Transcutaneous Electrical Stimulation for Stroke Patients

Official title

Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

Overview

This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.

Detailed description

Upper limb (UL) hemiparesis is the most common post-stroke disability. Currently, there is no treatment used in the clinic that has shown to be efficacious for 75% of individuals who have moderate to severe UL hemiparesis. There are no interventions for individuals with moderate to severe hemiparesis that have demonstrated superiority in comparison to standard care. These stroke patients often have increased spasticity and muscle weakness, resulting in chronic upper limb dysfunction. We are proposing an alternative strategy to improve upper limb function after stroke: transcutaneous electrical stimulation of the spinal cord (TESS). Our objective is to evaluate the feasibility and neural effects of transcutaneous spinal stimulation plus task specific training in a two-arm study with three time points (pre-/post-intervention and follow-up). We will recruit 14 chronic post-stroke participants who will receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training. Our long-term research goal is to use TESS as a therapeutic strategy, combined with task specific training, to improve upper limb impairment and function in chronic stroke survivors. Our central hypothesis is that excitation of spinal circuitry by spinal stimulation will result in more effective motor control that will improve volitional upper limb movement (as compared to sham stimulation plus task specific training). This hypothesis is based on published work in cervical spinal cord injury.

Interventions

• Other Task Specific Training (TST)
  Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.
• Other Transcutaneous electrical spinal cord stimulation (TESS)
  The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks.
• Other Sham transcutaneous electrical spinal cord stimulation (Sham TESS)
  The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding.

Primary outcome measures

• Fugl-Meyer Test of Upper Extremity Function (FMUE) [Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation]
• Modified Ashworth Scale (MAS) [Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation]
• Grip Strength [Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation]
• Chedoke Arm & Hand Activity Index (CAHAI-9) [Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation]
• Canadian Occupational Performance Measure (COPM) [Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation]

Secondary outcome measures (3)

• Motor evoked potential status (MEPs) [Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation]
• Maximum Voluntary Contraction (MVC) [Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation]
• H-reflex [Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation]

Eligibility criteria

Inclusion criteria

• 18 years or older
• able and willing to give written consent and comply with study procedures
• at least 6 months post-stroke
• hemiplegia secondary to stroke
• UE Fugle Meyer Assessment <35
• not currently receiving regular occupational therapy services
• participant has received clearance from physician to participate in study
• participant has at least a rudimentary comprehension of English

Exclusion criteria

• botox injection in upper extremity within the last 4 months
• modified ashworth score of 4 in any joint of the affected limb
• pregnant or nursing
• using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants
• unhealed bone fractures
• severe contractures in the upper extremities
• active cancer or cancer remission less than 5 years
• orthopedic dysfunction, injury, or surgery that would impact the individual's ability to use the upper extremities
• recent procedure or operation of the spinal cord within the past year
• traumatic brain injury or neurological conditions that would impact the study
• skull fracture that has developed within the past 6 months
• non-English speakers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Shirley Ryan AbilityLab — Chicago

Publications

• Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095. PMID 17077374
• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. PMID 1135616
• Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, Dunkley M, Miller P, Masters L. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004 Fall;11(4):31-42. doi: 10.1310/JU8P-UVK6-68VW-CF3W. PMID 15592988
• Benavides FD, Jo HJ, Lundell H, Edgerton VR, Gerasimenko Y, Perez MA. Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. J Neurosci. 2020 Mar 25;40(13):2633-2643. doi: 10.1523/JNEUROSCI.2374-19.2020. Epub 2020 Jan 29. PMID 31996455
• Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943. PMID 31609714

Identifiers

NCT: NCT06950593 · STU00220717

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗