Paired Associative Stimulation (PAS) for Stroke Rehabilitation (PAS-Stroke)
Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Motor Impairement in Stroke Patients
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Beersheba, Izrael
- Soroke University Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- The diagnosis of stroke is based on computed tomography (CT) or magnetic resonance imaging (MRI).
- The diagnosis of first acute ischemic stroke in unilateral hemisphere within 3 weeks after onset.
- Clinically evident arm hemiparesis attributable to acute ischemic stroke.
- Age of 18-85 years.
- The ability to sign a informed consent.
Exclusion Criteria:
- Any previous stroke.
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- Prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial.
- Current participation in another study with an investigational drug or device.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months prior to participation in the current study.
- Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
- Intracranial aneurysm, unless surgically or endovascularlytreated more than 3 months prior to participation in the current study.
- Seizure at the onset of stroke or a history of epilepsy.
- Life expectancy less than 3 months.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Other serious illness, e.g., severe hepatic, cardiac, or renal failure.
- Acute myocardial infarction or complex disease that may confound treatment assessment.
- Cognitive or verbal impairment that prevented understanding of or cooperation with the research study.
Under the following medical conditions, treatment was stopped, and patients were excluded from the study:
- Acute worsening of > 4 points on the NIH stroke scale (NIHSS).
- Acute symptoms of headache nausea and vomiting suggestive of possible sICH.
- Occurrence of seizures.
- Appearance of a new ventricular arrhythmia, tachycardia, fibrillation etc. or a new life-threatening supraventricular arrhythmia (e.g., rapid atrial fibrillation or supraventricular tachycardia).
- Symptomatic bradycardia - heart rate less than 50 beats per min.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Active PAS protocol
120% of individual unaffected-hemisphere (UH) resting motor threshold (RMT)
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Active dTMS-PAS stimulation is applied at 120% of the individual RMT of the UH.
Each session consists of 600 paired pulses, delivered bilaterally over M1-M1, with an inter-pulse interval (IPI) of 10 miliseconds (ms) and an inter-stimulus interval (ISI) of 3 seconds (s), for a total duration of 30 minutes (m).
Sham PAS is delivered using the same coil, applied at 40% of the individual RMT of the UH.
Each session consists of identical number of paired pulses and timing parameters as in the Active PAS arm, but at an intensity insufficient to induce cortical modulation.
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Falešný srovnávač: Sham PAS protocol
40% of individual UH RMT
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Active dTMS-PAS stimulation is applied at 120% of the individual RMT of the UH.
Each session consists of 600 paired pulses, delivered bilaterally over M1-M1, with an inter-pulse interval (IPI) of 10 miliseconds (ms) and an inter-stimulus interval (ISI) of 3 seconds (s), for a total duration of 30 minutes (m).
Sham PAS is delivered using the same coil, applied at 40% of the individual RMT of the UH.
Each session consists of identical number of paired pulses and timing parameters as in the Active PAS arm, but at an intensity insufficient to induce cortical modulation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score
Časové okno: From enrollment to one year after enrollment
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The FMA-UE is a standardized, clinical, stroke-specific performance scale assessing motor impairement of the upper-extremity. It includes 33 items across four domains (shoulder-arm, wrist, hand, coordination), each scored 0-2 (total range 0-66). Higher scores indicate better motor function. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke. |
From enrollment to one year after enrollment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Action Research Arm Test (ARAT) Score
Časové okno: From enrollment to one year after enrollement
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The ARAT is a standardized clinical measure of arm-hand functional capacity consisting of 19 items across grasp, pinch, and gross movement (score range 0-57). Higher scores indicate better function. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke. |
From enrollment to one year after enrollement
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Jebsen-Taylor Hand Function Test (JTHFT) Time
Časové okno: From enrollement to one year after enrollment
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The JTHFT is a standardized clinical 7-task timed assessment of functional hand performance (writing, page turning, object lifting, etc.). Each task is scored by the time required to complete it, with a maximum allowed time of 120 seconds per task. Lower total time indicates better function. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke. |
From enrollement to one year after enrollment
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Box and Blocks Test (BBT) Score
Časové okno: From enrollement to one year after enrollement
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The BBT is a standardized clinical measure, assessing unilateral manual dexterity by counting the number of blocks transferred in 60 seconds. Higher values indicate greater dexterity. Normative reference values are available by age, sex, and hand dominance, allowing interpretation relative to typical performance. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke. |
From enrollement to one year after enrollement
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Hand-Held Dynamometry Grip Strength
Časové okno: From enrollement to one year after enrollment
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Grip strengh is assessed using a standardized clinical hand-held dynamometer, which provides an objective numerical measure of upper-extremity muscle strength. Higher values indicate greater strength. Normative reference values are available by age, sex, and hand dominance, allowing interpretation relative to typical performance. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke. |
From enrollement to one year after enrollment
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Disabilities of the ARM, Shoulder, and Hand (DASH) Score
Časové okno: From enrollement to one year after enrollment
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The DASH is a 30-item self-report questionnaire assessing upper-extremity disability (0-100%). Higher scores indicate greater disability. Assessment Schedule: Pre-treatment, Post-treatment, 2 and 12 months. |
From enrollement to one year after enrollment
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Resting Motor Threshold (RMT) via transcranial magnetic stimulation (TMS)
Časové okno: From enrollment to one year after enrollment
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RMT is the minimum TMS intensity required to elicit a measurable electromyography (EMG) response in the abductor pollicis brevis. Lower thresholds indicate higher corticospinal excitability. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke.; plus pre- and post-protocol measurements during the first two PAS sessions. |
From enrollment to one year after enrollment
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Motor evoked potential (MEP) Amplitude
Časové okno: From enrollement to one year after enrollment
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MEP amplitude (peak-to-peak EMG response) reflects corticospinal excitability following TMS. Higher amplitudes indicate greater excitability. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke.; plus pre- and post-protocol measurements during the first two PAS sessions. |
From enrollement to one year after enrollment
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MEP Latency
Časové okno: From enrollment to one year after enrollment
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Latency is the time from TMS pulse to the initial MEP peak, reflecting conduction speed. Shorter latency indicated faster neural conduction. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke.; plus pre- and post-protocol measurements during the first two PAS sessions. |
From enrollment to one year after enrollment
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Interhemispheric inhibition (IHI) via PAS
Časové okno: From enrollment to one year after enrollment
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IHI quantifies inhibitory influence from one motor cortex to the other using PAS. Greater inhibition reflects stronger interhemispheric suppression. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke; plus pre- and post-protocol measurements during the first two PAS sessions. |
From enrollment to one year after enrollment
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0270-19-SOR
- MOH_2018-06-07_002349 (Identifikátor registru: Israeli Ministry of Health Research Ethics Board)
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