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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Beersheba, Israel
- Soroke University Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Sham-komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Action Research Arm Test (ARAT) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0270-19-SOR
- MOH_2018-06-07_002349 (Registry Identifier: Israeli Ministry of Health Research Ethics Board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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