Transcutaneous Electrical Stimulation for Stroke Patients

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Upper Limb Hemiparesis Following Stroke

Treatments: Other: Sham transcutaneous electrical spinal cord stimulation (Sham TESS); Other: Transcutaneous electrical spinal cord stimulation (TESS); Other: Task Specific Training (TST)

Study type: Interventional

Funder types: Other

Identifiers

NCT06950593

STU00220717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Experimental Group

Active Comparator group

Description:

This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session.

Treatment:

Other: Task Specific Training (TST)

Other: Transcutaneous electrical spinal cord stimulation (TESS)

Comparator Group

Active Comparator group

Description:

This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session.

Treatment:

Other: Task Specific Training (TST)

Other: Sham transcutaneous electrical spinal cord stimulation (Sham TESS)