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Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease

28. oktober 2019 opdateret af: Gad Alon, University of Maryland, Baltimore

Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease

The use of low level electrical stimulation when applied over the head, also called transcranial direct current stimulation (tDCS), is being tested by several groups of researchers to see if tDCS can improve movements of persons with damage to the brain. The safety and potential benefits of tDCS to children or adults patients who are paralyzed because of brain damage are reported in the medical literature. In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending very small amount of electrical current that the patient may feel as "little tingling". Application of tDCS takes 20 min. In this study we wish to test if tDCS application can improve stepping and walking ability of subjects with PD and if the improvement is the same as when walking on treadmill. We plan to test the subject's ability to step when pulled by a laboratory testing system and also test his/her walking ability. There will be 3 sessions 7 days apart. In the first session the subject will be tested then treated for 20 min with tDCS and then tested again. In the second session the subject will be tested then walk on a treadmill for 20 min then tested again. In the third session the subject will be tested then walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the end of the session. Each session will take between 2 and 3 hours.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Recent advances in non-invasive electrical stimulation technology including transcranial direct current stimulation (tDCS) have provided novel and low risk options to rehabilitate the impaired ability of the central nervous system (CNS) to process sensorimotor information. Furthermore, tDCS appears to enhance CNS connectivity and there is preliminary evidence indicating that patients with Parkinson's Disease (PD) may experience improvement in working memory, the Unified Parkinson's Disease Rating Scale, simple reaction time and the Purdue Pegboard test. tDCS is inexpensive, portable and available for repeated home use. It may provide long-lasting enhancement of cortical activity in part because tDCS is easy to administer frequently and to combine it with other rehabilitation approaches including posture and gait training. However to date, no study has examined quantitatively the effects of tDCS on posture control and walking ability in patients with PD. As a first step we plan to identify the immediate effects of tDCS, as well as the added value of tDCS to treadmill exercise training, to improve posture and gait of individuals with PD.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • PTRS Research Lab

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

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of adult onset of PD
  • A history of freezing of gait (FOG) as evidence by clinical assessment
  • A stable regimen of anti-parkinsonian medications
  • Ability to walk at least 10m without assistance
  • Ability to walk on a treadmill for 20 minutes
  • Personal weight of less than 500 Lb (because the suspension harness over the treadmill is limited to 500 Lb
  • Stage 3 of the Hoehn and Yahr disability scale
  • A score of >24 on the Mini Mental State Examination

Exclusion Criteria:

  • Evidence of any clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other neurologic or musculoskeletal disease criterial that would preclude participation in training
  • Any medical condition that might require other medical or surgical treatment during the study period
  • A history of brain surgery or placement of a deep brain stimulator
  • Dyskinesias > grade 2 on the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Any uncorrected vision or hearing problems that may limit daily activities or communication

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Group
10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)
Enhed: Cranial Electric Stimulation (CES)
We will follow the procedure described by several investigators as safe and effective. The participant will sit on a standard chair. Two commercially available surface electrodes will be embedded in an elastic head cup. Each electrode will be covered with a water soaked absorbent fabric. One positive (+) electrode will be placed over the primary motor cortex (M1) and pre-motor areas. One negative (-) electrode will be placed over the skin overlying the contra lateral supra-orbital region. The electrodes will be connected via 2 leads to a battery powered direct current stimulator. The stimulator will be programmed to deliver 0.975mA (peak 4mA) over 20 minutes.
Enhed: Treadmill
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
Enhed: CES and Treadmill
Participants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stride Length
Tidsramme: Data collection occurred before and immediately after each training session
Stride Length was measured in centimeters
Data collection occurred before and immediately after each training session
Gait Velocity
Tidsramme: Data collection occurred before and immediately after each training session
Gait Velocity was measured in meters per second
Data collection occurred before and immediately after each training session
Cadence
Tidsramme: Data collection occurred before and immediately after each training session
Cadence was measured in steps per minute
Data collection occurred before and immediately after each training session
Number of Steps to Regain Balance
Tidsramme: Data collection occurred before and immediately after each training session
Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.
Data collection occurred before and immediately after each training session
First Step Length
Tidsramme: Data collection occurred before and immediately after each training session
First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.
Data collection occurred before and immediately after each training session
First Step Velocity
Tidsramme: Data collection occurred before and immediately after each training session
First step velocity was measured in meters per second
Data collection occurred before and immediately after each training session

Samarbejdspartnere og efterforskere

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

Sponsor

University of Maryland, Baltimore

Efterforskere

  • Ledende efterforsker: Gad Alon, PhD, PT, University of Maryland, Baltimore
  • Ledende efterforsker: Mark W Rogers, PhD, PT, University of Maryland, Baltimore
  • Ledende efterforsker: Lisa Shulman, MD, Univeristy of Maryland, Baltimore

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. januar 2010

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

19. marts 2010

Først indsendt, der opfyldte QC-kriterier

8. april 2010

Først opslået (Skøn)

9. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HP-00040670

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cranial Electric Stimulation (CES)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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