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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Feinstein Institute for Medical Research | OTHER |
| Massachusetts Institute of Technology | OTHER |
| Spaulding Rehabilitation Hospital |
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Motor skill training and transcranial direct current stimulation (tDCS) have separately been shown to alter cortical excitability and enhance motor function in humans. Their combination is appealing for augmenting motor recovery in stroke patients, and this is an area presently under heavy investigation globally. The investigators have previously shown that the timing of tDCS application has functional significance, that tDCS applied prior to training can be beneficial for voluntary behavior, and that tDCS effects may not simply be additive to training effects, but may change the nature of the training effect. The investigators have separately reported in a randomized-controlled clinical trial, that upper limb robotic training alone over 12 weeks can improve clinical function of chronic stroke patients. Based on our results with tDCS and robotic training, the investigators hypothesize that the same repeated sessions of robotic training, but preceded by tDCS, would lead to a sustained and functional change greater than robotic training alone. The investigators will determine if clinical function can be improved and sustained with tDCS-robotic training and cortical physiology changes that underlie functional improvements.
The primary aim of this study is to evaluate whether multiple sessions of combined tDCS and robotic upper limb training in chronic hemiplegia, leads to clinical improvement in upperlimb motor impairment. In chronic stroke patients (>6months post-injury, stable unilateral motor deficit) using a within-subjects repeated-measures design we will evaluate the effects of 12 weeks of robotic upperlimb training (3x/week, 36 sessions, shoulder/elbow/wrist in each session) with real or sham tDCS before the robotic training. Clinical improvement will be determined by a change in upper-limb Fugl-Meyer (primary), the Medical Research Council motor power score (MRC), Wolf Motor Function Test, Barthel Index, and Stroke Impact Scale (secondary) outcome measures following the training, and assessed again six months later.
The investigators further aim to identify and compare the neurophysiological characteristics between intervention groups. The relationship between clinical improvement and neurophysiological measures pertaining to robotic motor training following stroke are presently not described in the literature. By measuring the EMG response from forearm musculature to Transcranial Magnetic Stimulation the investigators will establish: (i) plasticity associated with training, and (ii) the neurophysiological characteristics of patients who respond to training. By understanding how brain excitability changes underpin motor dysfunction, and motor recovery, interventions can be more effectively prescribed and prognoses established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. |
|
| Sham tDCS | Sham Comparator | Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Upper Limb Fugl Meyer Score | Upper limb fugl Meyer score is a measure of upper extremity motor weakness on a 66-point scale. Fugl Meyer score range: 0-66. Higher scores indicate better outcome. Units: Units on a scale. | Baseline and after the 12-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dylan Edwards, PhD | Moss Rehabilitation Institute | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16307247 | Background | Heide G, Witte OW, Ziemann U. Physiology of modulation of motor cortex excitability by low-frequency suprathreshold repetitive transcranial magnetic stimulation. Exp Brain Res. 2006 May;171(1):26-34. doi: 10.1007/s00221-005-0262-0. Epub 2005 Nov 24. | |
| 16890483 | Background | Fitzgerald PB, Fountain S, Daskalakis ZJ. A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition. Clin Neurophysiol. 2006 Dec;117(12):2584-96. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4. |
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There is no plan to make individual participant data available to other researchers at this time.
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CVA's identified (n=1600)
Excluded on initial screen (n=859)
425 with residential proximity to studying site contacted
Excluded for the following reasons (n=343)
Randomized (n=82)
Robot Sham (n=41)
Robot tDCS (n=41)
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
| FG001 | Sham tDCS | Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Between January 2012 and January 2016, 82 participants with chronic stroke were enrolled in the study across the two sites (65 Site 1, 17 Site 2), and were randomized to Robot-tDCS (n = 41) or Robot-Sham (n = 41) groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 From Baseline in Upper Limb Fugl Meyer Score | Upper limb fugl Meyer score is a measure of upper extremity motor weakness on a 66-point scale. Fugl Meyer score range: 0-66. Higher scores indicate better outcome. Units: Units on a scale. | Of the 41 enrolled for active tDCS, 1 was lost due to unrelated illness and could not complete assessment after the 12-week intervention. Only 40 participant's data were included in the analysis. Of the 41 enrolled for Sham tDCS, 1 person was excluded due to Botox treatment, 2 people were excluded due to unrelated illness and 1 other person was excluded due to related illness. Only 37 participant's data were included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and after the 12-week intervention |
|
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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 | Active tDCS | Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin adverse event | Skin and subcutaneous tissue disorders | Systematic Assessment | Scalp burning sensation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dylan Edwards | Moss Rehabilitation Research Institute | (215) 663-6411 | EdwardDy@einstein.edu |
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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 |
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| OTHER |
We conducted a double-blind, sham-controlled, repeated-measures study design evaluating the effects of 12 weeks of robot-assisted upper-limb training (3x/week, 36 sessions) with tDCS (Robot-tDCS) or sham tDCS (Robot-Sham ) delivered at rest before each robot-assisted training session.
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Staff delivering the transcranial direct current stimulation and performing evaluations are blinded to active vs. sham stimulation.
| Upper extremity robotics | Device | Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
|
| 16148743 | Background | Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e. |
| 15634731 | Background | Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5. |
| 15753425 | Background | Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9. |
| 2249872 | Background | McCreery DB, Agnew WF, Yuen TG, Bullara L. Charge density and charge per phase as cofactors in neural injury induced by electrical stimulation. IEEE Trans Biomed Eng. 1990 Oct;37(10):996-1001. doi: 10.1109/10.102812. |
| 14580622 | Background | Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available. |
| 15351385 | Background | Nitsche MA, Niehaus L, Hoffmann KT, Hengst S, Liebetanz D, Paulus W, Meyer BU. MRI study of human brain exposed to weak direct current stimulation of the frontal cortex. Clin Neurophysiol. 2004 Oct;115(10):2419-23. doi: 10.1016/j.clinph.2004.05.001. |
| 7922470 | Background | Pascual-Leone A, Valls-Sole J, Wassermann EM, Hallett M. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain. 1994 Aug;117 ( Pt 4):847-58. doi: 10.1093/brain/117.4.847. |
| 12686266 | Background | Priori A. Brain polarization in humans: a reappraisal of an old tool for prolonged non-invasive modulation of brain excitability. Clin Neurophysiol. 2003 Apr;114(4):589-95. doi: 10.1016/s1388-2457(02)00437-6. |
| 17102691 | Background | Talelli P, Rothwell J. Does brain stimulation after stroke have a future? Curr Opin Neurol. 2006 Dec;19(6):543-50. doi: 10.1097/WCO.0b013e32801080d1. |
| 12738425 | Background | Tassinari CA, Cincotta M, Zaccara G, Michelucci R. Transcranial magnetic stimulation and epilepsy. Clin Neurophysiol. 2003 May;114(5):777-98. doi: 10.1016/s1388-2457(03)00004-x. |
| 12760210 | Background | Volpe BT, Krebs HI, Hogan N. Robot-aided sensorimotor training in stroke rehabilitation. Adv Neurol. 2003;92:429-33. |
| 10563646 | Background | Volpe BT, Krebs HI, Hogan N, Edelsteinn L, Diels CM, Aisen ML. Robot training enhanced motor outcome in patients with stroke maintained over 3 years. Neurology. 1999 Nov 10;53(8):1874-6. doi: 10.1212/wnl.53.8.1874. |
| 15596603 | Background | Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844. |
| 9474057 | Background | Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8. |
| 17012061 | Background | Webster BR, Celnik PA, Cohen LG. Noninvasive brain stimulation in stroke rehabilitation. NeuroRx. 2006 Oct;3(4):474-81. doi: 10.1016/j.nurx.2006.07.008. |
| 7301072 | Background | Yuen TG, Agnew WF, Bullara LA, Jacques S, McCreery DB. Histological evaluation of neural damage from electrical stimulation: considerations for the selection of parameters for clinical application. Neurosurgery. 1981 Sep;9(3):292-9. |
| 34963502 | Derived | Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8. |
| 34963501 | Derived | Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9. |
| BG001 | Sham tDCS | Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Time since stroke | Median | Inter-Quartile Range | days |
|
| Fugl-Meyer score | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Sham tDCS | Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. |
|
|
| 0 |
| 41 |
| 12 |
| 41 |
| EG001 | Sham tDCS | Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study. | 0 | 41 | 4 | 41 |
|
| Headache | Nervous system disorders | Systematic Assessment | Headache |
|
| Skin adverse event | Skin and subcutaneous tissue disorders | Systematic Assessment | Tingling |
|
| Skin adverse event | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin redness |
|
| Sleepiness | Nervous system disorders | Systematic Assessment | Sleepiness |
|
| Trouble concentrating | Nervous system disorders | Systematic Assessment | Trouble concentrating |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |