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Behandling af kognitive og sensorimotoriske defekter ved Parkinsons sygdom med højopløsningstranskraniell jævnstrømsstimulering

7. maj 2026 opdateret af: John Hart, Jr., The University of Texas at Dallas

Behandling af kognitive og sensorimotoriske mangler ved Parkinsons sygdom med højopløsningstranskranial jævnstrømsstimulering

Formålet med denne forskningsundersøgelse er at undersøge effekterne af transkraniel jævnstrømsstimulering (tDCS) på verbal gendannelse og kognition samt sensorimotorisk kontrol og at afgøre, om tDCS kan bruges som en metode til at forbedre gendannelses-, sensoriske og motoriske evner hos personer med Parkinsons sygdom (PD).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Formål: Baseret på modeller for semantisk hukommelseshentning udviklet af vores gruppe, hvori det dorsomediale frontallaps pre-supplementary motor area (preSMA) spiller en vigtig rolle, foreslår vi at behandle kognitive defekter i PD med HD tDCS anvendt på preSMA for at forbedre funktionen i neurale kredsløb, der understøtter verbal hentning. Derudover, da preSMA er involveret i motorisk planlægning og sekventering, undersøger vi også, om HD tDCS anvendt på preSMA vil have en effekt på tale og gang.

Specifikke mål:

  1. Undersøge de terapeutiske effekter på verbal hentningsfunktion ved at modulere preSMA ved hjælp af HD tDCS.
  2. Undersøge de terapeutiske effekter på taleproduktion og -behandling ved at modulere preSMA ved hjælp af HD tDCS
  3. Undersøge de terapeutiske effekter på gang og balance ved at modulere preSMA ved hjælp af HD tDCS

Hypoteser:

  1. : Aktiv HD tDCS (1 mA anodal HD tDCS til preSMA sammenlignet med sham) vil forbedre verbal flyd (dvs. fonemisk og kategoriflyd på Controlled Word Association Test) som primære udfaldsmål.
  2. : Aktiv HD tDCS (1 mA anodal HD tDCS til preSMA sammenlignet med sham) vil forbedre talesekventering.
  3. : Aktiv HD tDCS (1 mA anodal HD tDCS til preSMA sammenlignet med sham) vil forbedre generel motorsekventering

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnosticeret med PD med et verbalt flydeforstyrrelse
  • 50 - 90 år gammel
  • I stand til at forstå og underskrive en informeret samtykke (i stand til at besvare samtykkeforståelsesspørgsmål)
  • Flydende i at tale og læse engelsk

Eksklusionskriterier:

  • En potentielt forvirrende psykologisk eller neurologisk lidelse, herunder epilepsi eller andre anfaldslidelser; alvorlig traumatisk hjerneskade (baseret på Ohio State TBI Identification Method); hjernesvulst; slagtilfælde; nuværende stofmisbrug/-forbrug; eller Huntingtons sygdom. Deltagere, der bliver set i PIs klinikker, vil blive vurderet for disse problemer som en del af den standard kliniske vurdering.
  • Derudover inkluderer eksklusionskriterier kranielle implantater eller kraniedefekter, der påvirker tDCS-administration; og brug af medicin, der interagerer med eller potentielt interagerer med tDCS-effekter, herunder antikonvulsiva, carbamazepin, sulpirid, pergolid, lorazepam, rivastigmin, dextrometorfan, D-cycloserin, flunarizin, ropinirol eller citalopram
  • Patienter med en diagnose af kun dysartri eller som har en dyb hjerne-stimulation (DBS)-enhed vil blive ekskluderet.
  • Derudover vil ikke-engelsktalende blive ekskluderet, fordi ikke alle screeningsformularer, spørgeskemaer og tests er tilgængelige på andre sprog end engelsk.
  • Personer med kognitiv svækkelse, indikeret ved en score på 22 eller mindre på Montreal Cognitive Assessment, vil blive overvejet til eksklusion på grund af bekymringen om en reduceret evne til at give samtykke. Deltagere med en score på 22 eller mindre vil kun kunne deltage, hvis de har en medfølgende studiemakker/omsorgsgiver med sig, og vi kan opnå det skriftlige samtykke fra både deltageren og deltagerens medfølgende studiemakker/omsorgsgiver, som vil være deltagerens ægtefælle, voksne barn, forælder eller voksen søskende. Hvis de ikke har en medfølgende studiemakker/omsorgsgiver, vil de ikke blive tilladt at deltage på det tidspunkt. De vil dog blive tilladt at komme tilbage på et senere tidspunkt med en medfølgende studiemakker/omsorgsgiver og fortsætte med samtykkeprocedurerne og studiet som ovenfor.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham transkraniel jævnstrømsstimulering
Sham transkraniel jævnstrømsstimulering vil blive leveret via en Neuroelectrics Starstim tES. Sham-opsætningen vil bestå af anodale elektrode Fz (International 10/10 System for elektroencefalografi elektrodeplacering) og elektroder F7, FP1, FP2 og F8 som returnerer. Alle elektroder er 1 cm diameter Ag/AgCl elektroder og kommer i kontakt med hovedbunden via bindegel. Stimulering vil lineært rampe op fra 0 milliampere til 1 milliampere i løbet af 60 sekunder, rampe ned til 0 milliampere over 60 sekunder og derefter stå ude i 20 minutter.
Enhed: Sham transkraniel jævnstrømsstimulering
Sham transkraniel jævnstrømsstimulering vil blive leveret via en Neuroelectrics Starstim tES. Sham-opsætningen vil bestå af anodale elektrode Fz (International 10/10 System for elektroencefalografi elektrodeplacering) og elektroder F7, FP1, FP2 og F8 som returnerer. Alle elektroder er 1 cm diameter Ag/AgCl elektroder og kommer i kontakt med hovedbunden via bindegel. Stimulering vil lineært rampe op fra 0 milliampere til 1 milliampere i løbet af 60 sekunder, rampe ned til 0 milliampere over 60 sekunder og derefter stå ude i 20 minutter.
Andre navne:
  • sham tDCS
  • Sham transkraniel elektrisk stimulering
  • sham tES
Eksperimentel: Transkraniel jævnstrømsstimulering
Transkraniel jævnstrømsstimulering leveres via en Neuroelectrics Starstim tES. Stimuleringen består af 1 milliamp stimulering, med anodal stimulering leveret ved elektrode Fz (International 10/10 System til elektroencefalografi elektrodeplacering) og elektroderne F7, FP1, FP2 og F8 som returelektroder. Alle elektroder er 1 cm i diameter Ag/AgCl-elektroder og skaber kontakt med hovedbunden via ledningsgel. Stimuleringen vil lineært stige fra 0 milliamp til 1 milliamp over 60 sekunder, forblive ved 1 milliamp stimulering i 20 minutter og til sidst falde til 0 milliamp over 60 sekunder. Andre navne: tDCS 1 milliamp tDCS Højopløsning tDCS Højopløsning transkraniel jævnstrømsstimulator, Neuroelectrics Starstim tES, SN E20200930-10
Enhed: transcranial jævnstrømsstimulering
Transcranial direkte strømstimulering vil blive leveret via en Neuroelectrics Starstim tES. Stimulationen vil bestå af 1 milliamp stimulation, med anodal stimulation leveret ved elektrode Fz (International 10/10 System til elektroencefalografi elektrodeplacering) og elektroderne F7, FP1, FP2 og F8 som returelektroder. Alle elektroder er 1 cm diameter Ag/AgCl elektroder og etablerer kontakt med hovedbunden via ledende gel. Stimulationen vil lineært øges fra 0 milliamp til 1 milliamp over 60 sekunder, forblive ved 1 milliamp stimulation i 20 minutter, og til sidst mindskes til 0 milliamp over 60 sekunder.
Andre navne:
  • tDCS
  • tES
  • transkraniel elektrisk stimulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
valuation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on Phonemic Fluency
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Phonemic Fluency
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: syllables per second on a passage reading task (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during a reading passage (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 1-week post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-month Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 2-month post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: coefficient of variation of syllable duration on a passage reading task (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during a reading passage (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time on a passage reading task (minimum=0%; maximum=100%).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during overt reading
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during a reading passage (minimum=0%; maximum=100%).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during self-generated speech
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task
Tidsramme: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change in freezing of gate from baseline to 1-week post-treatment. Metric: Timed up and go time (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-month Post-treatment on Freezing of Gate during the timed up and go task
Tidsramme: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Evaluation of treatment group differences in change in freezing of gate from baseline to 2-month post-treatment. Metric: Timed up and go time (minimum=0; no maximum).
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas at Dallas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

9. april 2026

Først indsendt, der opfyldte QC-kriterier

9. april 2026

Først opslået (Faktiske)

16. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-26-35

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med PARKINSON SYGGE (lidelse)

Kliniske forsøg med Sham transkraniel jævnstrømsstimulering

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