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The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers

20. april 2017 opdateret af: michal roll, Tel-Aviv Sourasky Medical Center

The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in age-matched controls. In this population the DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.

In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.

The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk.

Pre- and post-tDCS assessments will include:

Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015; Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.

Fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.

Cognitive assessment: A detailed computerized cognitive battery that has been used extensively at TASMC in different cohorts [Dwolatzky et al. 2003;Hausdorff et al. 2006;Springer et al. 2006;Yogev et al. 2005;Aarsland et al. 2003] will quantify several cognitive domains including working memory, executive function, verbal function, problem solving, a global cognitive score, and attention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Roslindale, Massachusetts, Forenede Stater, 02121
        • Rekruttering
        • Hebrew Rehabilitation Center / Harvard Medical School
        • Underforsker:
          • Lewis Lipsitz, MD
        • Ledende efterforsker:
          • Brad Manor, PhD
        • Kontakt:
        • Kontakt:
          • Lewis Lipsitz, MD
  • Israel
      • Tel Aviv, Israel, 64239

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

65 år til 85 år (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. age 65-85 years,
  2. ability to walk for 6 minutes unassisted,
  3. adequate vision capabilities, and
  4. stable medications for the past month.

Exclusion Criteria:

  1. diagnosis of stroke, Parkinson's disease, peripheral neuropathy or other neurologic disorder,
  2. lower-extremity deformity, joint replacement, severe arthritis or other diagnosed musculoskeletal disorder that may influence gait,
  3. orthostatic hypotension, recent history of syncope or vertigo,
  4. myocardial infarction or surgery within the past 6 months,
  5. any unstable medical condition,
  6. psychiatric co-morbidity (e.g., major depressive disorder as determined by DSM V criteria),
  7. likely dementia (i.e., Mini Mental State Exam score < 24 or based on DSM V),
  8. sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants,
  9. colorblindness (confounder for cognitive assessment), or
  10. contraindications to tDCS

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: tDCS

The active tDCS condition will consist of 4 visit:

During each visit, subject will receive a single 20-minute session targeting the prefrontal cortices of either real (1.5 mA) or sham tDCS. Total 4 different targets:

  1. Sham
  2. motor M1 area
  3. motor M1 + Dorsolateral Prefrontal cortex
  4. Dorsolateral Prefrontal cortex.

The tDCS condition will be randomized and double blinded
Enhed: tDCS
The active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions.
Andre navne:
  • Transkraniel jævnstrømsstimulering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immediate change in gait speed
Tidsramme: 1st measure will be taken at baseline ans 2nd immediate post intervention
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
1st measure will be taken at baseline ans 2nd immediate post intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
fNIRS related frontal lobe activation - changes in tissue oxygenation
Tidsramme: 1st measure will be taken at baseline ans 2nd immediate post intervention
fNIRS will be used to investigate the role of the frontal lobe in DT walking and how it is affected by tDCS.The fNIR system provides with real-time monitoring of tissue oxygenation in the brain as subjects take different tests.
1st measure will be taken at baseline ans 2nd immediate post intervention
Changes in cognitive performance - Executive Function composite score
Tidsramme: 1st measure will be taken at baseline ans 2nd immediate post intervention
The NeuroTrax software uses tests of cognitive performance that measure similar cognitive functions to traditional paper-based tests.
1st measure will be taken at baseline ans 2nd immediate post intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Tel-Aviv Sourasky Medical Center

Efterforskere

  • Ledende efterforsker: Nir Giladi, Prof., Tel Aviv Sourasky medical Center, Tel Aviv, Israel

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. november 2016

Primær færdiggørelse (Forventet)

1. december 2017

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

31. oktober 2016

Først indsendt, der opfyldte QC-kriterier

1. november 2016

Først opslået (Skøn)

3. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TASMC-16-NG-0699-CTIL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med tDCS

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