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Transcutaneous Spinal Stimulation and Exercise for Locomotion

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ClinicalTrials.gov Identifier: NCT03509558
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Chet Moritz, University of Washington

Brief Summary:

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 for 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, is also revealing significant improvement of 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 program including one-month physical therapy (PT) only (A) followed by one-month spinal stimulation with PT (B). Between each intervention, washout periods of up to one-month may be used to determine any after-effect of the interventions. The AB or BA interventions will be repeated if the functional improvement does not reach a plateau during the first two month 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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Transcutaneous spinal stimulation Other: Physical Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Neuromuscular Recovery Scale [ Time Frame: 8-11 months ]
    Neuromuscular recovery scale is an assessment for sitting, standing and walking functions based on a comparison to pre-injury performance criteria or how a task was performed one day prior to spinal cord injury and without use of compensation strategies. The items consists of stand retraining, stand adaptability, step retraining, step adaptability, sit, reverse sit up, trunk extension in sitting, sit to stand , stand, walking, and upper limb functions. They are score the scale of 4 based on how close to the function in the pre-injured condition.


Secondary Outcome Measures :
  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 8-11 months ]
    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.

  2. Somatosensory evoked potentials [ Time Frame: 8-11 months ]
    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.

  3. Somatosensory evoked potentials [ Time Frame: 8-11 months ]
    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.

  4. Motor evoked potentials [ Time Frame: 8-11 months ]
    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.

  5. Motor evoked potentials [ Time Frame: 8-11 months ]
    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.

  6. Berg Balance Test [ Time Frame: 8-11 months ]
    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).

  7. Six-minute walk test [ Time Frame: 8-11 months ]
    Measurement of walking ability. The distance is reported in meter.

  8. Ten-minute walk test [ Time Frame: 8-11 months ]
    Measurement of walking ability. The walking speed is reported in meter per second.

  9. Kinetic and kinematic gait analysis using 3D camera system [ Time Frame: 8-11 months ]
    Measurement of leg function and walking ability. Joint angle is reported in degree angle.

  10. Kinetic and kinematic gait analysis using 3D camera system [ Time Frame: 8-11 months ]
    Measurement of leg function and walking ability. Velocity is reported in meter per second.

  11. Electromyography recording of LE and trunk muscles [ Time Frame: 8-11 months ]
    Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.

  12. Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire [ Time Frame: 8-11 months ]
    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.

  13. Spinal Cord Injury - Functional Index (SCI-FI) questionnaire [ Time Frame: 8-11 months ]
    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.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has spinal cord injury (T12 or higher level) 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 primary physician of the subject
  • Has 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, MS, 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, or 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 ≤ -2.0 in anteroposterior lumbar spine and/or proximal femur measured by DEXA (if participants are clear for other criteria and have not been examined by 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509558


Contacts
Contact: Soshi Samejima, DPT, MS 206 221-8961 soshis@uw.edu
Contact: Chet Moritz, PhD 206 221-2842 ctmoritz@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Soshi Samejima       soshis@uw.edu   
Contact: Chet Moritz       ctmoritz@uw.edu   
Principal Investigator: Chet Moritz, PhD         
Sponsors and Collaborators
University of Washington

Responsible Party: Chet Moritz, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03509558     History of Changes
Other Study ID Numbers: STUDY00003070
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chet Moritz, University of Washington:
Spinal electrical stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries