- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01414582
Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)
Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Vaihe 2
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Oxford, Yhdistynyt kuningaskunta
- Rekrytointi
- Centre for Functional MRI of the Brain (FMRIB)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Huijausvertailija: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Fugl Meyer Assessment of Motor Recovery following Stroke
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Reaction Time Test
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 10/H0604/98
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Kliiniset tutkimukset Aivohalvaus
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Hospital Central Sur de Alta EspecialidadTuntematonAivohalvaus | National Institutes of Health Stroke Scale | Seerumin erittäin herkkä C-reaktiivinen proteiiniMeksiko
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TakedaValmisPost-Stroke Cognitive Impairment (PSCI)Valko-Venäjä, Kazakstan, Venäjän federaatio
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University of LeicesterUniversity Hospitals, Leicester; British Heart FoundationRekrytointiLacunar StrokeYhdistynyt kuningaskunta
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National Yang Ming UniversityValmisAivohalvaus | Krooninen aivohalvaus | Spastisuus Post StrokeTaiwan
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Second Affiliated Hospital, School of Medicine,...Ei vielä rekrytointiaAkuutti iskeeminen aivohalvaus | Laadun parantaminen | Stroke RecrudescenceKiina
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University of EdinburghEi vielä rekrytointiaAivojen pienten alusten sairaudet | Vaskulaarinen dementia | Lacunar Stroke
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University of CambridgeCambridge University Hospitals NHS Foundation Trust; Wolfson Brain Imaging...RekrytointiAivojen pienten alusten sairaudet | Aivopienten verisuonten iskeeminen sairaus | Lacunar StrokeYhdistynyt kuningaskunta
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Universidade do Vale do ParaíbaTuntematonLeikkaus | Selkärangan vammat | Posttraumaattinen päänsärky | Skleroosi, Multippeli | Post Stroke | Aivovamma, spastinen | SpastinenBrasilia
Kliiniset tutkimukset Anodal tDCS
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Riphah International UniversityValmisAivohalvausPakistan
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School of Health Sciences GenevaUniversity Hospital, GenevaRekrytointiAivohalvaus | Kävely, hemipleginenSveitsi
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Sheffield Hallam UniversityValmisKognitiivinen joustavuusYhdistynyt kuningaskunta
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Hôpital le VinatierValmisSkitsofrenia | KuulohalusinaatiotRanska, Tunisia
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Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta...Ilmoittautuminen kutsusta
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Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)Tuntematon
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)ValmisMotorinen toiminta | Motorinen neuroplastisuusYhdysvallat
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Charite University, Berlin, GermanyValmisMigreeni Auran kanssa | CADASIL | Aivojen mikroangiopatia | ICA-stenoosiSaksa
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Bambino Gesù Hospital and Research InstituteValmis
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Thorsten RudroffLopetettuMultippeliskleroosi | Neuropaattinen kipuYhdysvallat