- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03157869
Influence of Transcranial Direct Stimulation Current on Motor Learning of Young Adults
10. oktober 2018 oppdatert av: Maria Elisa Pimentel Piemonte, University of Sao Paulo General Hospital
Motor learning occurs with structural and functional modifications in neural networks that meet a certain demand.
The improvement of performance in diverse activities is a measure of learning, as well as the generalization and transference of this capacity.
Transcranial direct current stimulation (tDCS) is a modulation technique of brain activity that modifies cortical excitability, causing changes in motor evoked potentials that influence motor learning.
Modifications similar to the long-term potentiation, essential for learning processes, have also been described after applying tDCS.
The primary motor cortex is the area of stimulation where there is more robust evidence in favor of increased motor learning.
PURPOSE: to investigate the effects of anodic tDCS on the learning of sequential finger movements in young and healthy individuals.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Thirty-six young healthy individuals, right-handed, with no deficits that difficult the performance of the procedures will participate in the study.
These individuals will be randomly divided into an experimental group that will perform the motor training of a sequential task of fingers simultaneously to the anodic tDCS on the contralateral motor cortex the trained hand and a control group that will perform the same training simultaneously the stimulation placebo (simulated in the same region of the experimental group).
The training will consist of 8 blocks with 300 repetitions of sequential finger movements performed with only the right upper limb.
The speed and accuracy of sequential movements will be used as a measure of performance.
These measures will be performed prior to training, immediately after, 48 hours, 7 days, and 28 days after trained hand training (TH) for assessment of short and long term learning.
In addition, performance evaluations (1) of the reverse-trained sequence in TH will be performed to evaluate the generalization; (2) of the trained sequence in left hand (non-trained) to evaluate the intermanual transfer; and (3) trained sequence in TH in double-task condition to evaluate automaticity.
Appropriate statistical methods will be used to identify inter- and intra-group differences.
Studietype
Intervensjonell
Registrering (Forventet)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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SP
-
São Paulo, SP, Brasil, 05360-000
- Rekruttering
- Center of Research of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University
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Ta kontakt med:
- Maria Elisa P Piemonte, PhD
- Telefonnummer: 5511982082830
- E-post: elisapp@usp.br
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Hovedetterforsker:
- Andrea P Zomignani, PhD student
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Young subjects aged between 18 and 35 years, right-hand (evaluated by the Edinburgh Inventory), of both genders, attending the third grade in a private university.
Exclusion Criteria:
- Individuals using central nervous system drugs with uncorrected visual and / or auditory disorders who have any neurological, psychiatric, or orthopedic diseases and who have differentiated finger, musician or typist skills will be excluded.
Due to the electrostimulation procedure, individuals who use hair chemistry, individuals who have a metallic implant on the head or a pacemaker, and who have scars in the region to be stimulated will also be excluded.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Transcranial Direct Current Stimulation
|
Anodic tDCS during 20 minutes ON, intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training.
The cathode (negative electrode) will be positioned over the contralateral supraorbital region.
It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).
|
Sham-komparator: Control
|
Simulated anodic tDCS (only 30 seconds ON), intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training.
The cathode (negative electrode) will be positioned over the contralateral supraorbital region.
It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Speed
Tidsramme: Up to 28 days
|
The speed (number of repetitions in a minute) of sequential movements will be used as a measure of performance.
These measures will be performed prior to training, immediately after, 48 hours, 7 days, and 28 days after trained hand training (TH) for assessment of short and long term learning.
In addition, performance evaluations (1) of the reverse-trained sequence in TH will be performed to evaluate the generalization; (2) of the trained sequence in left hand (non-trained) to evaluate the intermanual transfer; and (3) trained sequence in TH in double-task condition to evaluate automaticity.
|
Up to 28 days
|
Accuracy
Tidsramme: Up to 28 days
|
The accuracy (number of errors in a minute) in the same way as described to Outcome 1
|
Up to 28 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Maria Elisa P Piemonte, PhD, University of Sao Paulo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. april 2017
Primær fullføring (Faktiske)
5. april 2018
Studiet fullført (Forventet)
5. november 2018
Datoer for studieregistrering
Først innsendt
1. mai 2017
Først innsendt som oppfylte QC-kriteriene
16. mai 2017
Først lagt ut (Faktiske)
17. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- tDCS1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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