- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00715520
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
Przegląd badań
Status
Warunki
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University School of Medicine
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
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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Eksperymentalny: 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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Eksperymentalny: 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.
Inne nazwy:
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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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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)
Ramy czasowe: 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.
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Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Aim 3: Mean Peak Acceleration of Wrist Extension Movements
Ramy czasowe: 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.
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Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Cathrin M Buetefisch, MD, Emory University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu krążenia
- Choroby naczyniowe
- Zaburzenia naczyniowo-mózgowe
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Uderzenie
- Fizjologiczne skutki leków
- Środki adrenergiczne
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenci autonomiczni
- Agenty obwodowego układu nerwowego
- Inhibitory enzymów
- Czynniki immunologiczne
- Inhibitory wychwytu neuroprzekaźników
- Modulatory transportu membranowego
- Agoniści dopaminy
- Agentów dopaminy
- Adiuwanty, immunologiczne
- Inhibitory wychwytu dopaminy
- Stymulatory ośrodkowego układu nerwowego
- Sympatykomimetyki
- Inhibitory wychwytu adrenergicznego
- Agenci przeciw parkinsonowi
- Agenci przeciwko Dyskinezie
- Inhibitory dekarboksylazy aminokwasów aromatycznych
- Metylofenidat
- Lewodopa
- Amfetamina
- Karbidopa
- Karbidopa, kombinacja leków z lewodopą
Inne numery identyfikacyjne badania
- IRB00046953
- R01NS060830-01A1 (Grant/umowa NIH USA)
- NPARR01 (Inny identyfikator: Other)
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