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Active, not recruiting Not applicable

Paired Associative Stimulation (PAS) for Stroke Rehabilitation

NCT07691099 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2019-11-10
Last updated
2026-07-08

Condition(s) studied

Stroke Ischemic

Investigational drug(s) / intervention(s)

A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)

A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel): 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).

A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel): 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.

Study summary

Paired associative stimulation (PAS) delivered with multi-channel deep transcranial magnetic stimulation (dTMS) may enhance motor recovery in patients with first-ever ischemic stroke. This study evaluates whether dTMS-PAS targeting both primary motor cortices (M1-M1) improves upper-extremity hemiparesis when administered at the early subacute stage (up to three weeks poststroke).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score — From enrollment to one year after enrollment
    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.

Trial sites (1)

FacilityCityRegionStatus
Soroke University Medical Center Beersheba Israel
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07691099 on ClinicalTrials.gov ↗ ← All trials in Israel