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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS102353 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS + mCIMT | Sham Comparator | Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT) |
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| 2 mA tDCS + mCIMT | Active Comparator | 2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT) |
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| 4 mA + mCIMT | Active Comparator | 4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham | Device | Sham group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in FM-UE From Baseline | The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in WMFT Time Score From Baseline | The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better. |
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Each subject must meet all of the following criteria to participate in this study:
Each Subject who meets any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Feng, MD | Duke University | Principal Investigator |
| Gottfried Schlaug, MD, PhD | Baystate Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35249 | United States | ||
| Keck Hospital of USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40157380 | Derived | Schlaug G, Cassarly C, Feld JA, Wolf SL, Rowe VT, Fritz S, Chhatbar PY, Shinde A, Su Z, Broderick JP, Zorowitz R, Awosika O, Edwards D, Lin C, Franciso GE, Wittenberg GF, Pundik S, Gregory C, Borich MR, Ramakrishnan V, Feng W. Safety and efficacy of transcranial direct current stimulation in addition to constraint-induced movement therapy for post-stroke motor recovery (TRANSPORT2): a phase 2, multicentre, randomised, sham-controlled triple-blind trial. Lancet Neurol. 2025 May;24(5):400-412. doi: 10.1016/S1474-4422(25)00044-4. Epub 2025 Mar 26. |
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We will follow the National Institute of Health Stroke Trial Network policy and procedure to share IPD. Please refer to https://nihstrokenet.org/ for detailed information.
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Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham tDCS + mCIMT | Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 |
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| Low dose tDCS | Device | The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session |
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| High dose tDCS | Device | The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session |
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| mCIMT | Behavioral | All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session |
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| Day 15 |
| Mean Change in SIS Hand Subscale From Baseline | The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best). | Day 15 |
| Los Angeles |
| California |
| 90089 |
| United States |
| MedStar National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Emory Rehabilitation Hospital | Atlanta | Georgia | 30322 | United States |
| Cardinal Hill Rehabilitation Hospital | Lexington | Kentucky | 40504 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Burke Rehabilitation Center | White Plains | New York | 10605 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Cleveland VA Medical Center | Cleveland | Ohio | 44106 | United States |
| Moss Rehabilitation Research Institute | Elkins Park | Pennsylvania | 19027 | United States |
| University of Pittsburgh Medical Center Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina University Hospital | Charleston | South Carolina | 29425 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| 2 mA tDCS + mCIMT |
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
| FG002 | 4 mA + mCIMT | 4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham tDCS + mCIMT | Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
| BG001 | 2 mA tDCS + mCIMT | 2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
| BG002 | 4 mA + mCIMT | 4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. |
| BG003 | 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 | Median | Inter-Quartile Range | years |
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| 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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| Time from Index Stroke to Randomization | Count of Participants | Participants |
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| Pre-Stroke Dominant Side | Count of Participants | Participants |
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| Side of the Body Made Weak by the Index Stroke | Count of Participants | Participants |
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| Pre-Stroke Modified Rankin Scale (mRS) | The MRS has a score range of 0 to 6, where a higher score indicates poorer function. | Count of Participants | Participants |
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| Fugl-Meyer Upper-Extremity (FM-UE) Scale | The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. | Median | Inter-Quartile Range | units on a scale |
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| Montreal Cognitive Assessment (MoCA) | The MoCA has a score range of 0 to 30, where a higher score indicates better cognitive function. | Median | Inter-Quartile Range | units on a scale |
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| NIH Stroke Scale (NIHSS) | The NIHSS has a score range of 0 to 42, where a higher score indicates greater stroke severity. | Median | Inter-Quartile Range | units on a scale |
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| Wolf-Motor Functional Test (WMFT) Time Score | The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better. | Median | Inter-Quartile Range | seconds |
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| Log(WMFT Time Score) | Logarithmic transformation of WMFT Time Score | Median | Inter-Quartile Range | log(seconds) |
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| Stroke Impact Scale (SIS) Hand Subscale | The SIS has a score range of 0 to 100, where a higher score indicates better quality of life after a stroke. | Median | Inter-Quartile Range | units on a scale |
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| Lesion Volume - Affected Side (Centrally Assessed) | Missing for one participant randomized to Sham tDCS + mCIMT | Median | Inter-Quartile Range | centimeters cubed |
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| Weighted Corticospinal Tract (wCST) Lesion Load - Affected Side (Centrally Assessed) | Missing for one subject randomized to Sham tDCS + mCIMT | Median | Inter-Quartile Range | centimeters cubed |
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| Presumed Motor Evoked Potential (MEP) Positive - Affected Side | MEP was presumed positive if the %MSO<100 for the more affected side rMT by local TMS rater | Missing for one subject randomized to Sham tDCS + mCIMT. | Count of Participants | Participants |
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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 | Mean Change in FM-UE From Baseline | The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted. | Modified intent to treat population which included all subjects with any post-baseline data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 15 |
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| Secondary | Mean Change in WMFT Time Score From Baseline | The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better. | Posted | Mean | 95% Confidence Interval | score on a scale | Day 15 |
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| Secondary | Mean Change in SIS Hand Subscale From Baseline | The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best). | Posted | Mean | 95% Confidence Interval | score on a scale | Day 15 |
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Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
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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) |
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| EG000 | Sham tDCS + mCIMT | Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. | 0 | 43 | 2 | 43 | 4 | 43 |
| EG001 | 2 mA tDCS + mCIMT | 2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. | 0 | 43 | 0 | 43 | 1 | 43 |
| EG002 | 4 mA + mCIMT | 4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session. | 0 | 43 | 5 | 43 | 5 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA (23) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (23) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (23) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23) | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA (23) | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (23) | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (23) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Fatigue | General disorders | MedDRA (23) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (23) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wayne Feng, MD | Duke University | 919-681-1700 | wayne.feng@duke.edu |
| Jun 16, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 3, 2023 | Jul 12, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009043 | Motor Activity |
| 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 |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
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