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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb.
This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks.
The study will include the following site visits:
In a pilot, randomized clinical trial, 24 stroke patients with moderate/severe impairments will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or rTMS) to one of two targets in the brain in conjunction with upper limb training for 2 days a week for 6 weeks. The primary outcome will be upper limb motor impairment, and secondary outcomes will be tests of functional abilities, proximal motor control, and patient-reported disability. Associated neural mechanisms will also be studied using neurophysiological and functional connectivity MRI techniques. Damage to ipsilesional corticospinal pathways will be indexed with diffusion tensor imaging (DTI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contralesional dorsal premotor cortex (cPMD) rTMS + Training | Active Comparator | New Approach |
|
| Ipsilesional Primary Motor Cortex (iM1) rTMS + Training | Active Comparator | Conventional Approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Repetitive Magnetic Stimulation (rTMS) Approach | Device | Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Fugyl-Meyer Score (UEFM) | Change between Baseline and Post-Test (average 6 weeks) is reported for the UEFM. Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's α= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional limitation of the paretic arm.) | Change between Baseline and Post-Test (average 6 weeks) |
| Change in Inter-hemispheric Inhibition (IHI) | Inter-hemispheric connectivity (IHI) will be collected with transcranial magnetic stimulation (TMS) and is assessed using ipsilateral silent period (ISP) method. TMS is delivered to the contralesional motor hotspot at supra-maximal intensity (100% maximum stimulator output) while participants maintain sub-maximal contraction (50% maximum volitional contraction) of the ipsilateral paretic extensor digitorum communis muscle for 40 trials. Ipsilateral TMS produces transient suppression of on-going EMG activity, called ISP. ISP is analyzed using an algorithm that compares psotstimulus average rectified EMG to mean consecutive difference (MCD) of background EMG. A threshold of MCD x1.77 below mean background EMG is used to define ISP onset and offset. ISP duration is then calculated as a difference between onset and offset of the ISP. | Change between Baseline and Post-Test (average 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wolf Motor Function Test (WMFT) Functional Ability | Change in Functional Ability (FA) from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Functional ability (FA) to use the paretic upper limb in a variety of tasks will be assessed using WMFT. FA is scored on a scale from 0-5 with 0 not attempting the task at all and 5 being completely normal movement compared to non paretic limb. 15 items of WMFT are given a FA for the Paretic limb and then the score is averaged to give an overall FA for each participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ela Plow, PhD | Lerner Research Institute; Cleveland Clinic Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lerner Research Institute; Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26484700 | Background | Cunningham DA, Varnerin N, Machado A, Bonnett C, Janini D, Roelle S, Potter-Baker K, Sankarasubramanian V, Wang X, Yue G, Plow EB. Stimulation targeting higher motor areas in stroke rehabilitation: A proof-of-concept, randomized, double-blinded placebo-controlled study of effectiveness and underlying mechanisms. Restor Neurol Neurosci. 2015;33(6):911-26. doi: 10.3233/RNN-150574. | |
| 29563050 |
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| ID | Title | Description |
|---|---|---|
| FG000 | cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training | New Approach New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
| FG001 | iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training | Conventional Approach Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adults with chronic (>6 months) unilateral upper limb motor deficits post-stroke.
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| ID | Title | Description |
|---|---|---|
| BG000 | cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training | New Approach New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Upper Extremity Fugyl-Meyer Score (UEFM) | Change between Baseline and Post-Test (average 6 weeks) is reported for the UEFM. Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's α= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional limitation of the paretic arm.) | Posted | Mean | Standard Error | change score from baseline to post-test | Change between Baseline and Post-Test (average 6 weeks) |
|
Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | cPMD rTMS + Training | New Approach New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment | headache after receiving TMS |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ela Plow | Cleveland Clinic | 216-445-6728 | plowe2@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2024 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2024 | Oct 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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In a pilot, randomized, assessor-blind clinical trial, an anticipated 24 patients will be assigned to either receive stimulation to a new brain target- contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere- or the conventional brain target- ipsilesional primary motor cortex (iM1) located in the stroke hemisphere. Stimulation will be delivered in conjunction with rehabilitation for 2 days a week for 6 weeks.
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Subjects will be told they will receive brain stimulation, but will be given no indication as to which target will be stimulated. Investigators analyzing functional outcome data, neurophysiology data and MRI data will receive coded data that conceals the identity of the subject.
|
|
| Conventional Repetitive Magnetic Stimulation (rTMS) Approach | Device | Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
|
|
| Change between Baseline and Post-Test (average 6 weeks) |
| Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb | Change in Rate of the Paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb [WMFT Rate (P)]. The higher the rate the quicker they were able to complete the task. | Change between Baseline and Post-Test (average 6 weeks) |
| Change in Wolf Motor Function Test (WMFT) Rate Non-paretic Limb | Change in Rate of the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Non-paretic limb [WMFT Rate (NP)]. The higher the rate the quicker they were able to complete the task. | Change between Baseline and Post-Test (average 6 weeks) |
| Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb Normalized to the Non-paretic Limb | Change in the normalized Rate of the Paretic limb to the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb normalized to the Non-paretic limb [WMFT Rate (P/NP)]. The higher the rate the quicker they were able to complete the task. | Change between Baseline and Post-Test (average 6 weeks) |
| Change in Stroke Impact Scale (SIS-16) | Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stoke Impact Scale (SIS-16) for each group. Patient's perceived disability related to physical function will be indexed using the Stroke Impact Scale (SIS-16) which a subjective questionnaire asked to the subject pertaining of 16 questions. Each question is rated on scale from 1 to 5 and then the scores are totaled. Total scores can range from 16-80 (16 means that none of the functional tasks asked can be performed, a score of 80 means the subject has no issues at all performing any of the tasks asked). | Change between Baseline and Post-Test (average 6 weeks) |
| Change Resting State Functional Magnetic Resonance Imaging(rsfMRI) | Functional connectivity will complement IHI measurement as a secondary outcome because while IHI records neurophysiologic interactions between a contralesional and a weak ipsilesional region, functional connectivity defines "global" interactions across multiple regions. | Change between Baseline and Post-Test (average 6 weeks) |
| Change in Ipsilateral MEPs (Motor Evoked Potentials) | Output of uncrossed pathways will be studied as ipsilateral MEPs elicited in the paretic-muscle with TMS. | Change between Baseline and Post-Test (average 6 weeks) |
| Diffusion Tensor Imaging (DTI) | Diffusion Tensor Imaging (DTI) enables the investigation of structural integrity and orientation of pathways in vivo through the estimation of magnitude and directionality of water diffusion. DTI metrics can help quantitate damage even when patients show no response to Transcranial Magnetic Stimulation (TMS) due to extensive damage (MEP-). Ipsilesional and contralesional corticospinal tracts will be reconstructed using probabilistic tractography. Fractional Anisotropy (FA), a unit-less measure of white matter integrity, will be calculated. | Baseline |
| Change in SULCS | Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stroke Upper Limb Capacity Scale (SULCS). SULCS is a stroke-specific assessment instrument that evaluates functional capacity of the upper limb based on the execution of 10 tasks. Score ranges from 0-10 where 0 is the lowest level of function in which the participant cannot perform any of the tasks as instructed and 10 is the highest level of function in which all 10 tasks are completed as instructed. | Change between Baseline and Post-Test (average 6 weeks) |
| Background |
| Potter-Baker KA, Lin YL, Machado AG, Conforto AB, Cunningham DA, Sankarasubramanian V, Sakaie K, Plow EB. Variability of motor evoked potentials in stroke explained by corticospinal pathway integrity. Brain Stimul. 2018 Jul-Aug;11(4):929-931. doi: 10.1016/j.brs.2018.03.004. Epub 2018 Mar 9. No abstract available. |
| 24951091 | Background | Plow EB, Cunningham DA, Varnerin N, Machado A. Rethinking stimulation of the brain in stroke rehabilitation: why higher motor areas might be better alternatives for patients with greater impairments. Neuroscientist. 2015 Jun;21(3):225-40. doi: 10.1177/1073858414537381. Epub 2014 Jun 20. |
| 28402865 | Result | Sankarasubramanian V, Machado AG, Conforto AB, Potter-Baker KA, Cunningham DA, Varnerin NM, Wang X, Sakaie K, Plow EB. Inhibition versus facilitation of contralesional motor cortices in stroke: Deriving a model to tailor brain stimulation. Clin Neurophysiol. 2017 Jun;128(6):892-902. doi: 10.1016/j.clinph.2017.03.030. Epub 2017 Mar 21. |
| 41707126 | Derived | Li X, Widina M, Liu J, O'Laughlin K, Barden E, Lin YL, Sakaie K, Cunningham DA, Wang X, Uchino K, Wolf SL, Conforto AB, Plow EB. Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: A Pilot Randomized Clinical Trial. Am J Phys Med Rehabil. 2026 Mar 1;105(3S Suppl 2):S64-S73. doi: 10.1097/PHM.0000000000002909. |
| 35051941 | Derived | Li X, Lin YL, Cunningham DA, Wolf SL, Sakaie K, Conforto AB, Machado AG, Mohan A, O'Laughlin K, Wang X, Widina M, Plow EB. Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial. Cerebrovasc Dis. 2022;51(5):557-564. doi: 10.1159/000521514. Epub 2022 Jan 20. |
| BG001 | iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training | Conventional Approach Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stroke Type | Count of Participants | Participants |
|
| Dominant Paresis | Count of Participants | Participants |
|
| Active wrist extension | Count of Participants | Participants |
|
| Resting Transcranial Magnetic Stimulation (TMS) Motor Evoked Potential (MEP) | Count of Participants | Participants |
|
| OG001 | iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training | Conventional Approach Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. |
|
|
| Primary | Change in Inter-hemispheric Inhibition (IHI) | Inter-hemispheric connectivity (IHI) will be collected with transcranial magnetic stimulation (TMS) and is assessed using ipsilateral silent period (ISP) method. TMS is delivered to the contralesional motor hotspot at supra-maximal intensity (100% maximum stimulator output) while participants maintain sub-maximal contraction (50% maximum volitional contraction) of the ipsilateral paretic extensor digitorum communis muscle for 40 trials. Ipsilateral TMS produces transient suppression of on-going EMG activity, called ISP. ISP is analyzed using an algorithm that compares psotstimulus average rectified EMG to mean consecutive difference (MCD) of background EMG. A threshold of MCD x1.77 below mean background EMG is used to define ISP onset and offset. ISP duration is then calculated as a difference between onset and offset of the ISP. | Posted | Mean | Standard Error | milliseconds | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change in Wolf Motor Function Test (WMFT) Functional Ability | Change in Functional Ability (FA) from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Functional ability (FA) to use the paretic upper limb in a variety of tasks will be assessed using WMFT. FA is scored on a scale from 0-5 with 0 not attempting the task at all and 5 being completely normal movement compared to non paretic limb. 15 items of WMFT are given a FA for the Paretic limb and then the score is averaged to give an overall FA for each participant. | Posted | Mean | Standard Error | units on a scale | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb | Change in Rate of the Paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb [WMFT Rate (P)]. The higher the rate the quicker they were able to complete the task. | Posted | Mean | Standard Error | Tasks per minute | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change in Wolf Motor Function Test (WMFT) Rate Non-paretic Limb | Change in Rate of the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Non-paretic limb [WMFT Rate (NP)]. The higher the rate the quicker they were able to complete the task. | Posted | Mean | Standard Error | Tasks per minute | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb Normalized to the Non-paretic Limb | Change in the normalized Rate of the Paretic limb to the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb normalized to the Non-paretic limb [WMFT Rate (P/NP)]. The higher the rate the quicker they were able to complete the task. | Posted | Mean | Standard Error | Tasks per minute | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change in Stroke Impact Scale (SIS-16) | Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stoke Impact Scale (SIS-16) for each group. Patient's perceived disability related to physical function will be indexed using the Stroke Impact Scale (SIS-16) which a subjective questionnaire asked to the subject pertaining of 16 questions. Each question is rated on scale from 1 to 5 and then the scores are totaled. Total scores can range from 16-80 (16 means that none of the functional tasks asked can be performed, a score of 80 means the subject has no issues at all performing any of the tasks asked). | Posted | Mean | Standard Error | score on a scale | Change between Baseline and Post-Test (average 6 weeks) |
|
|
|
| Secondary | Change Resting State Functional Magnetic Resonance Imaging(rsfMRI) | Functional connectivity will complement IHI measurement as a secondary outcome because while IHI records neurophysiologic interactions between a contralesional and a weak ipsilesional region, functional connectivity defines "global" interactions across multiple regions. | Not Posted | Apr 2026 | Change between Baseline and Post-Test (average 6 weeks) | Participants |
| Secondary | Change in Ipsilateral MEPs (Motor Evoked Potentials) | Output of uncrossed pathways will be studied as ipsilateral MEPs elicited in the paretic-muscle with TMS. | Not Posted | Apr 2026 | Change between Baseline and Post-Test (average 6 weeks) | Participants |
| Secondary | Diffusion Tensor Imaging (DTI) | Diffusion Tensor Imaging (DTI) enables the investigation of structural integrity and orientation of pathways in vivo through the estimation of magnitude and directionality of water diffusion. DTI metrics can help quantitate damage even when patients show no response to Transcranial Magnetic Stimulation (TMS) due to extensive damage (MEP-). Ipsilesional and contralesional corticospinal tracts will be reconstructed using probabilistic tractography. Fractional Anisotropy (FA), a unit-less measure of white matter integrity, will be calculated. | Not Posted | Apr 2026 | Baseline | Participants |
| Secondary | Change in SULCS | Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stroke Upper Limb Capacity Scale (SULCS). SULCS is a stroke-specific assessment instrument that evaluates functional capacity of the upper limb based on the execution of 10 tasks. Score ranges from 0-10 where 0 is the lowest level of function in which the participant cannot perform any of the tasks as instructed and 10 is the highest level of function in which all 10 tasks are completed as instructed. | Not Posted | Apr 2026 | Change between Baseline and Post-Test (average 6 weeks) | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | iM1 rTMS + Training | Conventional Approach Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions. | 0 | 8 | 0 | 8 | 2 | 8 |
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | neck pain after receiving TMS |
|
| scalp irritation | Nervous system disorders | Systematic Assessment | scalp irritation after receiving TMS |
|
| dizziness/lightheaded | Nervous system disorders | Systematic Assessment | dizziness/lightheaded after receiving TMS |
|
| High Blood Pressure | Cardiac disorders | Systematic Assessment | High Blood Pressure recorded during the session |
|
| Fall at home | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |