An interventional study of A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) and A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) in Stroke Ischemic, sponsored by Soroka University Medical Center. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
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).
Unilateral ischemic stroke disrupts the activity balance between the hemispheres, which hinder brains' recovery and treatments' efficiency. The most common and pervasive acquired postischemic stroke functional disorder is hemiparesis of the upper-extremity. The limited impact of conventional rehabilitation therapies is attributed to their inability to restore the interhemispheric balance. Thus, PAS protocol, delivered using dTMS, may benefit patients by regaining the interhemispheric balance. PAS is delivered over two different cortical brain areas, and the modulation of interhemispheric balance is determined by which area is stimulated by the first pulse and which by the second. In this study, the investigators apply a dTMS-PAS protocol over the two primary motor cortices, to restore the activity balance between M1-M1, alleviate upper-extremity hemiparesis symptoms, and promote functional recovery.
Exclusion Criteria:
Under the following medical conditions, treatment was stopped, and patients were excluded from the study:
120% of individual unaffected-hemisphere (UH) resting motor threshold (RMT)
Device: A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)
40% of individual UH RMT
Device: 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).
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.
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.
Time frame: From enrollment to one year after enrollment
Action Research Arm Test (ARAT) Score
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.
Time frame: From enrollment to one year after enrollement
Jebsen-Taylor Hand Function Test (JTHFT) Time
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.
Time frame: From enrollement to one year after enrollment
Box and Blocks Test (BBT) Score
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.
Time frame: From enrollement to one year after enrollement
Hand-Held Dynamometry Grip Strength
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.
Time frame: From enrollement to one year after enrollment
Disabilities of the ARM, Shoulder, and Hand (DASH) Score
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.
Time frame: From enrollement to one year after enrollment
Resting Motor Threshold (RMT) via transcranial magnetic stimulation (TMS)
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.
Time frame: From enrollment to one year after enrollment
Motor evoked potential (MEP) Amplitude
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.
Time frame: From enrollement to one year after enrollment
MEP Latency
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.
Time frame: From enrollment to one year after enrollment
Interhemispheric inhibition (IHI) via PAS
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.
Time frame: From enrollment to one year after enrollment
Plan to share: Yes
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Soroka University Medical Center