- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00715520
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Aims 1 and 2
Inclusion Criteria:
- Normal neurological examination
- Ability to meet criteria of inclusion experiment
- Ability to give informed consent.
Exclusion Criteria:
- History or neurological or psychiatric disease
- Abnormal MRI of brain
- Abnormal neuropsychological testing
- Intake of CNS active drugs
- History of seizure disorder
- History of migraine headaches
- History of anaphylaxis or allergic reactions
- Contraindication to TMS
Aim 3:
Inclusion Criteria:
- Cerebral ischemic infarction more than 6 months prior to entering the study
- Single lesion as defined by MRI of the brain affecting the primary motor output system of the hand at a cortical (M1) level or subcortical level, or unilateral, and supratentorial in absence of history of a previous symptomatic stroke within 3 months of the current stroke
- Dense paresis of the hand for more than three days after cerebral infarction (MRC of < 4- of wrist- and finger extension/flexion movements)
- Good functional recovery of hand function as defined by MRC of 4 or 4+ of wrist- and finger extension/flexion movements
- Ability to perform wrist extension movements
- Ability to meet criteria of inclusion experiment
- Ability to give informed consent
- Ability of TMS to elicit a measurable MEP of > 100 μV and an increase in MEP amplitude with increasing stimulus intensity (up to 100% of MSO) of at least 20% over MEP amplitude at MT
Exclusion Criteria:
- History or neurological or psychiatric disease, including bipolar disorder
- Intake of CNS active drugs
- History of seizure disorder
- History of migraine headaches
- History of anaphylaxis or allergic reactions
- Contraindication to TMS
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Aim 1
Healthy adult female and male subjects will receive study drugs and TMS training to measure M1 excitability.
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Participants will receive one oral dose of carbidopa-levodopa 25mg one hour prior to measuring wrist extension movements. The order in which Carbidopa-Levodopa is given will be randomized per participant.
Otros nombres:
Participants will receive one oral dose of methylphenidate 40mg 2 hours prior to measuring wrist extension movements. The order in which Methylphenidate is given will be randomized per participant. Participants will receive one oral dose of amphetamine sulfate 10mg 2 hours prior to measuring wrist extension movements. The order in which Amphetamine Sulfate is given will be randomized per participant. Participants will receive one oral tablet of placebo 2 hours prior to measuring wrist extension movements. The order in which Placebo is given will be randomized per participant.
TMS surface electromyographic activity will be recorded with surface electrodes mounted on the skin overlaying a forearm muscle.
Single pulses of TMS at increasing intensity will be delivered to measure motor cortex excitability.
Peak acceleration and TMS evoked responses in the muscle will be measured prior to the training, after completion of the training and again one hour after completion of the training.
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Experimental: Aim 2
Healthy adult female and male subjects will receive repetitive TMS (rTMS) at different times or frequencies with respect to the training movement or sham stimulation.
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Each TMS training session will begin with a baseline measurement lasting about 30 minutes in which brief magnetic pulses will be generated by the single-pulse and paired pulse TMS stimulator and the responses are recorded with surface EMG electrodes.
Participants will be instructed to move their wrist for up to ½ hour.
After these measures, rTMS will be applied to the scalp during training.
Stimulation will occur at a low rate of different frequencies and different times with respect to the training movement depending on the experimental condition.
In the last phase of the session post-training measurements will be done using single TMS pulses.
TMS pulses and intensity with be given in random order.
Sham TMS pulses will be randomly administered during TMS sessions.
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Experimental: Aim 3
Female and male subjects who have experienced a cerebral ischemic infarction, will receive study drugs and TMS to measure M1 excitability.
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Participants will receive one oral dose of carbidopa-levodopa 25mg one hour prior to measuring wrist extension movements. The order in which Carbidopa-Levodopa is given will be randomized per participant.
Otros nombres:
Participants will receive one oral dose of methylphenidate 40mg 2 hours prior to measuring wrist extension movements. The order in which Methylphenidate is given will be randomized per participant. Participants will receive one oral dose of amphetamine sulfate 10mg 2 hours prior to measuring wrist extension movements. The order in which Amphetamine Sulfate is given will be randomized per participant. Participants will receive one oral tablet of placebo 2 hours prior to measuring wrist extension movements. The order in which Placebo is given will be randomized per participant.
TMS surface electromyographic activity will be recorded with surface electrodes mounted on the skin overlaying a forearm muscle.
Single pulses of TMS at increasing intensity will be delivered to measure motor cortex excitability.
Peak acceleration and TMS evoked responses in the muscle will be measured prior to the training, after completion of the training and again one hour after completion of the training.
Sham TMS pulses will be randomly administered during TMS sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Periodo de tiempo: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity.
Its amplitude is measured from peak to peak and expressed in millivolts (mV).
Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC).
SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted.
Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
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Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 1: Mean Peak Acceleration of Wrist Extension Movements
Periodo de tiempo: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
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Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Its amplitude is measured from peak to peak and expressed in mV.
Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
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Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
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Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
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Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
|
Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
|
Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity.
Its amplitude is measured from peak to peak and expressed in millivolts (mV).
Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC).
SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted.
Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.
|
Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
|
Aim 3: Mean Peak Acceleration of Wrist Extension Movements
Periodo de tiempo: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
|
Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3).
Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.
Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.
|
Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cathrin M Buetefisch, MD, Emory University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Carrera
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Factores inmunológicos
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agonistas de dopamina
- Agentes de dopamina
- Adyuvantes, Inmunológicos
- Inhibidores de la captación de dopamina
- Estimulantes del Sistema Nervioso Central
- Simpaticomiméticos
- Inhibidores de la captación adrenérgica
- Agentes antiparkinsonianos
- Agentes contra la discinesia
- Inhibidores de la descarboxilasa de aminoácidos aromáticos
- Metilfenidato
- Levodopa
- Anfetamina
- Carbidopa
- Combinación de fármacos carbidopa y levodopa
Otros números de identificación del estudio
- IRB00046953
- R01NS060830-01A1 (Subvención/contrato del NIH de EE. UU.)
- NPARR01 (Otro identificador: Other)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .