Stroke IschemicPAS-StrokeNCT07691099
Paired Associative Stimulation (PAS) for Stroke Rehabilitation
A study testing A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) in people with Stroke Ischemic, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke Ischemic
- What is being tested?
- A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Nov 2019to 28 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Motor Impairement in Stroke Patients
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).
Read the detailed description
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.
- Conditions
- Stroke Ischemic
- Being tested
- A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)
- Keywords
- Stroke, Upper-extremity, Hemiparesis, Paired Associative Stimulaton, Rehabilitation
- Medical subject headings
- Ischemic Stroke, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)Device
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 group | Role | What they receive |
|---|---|---|
| Active PAS protocol | Experimental | 120% of individual unaffected-hemisphere (UH) resting motor threshold (RMT) Receives: Device: A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) |
| Sham PAS protocol | Sham comparator | 40% of individual UH RMT Receives: Device: A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to one year after enrollment
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start10 Nov 2019
- Primary completion15 Apr 2026
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Iuly Treger MD, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691099
- Sponsor's protocol ID
- 0270-19-SOR
- Other IDs
- MOH_2018-06-07_002349
- Acronym
- PAS-Stroke
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Motor Impairement in Stroke Patients
- ClinicalTrials.gov ID
- NCT07691099
- Acronym / sponsor ID
- PAS-Stroke / 0270-19-SOR
- Conditions
- Stroke Ischemic
- Keywords
- Stroke, Upper-extremity, Hemiparesis, Paired Associative Stimulaton, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PAS protocol | Experimental | Device: A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)120% of individual unaffected-hemisphere (UH) resting motor threshold (RMT) |
| Sham PAS protocol | Sham comparator | Device: A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel)40% of individual UH RMT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Active PAS protocol |
| 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. | Device | Sham PAS protocol |
Primary outcome
Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score
Time frame: 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.
9 secondary outcomes
Action Research Arm Test (ARAT) Score
Time frame: From enrollment to one year after enrollement
Jebsen-Taylor Hand Function Test (JTHFT) Time
Time frame: From enrollement to one year after enrollment
Box and Blocks Test (BBT) Score
Time frame: From enrollement to one year after enrollement
Hand-Held Dynamometry Grip Strength
Time frame: From enrollement to one year after enrollment
Disabilities of the ARM, Shoulder, and Hand (DASH) Score
Time frame: From enrollement to one year after enrollment
Resting Motor Threshold (RMT) via transcranial magnetic stimulation (TMS)
Time frame: From enrollment to one year after enrollment
Motor evoked potential (MEP) Amplitude
Time frame: From enrollement to one year after enrollment
MEP Latency
Time frame: From enrollment to one year after enrollment
Interhemispheric inhibition (IHI) via PAS
Time frame: From enrollment to one year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multi-channel device with deep TMS coil (Brainsway Ltd., Jerusalem, Israel) in people with Stroke Ischemic, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score (time frame: From enrollment to one year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.