Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke

NCT04113525 | Terminated

• 1 other identifier: 19-0063
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spasticity as Sequela of Stroke; Stroke; Stroke Sequelae; Hemiplegia, Spastic; Hemiparesis; Upper Limb Hypertonia; CVA

Keywords

Stroke Rehabilitation; Neuromodulation; Transcutaneous Spinal Direct Current Stimulation; Robotic Therapy; Transcutaneous Peripheral Direct Current Stimulation; Spasticity; Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in upper extremity Fugl-Meyer assessment

  Change from baseline (Admission) at discharge (D-A) and at Four week Follow-up (FU-A)

Study Arms (2)

Active Stimulation + Robotic Wrist Therapy

EXPERIMENTAL

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.

Device: MyoRegulator™ System

Sham Stimulation + Robotic Wrist Therapy

SHAM COMPARATOR

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.

Device: MyoRegulator™ System

Interventions

MyoRegulator™ System DEVICE

Paired transcutaneous spinal and peripheral nerve stimulation

Also known as: Doublestim™

Active Stimulation + Robotic Wrist Therapy; Sham Stimulation + Robotic Wrist Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

The Feinstein Institutes For Medical Research - Northwell Health

Manhasset, New York, 11030, United States

Location

Related Publications (9)

• Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.

  PMID: 15843670 BACKGROUND

• 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.

  PMID: 27145936 BACKGROUND

• 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.

  PMID: 19752297 BACKGROUND

• 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.

  PMID: 20400552 BACKGROUND

• 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.

  PMID: 21350028 BACKGROUND

• 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.

  PMID: 24478352 BACKGROUND

• 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.

  PMID: 8650578 BACKGROUND

• 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.

  PMID: 24970753 BACKGROUND

• 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.

  PMID: 7192811 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Bruce T Volpe, MD

  The Feinstein Institutes For Medical Research - Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 2, 2019
• Study Start: September 24, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: April 14, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)