- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04787406
Motor Learning and tDCS in Parkinson's Disease
The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Hung Hom
-
Hong Kong, Hung Hom, Hong Kong
- The Hong Kong Polytechnic University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Right-handed (Edinburgh Handedness Inventory; ≥50)
- Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
- Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
Exclusion Criteria:
- History of stroke
- Comorbidity
- Cephalic implants
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Anodal tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
Andre navne:
|
Aktiv komparator: Cathodal tDCS
Cathodal electrode (35 cm2 sponge electrode) placed over C3.
Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
Andre navne:
|
Sham-komparator: Sham tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
Stimulation was phased in for 30 seconds up to 2 mA and then switched off.
Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline sequential finger tapping performance
Tidsramme: Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.
|
Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
Change from baseline oxygenated haemoglobin response
Tidsramme: Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
|
Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
Change from baseline shape-counting error
Tidsramme: Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
The percentage of shape counting error during dual task assessments.
Sequential finger tapping + visual shape counting task.
|
Two assessments: Baseline / pre-intervention, and immediately post-intervention
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Magaret Mak, Dr, The Hong Kong Polytechnic University
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
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSEARS20181226002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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