Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
28. října 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
10
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- PTRS Research Lab
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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)
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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.
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Stride Length
Časové okno: Data collection occurred before and immediately after each training session
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Stride Length was measured in centimeters
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Data collection occurred before and immediately after each training session
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Gait Velocity
Časové okno: Data collection occurred before and immediately after each training session
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Gait Velocity was measured in meters per second
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Data collection occurred before and immediately after each training session
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Cadence
Časové okno: Data collection occurred before and immediately after each training session
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Cadence was measured in steps per minute
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Data collection occurred before and immediately after each training session
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Number of Steps to Regain Balance
Časové okno: Data collection occurred before and immediately after each training session
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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.
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Data collection occurred before and immediately after each training session
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First Step Length
Časové okno: Data collection occurred before and immediately after each training session
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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.
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Data collection occurred before and immediately after each training session
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First Step Velocity
Časové okno: Data collection occurred before and immediately after each training session
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First step velocity was measured in meters per second
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Data collection occurred before and immediately after each training session
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Gad Alon, PhD, PT, University of Maryland, Baltimore
- Vrchní vyšetřovatel: Mark W Rogers, PhD, PT, University of Maryland, Baltimore
- Vrchní vyšetřovatel: Lisa Shulman, MD, Univeristy of Maryland, Baltimore
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2010
Primární dokončení (Aktuální)
1. června 2011
Dokončení studie (Aktuální)
1. června 2011
Termíny zápisu do studia
První předloženo
19. března 2010
První předloženo, které splnilo kritéria kontroly kvality
8. dubna 2010
První zveřejněno (Odhad)
9. dubna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. října 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. října 2019
Naposledy ověřeno
1. října 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HP-00040670
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .