- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00001661
Mechanisms of Human Plasticity in the Human System
Mechanisms of Plasticity in the Human Motor System
The purpose of this study is to investigate the physiology associated with plasticity of the motor system. Plasticity refers to the process by which neighboring brain cells assume the responsibilities of damaged or diseased brain cells.
The mechanisms behind this process are unknown. However, researchers have several theories about how plastic changes take place. Possible explanations include the growth of new connections between brain cells and the use of previously unused connections.
Researchers plan to use transcranial magnetic stimulation and drug intervention in order to determine the mechanisms responsible for specific types of plasticity.
Previous studies have shown that certain drugs can affect the mechanisms involved in these changes. By using one drug at a time, researchers plan to evaluate the role of each of several different mechanisms in brain reorganization.
Studieoversikt
Status
Detaljert beskrivelse
The purpose of this study is to investigate the physiology associated with plasticity of the motor system seen in a number of different circumstances. Techniques used will involve the combination of transcranial magnetic stimulation (TMS) and pharmacologic interventions. We propose to use drugs judged to be safe, that either potentiate GABA related intracortical inhibition, change presynaptic release of excitatory aminoacids like glutamate, or decrease the activity of the NMDA receptors (mostly antiepileptic drugs). If plastic changes expressed as larger motor maps or motor evoked potentials (MEP) to TMS are secondary to intracortical disinhibition, administration of a drug that potentiates intracortical inhibition may result in decreased plasticity and smaller motor maps or MEP. This finding would then identify intracortical disinhibition as the mechanism responsible for this type of plasticity. Similarly, if plastic changes decrease with a drug that inhibits release of excitatory aminoacids, or that antagonize the action of NMDA receptors, the mechanism underlying plasticity is likely to be mediated by modulation in the release of excitatory aminoacids or activity in NMDA-receptors.
Results from this study will then provide information about the relative involvement of intracortical disinhibition, modulation in the release of excitatory aminoacids, and role of NMDA receptors in different settings of human plasticity.
Studietype
Registrering
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
Must be over 18 years of age.
Must not have personal history of seizures, loss of consciousness, hypertension, psychosis, heart conditions or allergies to any of the drugs.
Women must not be nursing or pregnant.
Patients may have amputations, spinal cord injuries, blindness or large hemispheric lesions from stroke.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
- Ziemann U, Lonnecker S, Steinhoff BJ, Paulus W. Effects of antiepileptic drugs on motor cortex excitability in humans: a transcranial magnetic stimulation study. Ann Neurol. 1996 Sep;40(3):367-78. doi: 10.1002/ana.410400306.
- Brasil-Neto JP, Valls-Sole J, Pascual-Leone A, Cammarota A, Amassian VE, Cracco R, Maccabee P, Cracco J, Hallett M, Cohen LG. Rapid modulation of human cortical motor outputs following ischaemic nerve block. Brain. 1993 Jun;116 ( Pt 3):511-25. doi: 10.1093/brain/116.3.511.
Studierekorddatoer
Studer hoveddatoer
Studiestart
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
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Øyesykdommer
- Nevrologiske manifestasjoner
- Sår og skader
- Traumer, nervesystemet
- Ryggmargssykdommer
- Sensasjonsforstyrrelser
- Synsforstyrrelser
- Slag
- Ryggmargsskader
- Blindhet
Andre studie-ID-numre
- 970048
- 97-N-0048
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