Stroke Clinical Trial
Official title:
The Effect of Treatment With the Doublestim™ Neuromodulation System Incorporating Transcutaneous Spinal Direct Current Stimulation Paired With Robotic Therapy in Patients With Wrist Spasticity After Stroke
Verified date | September 2021 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.
Status | Terminated |
Enrollment | 13 |
Est. completion date | February 15, 2022 |
Est. primary completion date | February 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 18 years of age - 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: - Botox or phenol alcohol treatment of the upper extremity within 3 months of stimulation intervention - 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Feinstein Institutes For Medical Research - Northwell Health | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. Review. — View Citation
Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. — View Citation
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. Erratum in: N Engl J Med. 2011 Nov 3;365(18):1749. — View Citation
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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. Review. — View Citation
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. Review. Erratum in: Stroke. 2017 Feb;48(2):e78. Stroke. 2017 Dec;48(12 ):e369. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Instrumental assessment of change in wrist muscle tone | As primary outcome measure, the team will investigate whether Doublestim™ intervention paired with robotic therapy significantly changes the catch response during wrist extension as recorded by a biomechanical force transducer. | Change from baseline (Admission) at discharge (D-A) and at Four week Follow-up (FU-A) | |
Secondary | Changes in upper extremity Fugl-Meyer assessment | As secondary outcome measure, the team will test whether active Doublestim™ stimulation (10 sessions) paired with intensive robotic intervention (18 sessions) significantly improves wrist motor function as compared to sham stimulation paired with intensity-matched robotics. | Change from baseline (Admission) at discharge (D-A) and at Four week Follow-up (FU-A) |
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