Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)
19 czerwca 2012 zaktualizowane przez: University of Oxford
Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation
This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.
Przegląd badań
Status
Nieznany
Interwencja / Leczenie
Szczegółowy opis
Previous research that utilises single sessions of tDCS have demonstrated functional improvements; however, these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. It has been suggested that repeated stimulation sessions are required to elicit long-lasting improvements. We aim to consider these details over the duration of this research, during which patients with chronic stroke will attend for 16 sessions over the course of 3 months.
This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
80
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Oxford, Zjednoczone Królestwo
- Rekrutacyjny
- Centre for Functional MRI of the Brain (FMRIB)
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 - 80 years.
- Patients should be at least six months post first symptomatic stroke affecting motor function of the hand.
Exclusion Criteria:
- Anyone who does not have adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms.
- Anyone who has a previous history of epilepsy, febrile convulsions as a child or recurrent fainting fits. Likewise, anyone who has a significant family history of epilepsy would be excluded as all these conditions carry a theoretical risk of increasing susceptibility to seizures.
- Any person who has a history of drug abuse or a previous history of a neurological or psychiatric illness, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
- Patients on some prescription medications such as anti-depressants may be excluded as they may be at an increased risk of seizures.
- Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours.
- Pregnant women are excluded as a precaution as there is no data on the effect on maternal cranial stimulation on the fetus.
- Any metallic implant in the neck, head, or eye and anyone with any implanted electrical devices would be excluded as there is a risk of heating with both TMS and TDCS stimulation.
- Anyone with any metal implants or implantable device would be excluded as indicated by the MRI safety screening form. People who suffer with claustrophobia as they are unable to tolerate the scanner.
- Patients who have had more than one stroke. Patients who have had a stroke will also be excluded if they have limited communication in the form of aphasia or a history of dementia.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Anodal tDCS and Motor Training
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere.
The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
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Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere.
The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
All participants will receive a standardised motor training intervention for the upper paretic limb
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Pozorny komparator: Sham tDCS and Motor Training
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
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All participants will receive a standardised motor training intervention for the upper paretic limb
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Fugl Meyer Assessment of Motor Recovery following Stroke
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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Wolf Motor Function Test
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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Action Research Arm Test
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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9 Hole Peg Test
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Reaction Time Test
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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Stroke Impact Scale
Ramy czasowe: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2011
Zakończenie podstawowe (Oczekiwany)
1 grudnia 2013
Ukończenie studiów (Oczekiwany)
1 grudnia 2013
Daty rejestracji na studia
Pierwszy przesłany
4 sierpnia 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 sierpnia 2011
Pierwszy wysłany (Oszacować)
11 sierpnia 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
20 czerwca 2012
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 czerwca 2012
Ostatnia weryfikacja
1 czerwca 2012
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 10/H0604/98
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