Transcutaneous Spinal Stimulation and Exercise for Locomotion

Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion

Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date.

This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with intensive physical therapy for improving locomotion in people with incomplete tetraplegia and paraplegia.

This experiment design consists of two to four-phase intervention programs, including one-month physical therapy only followed by one-month spinal stimulation combined with physical therapy. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions. The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of interventions. Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal stimulation and intensive physical therapy will be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Transcutaneous spinal stimulation; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soshi Samejima, DPT, MS; Phone Number: 206 221-8961; Email: soshis@uw.edu
• Study Contact Backup: Name: Chet Moritz, PhD; Phone Number: 206 221-2842; Email: ctmoritz@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Soshi Samejima; Email: soshis@uw.edu
      • Contact: Chet Moritz; Email: ctmoritz@uw.edu
      • Principal Investigator: Chet Moritz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has spinal cord injury (T12 or higher level) of at least 1-year duration
• Is between 21 and 70 years of age
• Has difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing)
• Has stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities
• Is capable of performing simple cued motor tasks
• Has ability to attend up to 5 sessions per week physical therapy sessions and testing activities
• Has adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
• Is volunteering to be involved in this study
• Cleared for gait training by the primary physician of the subject
• Has the ability to read and speak English

Exclusion Criteria:

• Has autoimmune etiology of spinal cord dysfunction/injury
• Has history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
• Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• Has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• Has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
• Has active cancer
• Has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
• Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities
• Has any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
• is pregnant
• is dependent on ventilation support
• Has implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc).
• Has depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score >16/60) and General Anxiety Disorder-7 item Questionnaire (score >9/21), respectively.
• Has alcohol and/or drug abuse.
• Has cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score >2/10).
• is unable to read and/or comprehend the consent form.
• is unable to understand the instructions given as part of the study
• Has established osteoporosis and taking medication for osteoporosis treatment.
• Has bone mineral density T scores ≤ -3.5 in the anteroposterior lumbar spine and/or proximal femur measured by DEXA (if participants are clear for other criteria and have not been examined by Dual Energy Xray Absorptiometry (DEXA) at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity)
• Has low-energy fracture history before or after spinal cord injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcutaneous spinal stimulation & Physical therapy; Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions	Device: Transcutaneous spinal stimulation; Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions; Other Names: Physical Therapy; Other: Physical Therapy; physical therapy to improve walking and standing functions
Active Comparator: Physical therapy only; Physical therapy that targets rehabilitation of walking and standing functions	Other: Physical Therapy; physical therapy to improve walking and standing functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walk Test	Measurement of walking ability. The distance is reported in meter.	8-11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination	Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.	8-11 months
Somatosensory evoked potentials	Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts.	8-11 months
Berg Balance Test	Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4).	8-11 months
Ten-minute walk test	Measurement of walking ability. The walking speed is reported in meter per second.	8-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire	Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population.	8-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire	Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population.	8-11 months
Somatosensory evoked potentials	Measurement of latency of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The latency of the response is reported in micro-seconds.	8-11 months
Motor evoked potentials	Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds.	8-11 months
Motor evoked potentials	Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts.	8-11 months
Kinetic and kinematic gait analysis using 3D camera system	Measurement of leg function and walking ability. Joint angle is reported in degree angle.	8-11 months
Kinetic and kinematic gait analysis using 3D camera system	Measurement of leg function and walking ability. Velocity is reported in meter per second.	8-11 months
Electromyography recording of lower extremity and trunk muscles	Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.	8-11 months
Modified Ashworth Scale	Measurement of spasticity. Tests resistance to passive movement about joints. Score range from 0-4, with 6 choices.	8-11 months
Neurogenic Bowel Dysfunction Score	self-report questionnaire designed to help healthcare professionals evaluate the effectiveness of their patient's current bowel management routine by assessing the impact it has on the patient's quality of life. Questions ask about background parameters (n=8), faecal incontinence (n=10), constipation (n=10), obstructed defecation (n=8), and impact on quality of life (QOL).	8-11 months
Neurogenic Bladder Symptom Score	objective and validated self-report questionnaire to assess bladder symptoms in patients with neurogenic bladder dysfunction.	8-11 months

Collaborators and Investigators

• Sponsor: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Spinal electrical stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: STUDY00003070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No