogen slankekure + konventionel behandling
Ernæringsteamet vil hjælpe patienter med at implementere en ketogen diæt af Atkins-typen.
Diæten bør fortsættes i mindst 6 uger.
De vil kunne fortsætte med den farmakologisk baserede behandling, men uden at der er foretaget ændringer inden for de sidste 6 uger eller i den tid, de er i undersøgelsen.
For at sikre overholdelse af diæten vil urinketoner blive bestemt to gange om ugen.
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Atkins modificeret diæt: 1,2-1,5 g/kg/dag protein i forholdet 1:1 (fedt: kulhydrat + protein)
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Aktiv komparator: Sund kost + konventionel behandling
Ud over deres grundlæggende (farmakologiske) behandling vil ernæringsteamet hjælpe dem med at implementere en kaloriefattig, ikke-ketogen diæt.
Tilstedeværelsen af ketoner vil også blive bestemt i urinen for at undgå bias
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Normokalorisk diæt etableret af en ernæringsekspert.
1,2-1,5 g/kg/dag protein med et maksimalt bidrag på 50 % kulhydrater af det samlede kalorieindtag, hvilket eliminerer industrialiseret mad.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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ikke-epileptiske anfaldsfrekvens
Tidsramme: 2 uger
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antal ikke-epileptiske anfald patienten indberetter på en skriftlig krisejournal med hjælp fra en pårørende om nødvendigt
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2 uger
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Edgar Crail Meléndez, MS, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Publikationer og nyttige links
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Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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