Paired Associative Stimulation (PAS) for Stroke Rehabilitation

NCT07691099 | Active Not Recruiting

• 2 other identifiers: 0270-19-SORMOH_2018-06-07_002349
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stroke Ischemic

Keywords

Stroke; Upper-extremity; Hemiparesis; Paired Associative Stimulaton; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score

  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

Secondary Outcomes (9)

• Action Research Arm Test (ARAT) Score

  From enrollment to one year after enrollement

• Jebsen-Taylor Hand Function Test (JTHFT) Time

  From enrollement to one year after enrollment

• Box and Blocks Test (BBT) Score

  From enrollement to one year after enrollement

• Hand-Held Dynamometry Grip Strength

  From enrollement to one year after enrollment

• Disabilities of the ARM, Shoulder, and Hand (DASH) Score

  From enrollement to one year after enrollment

Study Arms (2)

Active PAS protocol

EXPERIMENTAL

120% of individual unaffected-hemisphere (UH) resting motor threshold (RMT)

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

Sham PAS protocol

SHAM COMPARATOR

40% of individual UH RMT

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

Interventions

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

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).

Active PAS protocol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Ben-Gurion University of the Negev: collaborator
• Soroka University Medical Center: lead

Study Sites (1)

Soroke University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Department

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: July 8, 2026
• Study Start: November 10, 2019
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)