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

Primary Purpose

Spasticity as Sequela of Stroke, Stroke, Stroke Sequelae

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MyoRegulator™ System

About this trial

This is an interventional treatment trial for Spasticity as Sequela of Stroke focused on measuring Stroke Rehabilitation, Neuromodulation, Transcutaneous Spinal Direct Current Stimulation, Robotic Therapy, Transcutaneous Peripheral Direct Current Stimulation, Spasticity, Hemiparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Feinstein Institutes For Medical Research - Northwell Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Stimulation + Robotic Wrist Therapy

Sham Stimulation + Robotic Wrist Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04113525

First Posted

September 25, 2019

Last Updated

April 7, 2022

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT04113525

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

company went bankrupt, covid closed clinical research facility

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

February 15, 2022 (Actual)

Study Completion Date

February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Stroke is the fifth leading cause of death and the leading cause of serious long-term disability in the U.S. Post-stroke impairment often presents as weakness of the upper and lower limbs and spasticity (muscle and joint stiffness and hyperactivity). This condition impacts motor recovery and renders the individual dependent for most activities of daily living. Even with aggressive standard rehabilitation, 65 percent of patients cannot incorporate their affected hand in functional activities six months after stroke. Investigators have previously demonstrated that robotic therapy provides significant benefits to upper limb motor recovery after stroke. The treatment has been acknowledged by the American Heart Association as an effective form of stroke rehabilitation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation + Robotic Wrist Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham Stimulation + Robotic Wrist Therapy

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

MyoRegulator™ System

Other Intervention Name(s)

Doublestim™

Intervention Description

Paired transcutaneous spinal and peripheral nerve stimulation

Primary Outcome Measure Information:

Title

Instrumental assessment of change in wrist muscle tone

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes in upper extremity Fugl-Meyer assessment

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce T Volpe, MD

Organizational Affiliation

The Feinstein Institutes For Medical Research - Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Feinstein Institutes For Medical Research - Northwell Health

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plans.

Citations:

PubMed Identifier

15843670

Citation

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

Results Reference

background

PubMed Identifier

27145936

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. Erratum In: Stroke. 2017 Feb;48(2):e78. Stroke. 2017 Dec;48(12 ):e369.

Results Reference

background

PubMed Identifier

19752297

Citation

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.

Results Reference

background

PubMed Identifier

20400552

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.

Results Reference

background

PubMed Identifier

21350028

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.

Results Reference

background

PubMed Identifier

24478352

Citation

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.

Results Reference

background

PubMed Identifier

8650578

Citation

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.

Results Reference

background

PubMed Identifier

24970753

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.

Results Reference

background

PubMed Identifier

7192811

Citation

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.

Results Reference

result

Links:

URL

https://bioelecmed.biomedcentral.com/articles/10.1186/s42234-019-0028-9

Description

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

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