- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00028379
Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke
Recent studies have demonstrated that electrical stimulation delivered over the skin increases the muscle strength as measured by a dynamometer in chronic stroke patients. We recently also found out that such stimulation enhances the ability of healthy brains to learn faster, enhancing the beneficial effects of the motor training.
The purpose of this study is to find out if this stimulation can enhance the ability of stroke patients to experience plastic changes in the brain. It may aid in the development of new strategies for rehabilitation after brain injury in the future.
A clinical and neurological exam will be administered. Each patient will participate in three different sessions separated by at least 48 hours: a 2-hour peripheral nerve stimulation to the weak hand, a 2-hour peripheral nerve stimulation to the leg, and no stimulation. The sessions will be randomly ordered. A magnetic resonance imaging scan of the brain will be done as well.
Nerve stimulation will be done by transcranial magnetic stimulation (TMS). In TMS, the head is immobilized within a frame. An insulated coil wire is placed on the scalp and brief electrical current passed through it. Participants may be asked to perform movements, do simple tasks, or simply tense muscles. Electrical activity of the muscles will be recorded with a computer. Some experiments may be recorded on videotape.
Participants must be stroke patients who have recovered to the point of being able to make thumb movements, and the stroke must have occurred more than 6 months ago.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
INCLUSION CRITERIA:
Hemiparetic patients (right or left who had thromboembolic non-hemorrhagic infarction (documented by CT or MRI) more than 6 months before. Patients should have recovered motor function to the point of being able to perform thumb movements.
Patients will be recruited from referrals from the community, particularly Baltimore and Washington VA hospitals, and Suburban Hospital as well as stroke clubs. An anatomical MRI scan will be acquired at the NIH if a recent one (within 6 months) is not available.
EXCLUSION CRITERIA:
- Large hemorrhagic or brain stem stroke.
- Multiple cerebral lesions with residual deficits.
- History of head injury with loss of consciousness.
- History of severe alcohol or drug abuse.
- History of psychiatric illness.
- Unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg).
- H/o hyperthyroidism.
- Receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine,prazosin, phenytoin, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates.
- Degree of aphasia or cognitive deficit that makes patient unable to give informed consent.
- Pregnancy, glaucoma, h/o hypersensitivity or idiosyncrasy to sympatomimetic drugs.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Aschersleben G, Gehrke J, Prinz W. Tapping with peripheral nerve block. a role for tactile feedback in the timing of movements. Exp Brain Res. 2001 Feb;136(3):331-9. doi: 10.1007/s002210000562.
- Barker AT, Freeston IL, Jalinous R, Jarratt JA. Magnetic stimulation of the human brain and peripheral nervous system: an introduction and the results of an initial clinical evaluation. Neurosurgery. 1987 Jan;20(1):100-9. doi: 10.1097/00006123-198701000-00024.
- Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 020082
- 02-N-0082
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Kliniske studier på Cerebrovaskulær ulykke
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Bioness IncUniversity of Cincinnati; Medidata SolutionsFullførtGang, slippfot | Sensorimotorisk gangforstyrrelse | Nevrologisk ambulasjonslidelse | Hemiparese etter slag | Post-Cerebrovaskulær Accident (CVA) HemipareseForente stater
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