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A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBS-rTMS + task-oriented rehabilitation | Active Comparator | NBS-guided rTMS + task-oriented rehabilitation |
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| Sham rTMS + task-oriented rehabilitation | Sham Comparator | Sham rTMS + task-oriented rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBS-guided rTMS | Device |
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| |
| Sham rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Fugl-Meyer Score | Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID). | Baseline - 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Arm-Research Action Test (ARAT) | Scale minimum 0, maximum 57. Greater values indicate better motor function. | Baseline - 6 months post-treatment |
| Wolf Motor Function Test | Time in seconds to perform test tasks. Shorter time indicates better motor function. |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups | Serious Adverse Events were recorded and their occurrence was compared between treatment arms | Baseline - 6 months post-treatment |
Inclusion Criteria :
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Harvey, MD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Rancho Los Amigos National Rehabilitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30354990 | Result | Harvey RL, Edwards D, Dunning K, Fregni F, Stein J, Laine J, Rogers LM, Vox F, Durand-Sanchez A, Bockbrader M, Goldstein LB, Francisco GE, Kinney CL, Liu CY; NICHE Trial Investigators *. Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke. Stroke. 2018 Sep;49(9):2138-2146. doi: 10.1161/STROKEAHA.117.020607. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NBS-rTMS + Task-oriented Rehabilitation | NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation |
| FG001 | Sham rTMS + Task-oriented Rehabilitation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
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| Task oriented rehabilitation | Procedure |
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| Baseline - 6 months post-treatment |
| NIH Stroke Scale (NIHSS) | Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42) | Baseline - 6 months post-treatment |
| Chedoke-McMaster Stroke Assessment (CMSA) | Scale minimum 1, maximum 7. Higher values indicate better motor function of hand. | Baseline - 6 months post-treatment |
| Stroke Impact Scale (SIS) | Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function | Baseline - 6 months post-treatment |
| Patient Health Questionnaire (PHQ9) | The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood | Baseline - 6 months post-treatment |
| Quality of Life Assessment: EuroQol EQ-5D Scale | The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life. | Baseline - 6 months post-treatment |
| Downey |
| California |
| 90242 |
| United States |
| Shepherd Rehabilitation Center | Atlanta | Georgia | 30309 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Indiana University Indianapolis | Indianapolis | Indiana | 46202 | United States |
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
| Columbia Cornell New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Burke Medical Research Institute, Weill Cornell Neurology | White Plains | New York | 10605 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| TIRR Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NBS-rTMS + Task-oriented Rehabilitation | NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation |
| BG001 | Sham rTMS + Task-oriented Rehabilitation | Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Upper Extremity Fugl-Meyer | Scale minimum 0, maximum 66. Higher values indicate better motor function. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Arm Research Action Test | Scale minimum 0, maximum 57. Greater values indicate better motor function | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Wolf Motor Function Test | Time in seconds to perform test tasks. Shorter time indicates better motor function. | Mean | Standard Deviation | seconds of time |
| ||||||||||||||
| Chedoke-McMaster Stroke Assessment Hand | Scale minimum 1, maximum 7. HIgher score indicates better function. | Mean | Standard Deviation | units on a scale |
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| Chedoke-McMaster Stroke Assessment Arn | Scale minimum 1, maximum 7. Higher values indicate better motor function. | Mean | Standard Deviation | units on a scale |
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| NIH Stroke Scale | Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Stroke Impact Scale | Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Patient Health Questionnaire - 9 (PHQ9) | The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| EuroQol ED-5Q scale | The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life. | Mean | Standard Deviation | units on a scale |
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| 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 | Upper Extremity Fugl-Meyer Score | Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID). | Intent to treat | Posted | Count of Participants | Participants | Baseline - 6 months post-treatment |
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| Secondary | Arm-Research Action Test (ARAT) | Scale minimum 0, maximum 57. Greater values indicate better motor function. | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Secondary | Wolf Motor Function Test | Time in seconds to perform test tasks. Shorter time indicates better motor function. | Intent to treat | Posted | Mean | Standard Deviation | seconds of time | Baseline - 6 months post-treatment |
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| Secondary | NIH Stroke Scale (NIHSS) | Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42) | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Secondary | Chedoke-McMaster Stroke Assessment (CMSA) | Scale minimum 1, maximum 7. Higher values indicate better motor function of hand. | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Secondary | Stroke Impact Scale (SIS) | Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Secondary | Patient Health Questionnaire (PHQ9) | The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Secondary | Quality of Life Assessment: EuroQol EQ-5D Scale | The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life. | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months post-treatment |
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| Other Pre-specified | To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups | Serious Adverse Events were recorded and their occurrence was compared between treatment arms | Intent to treat | Posted | Number | number of events | Baseline - 6 months post-treatment |
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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 | NBS-rTMS + Task-oriented Rehabilitation | NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation | 1 | 132 | 11 | 132 | 30 | 132 |
| EG001 | Sham rTMS + Task-oriented Rehabilitation | Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation | 0 | 67 | 7 | 67 | 15 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Carotid artery disease | Nervous system disorders | Systematic Assessment |
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| Convulsion | Nervous system disorders | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | Systematic Assessment |
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| VIIth nerve paralysis | Nervous system disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Device related infection | Infections and infestations | Systematic Assessment | Not study device involvement |
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| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Coronary artery bypass | Surgical and medical procedures | Systematic Assessment |
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| Hip surgery | Surgical and medical procedures | Systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombosis in device | General disorders | Systematic Assessment | Not study device |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Spasms in hand | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasticity | Nervous system disorders | Systematic Assessment |
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| Increased lacrimation | Eye disorders | Systematic Assessment |
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| Blepharospasm | Eye disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Panic attack | Psychiatric disorders | Systematic Assessment |
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| Hallucination olfactory | Psychiatric disorders | Systematic Assessment |
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| Hallucination auditory | Psychiatric disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Nexstim Plc | jarmo.laine@nexstim.com |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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