Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke
NCT ID: NCT04113525
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2019-09-24
2022-02-15
Brief Summary
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Detailed Description
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Neuromodulation techniques such as noninvasive brain, nerve and spinal direct current stimulation have been proposed as promising safe tools for augmenting motor learning and function after brain injury. Ahmed (2014) demonstrated in a pre-clinical mouse model that the use of combined trans-spinal and peripheral direct current stimulation (tsDCS + pDCS) can modulate muscle tone and potentially improve motor function. Preliminary clinical trial of safety and feasibility (Paget-blanc et al. 2019) suggests that five sessions of transcutaneous spinal direct current stimulation paired with transcutaneous peripheral direct current stimulation (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) temporarily reduce spasticity features such as catch response to slow and fast joint stretch and overall stiffness of the affected extremity with optimal reductions in spasticity occurring 2-3 weeks post stimulation intervention. Unexpectedly, participants also experienced significant improvements in motor function, suggestive that tsDCS+ pDCS may provide a therapeutic window to further augment motor outcomes with robotic wrist training.
The investigators propose a study to evaluate whether two doses of five consecutive days of paired spinal and peripheral noninvasive stimulation combined with six weeks of intensive (three times a week) robotic therapy will significantly alter the clinical and objective measures of spasticity and motor function of the wrist in participants with upper extremity spasticity after stroke.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Stimulation + Robotic Wrist Therapy
Two courses of five consecutive days of 20 minute trans-spinal and trans-peripheral nerve active stimulation (total of 10 sessions) combined with a six-week intensive wrist robotic training program.
MyoRegulator™ System
Paired transcutaneous spinal and peripheral nerve stimulation
Sham Stimulation + Robotic Wrist Therapy
Two courses of five consecutive days of 20 minute trans-spinal and trans-peripheral nerve sham stimulation (total of 10 sessions) combined with a six-week intensive wrist robotic training program.
MyoRegulator™ System
Paired transcutaneous spinal and peripheral nerve stimulation
Interventions
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MyoRegulator™ System
Paired transcutaneous spinal and peripheral nerve stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First and only single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
* Cognitive function sufficient to understand the experiments and follow instructions (per interview with PI or study investigators)
* Fugl-Meyer assessment (minimum score of 12 out of 66 - not completely plegic in the muscles of affected wrist)
* A Modified Ashworth score between 1-3 points for wrist flexors and extensors
* A minimum of 15 degrees wrist passive ROM for wrist flexion and extension from wrist neutral position
* Body fat range of 15-25mm for females/10-20mm for males of adipose tissue at the cervical neck level and a body fat range of 10-40mm for females/5-35mm for males of adipose tissue at the suprailiac crest, as determined by a body fat caliper
Exclusion Criteria
* Fixed contracture or complete flaccid paralysis of the affected wrist
* Introduction of any new rehabilitation interventions during study
* Pregnant or plan on becoming pregnant or breastfeeding during the study period as determined by self-report
* Focal brainstem or thalamic infarcts
* Prior surgical treatments for spasticity of the upper limb
* Ongoing use of CNS-active medications for spasticity (enrollment to be determined by PI review)
* History of spinal cord injury or weakness
* Chronic pain, defined by a report of a "5" or greater on the Wong-Baker Pain Scale
* Peripheral neuropathy including insulin dependent diabetes as determined by case history
* Presence of additional potential tsDCS risk factors:
* Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
* Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
* Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation); this will be reviewed on a case by case basis for PI to make a determination
* Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Bruce Volpe
Principal Investigator
Principal Investigators
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Bruce T Volpe, MD
Role: PRINCIPAL_INVESTIGATOR
The Feinstein Institutes For Medical Research - Northwell Health
Locations
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The Feinstein Institutes For Medical Research - Northwell Health
Manhasset, New York, United States
Countries
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References
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Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
Volpe BT, Huerta PT, Zipse JL, Rykman A, Edwards D, Dipietro L, Hogan N, Krebs HI. Robotic devices as therapeutic and diagnostic tools for stroke recovery. Arch Neurol. 2009 Sep;66(9):1086-90. doi: 10.1001/archneurol.2009.182.
Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
Ahmed Z. Trans-spinal direct current stimulation modulates motor cortex-induced muscle contraction in mice. J Appl Physiol (1985). 2011 May;110(5):1414-24. doi: 10.1152/japplphysiol.01390.2010. Epub 2011 Feb 24.
Ahmed Z. Trans-spinal direct current stimulation alters muscle tone in mice with and without spinal cord injury with spasticity. J Neurosci. 2014 Jan 29;34(5):1701-9. doi: 10.1523/JNEUROSCI.4445-13.2014.
Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.
Bocci T, Vannini B, Torzini A, Mazzatenta A, Vergari M, Cogiamanian F, Priori A, Sartucci F. Cathodal transcutaneous spinal direct current stimulation (tsDCS) improves motor unit recruitment in healthy subjects. Neurosci Lett. 2014 Aug 22;578:75-9. doi: 10.1016/j.neulet.2014.06.037. Epub 2014 Jun 23.
Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.
Related Links
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Other Identifiers
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19-0063
Identifier Type: -
Identifier Source: org_study_id
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