Spinal Cord Injury Cervical, Upper Extremity Dysfunction
Conditions
Keywords
Spinal electrical stimulation
Brief summary
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network. This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury. The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.
Interventions
Non-invasive electrical stimulation of cervical spinal cord over the skin
OTHERPhysical therapy
Physical therapy to improve arm and hand functions
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into two groups: Group 1.) Six weeks of Physical therapy only (Arm A) as the first intervention and then 6 weeks of Transcutaneous spinal stimulation & Physical therapy (Arm B) as the second intervention. Group 2.) Six weeks of Transcutaneous spinal stimulation & Physical therapy (Arm B) as the first intervention, and then Physical therapy only (Arm A) as the second intervention.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Cervical (C7 or higher) spinal cord injury at least 1-year duration * Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D) * Between 21 and 70 years of age * Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding) * Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities * Capable of performing simple cued motor tasks * Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities * Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period. * Ability to read and speak English
Exclusion criteria
* Autoimmune etiology of spinal cord dysfunction/injury * History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc. * Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) * Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) * 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. * Active cancer * Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention * Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities * Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician * Pregnancy * Tendon or nerve transfer surgery in the upper limbs * Botulinum toxin injections in the prior 6 months * Dependent on ventilation support * Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc). * Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire * Diagnosed with syringomyelia * Alcohol and/or drug abuse. * Cognitive impairment based on Short Portable Mental Status Questionnaire * Unable to read and/or comprehend the consent form. * Unable to understand the instructions given as part of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) | 6 months | GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts). The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome. Score change before and after each intervention is calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip and Pinch Strength | 6 months | Hand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated. |
| Numeric Pain Rating Scale | 6 months | Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated. Zero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain. |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | 6 months | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes. Subscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes. |
| Spinal Cord Independence Measure (SCIM) | 6 months | Clinician-administered disability questionnaire for patients with spinal cord lesions. The total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated. |
| World Health Organization-Quality of Life - (WHO-QoL-BREF) | 6 months | Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated. |
| Penn Spasm Score | 6 months | Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2). |
Countries
United States
Participant flow
Recruitment details
We use advertisement flyers and information sheets that will be clearly displayed in the neurosurgery and rehabilitation outpatient departments at the University of Washington, for all to see. Recruitment began on December 1, 2017, and concluded on December 1, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator The sequence of cross-arm intervention for Group 1 will be as follows: Physical therapy only (Arm A) first and Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) second.
Physical Therapy only is the active comparator intervention. | 7 |
| Group 2 (Cross-over Intervention arm sequence: BA) - Experimental The sequence of cross-arm intervention for Group 2 will be as follows: Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) first and Physical therapy only (Arm A) second.
Transcutaneous Spinal Cord Stimulation, combined with physical therapy, is the experimental intervention. | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pandemic | 2 | 2 |
Baseline characteristics
| Characteristic | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 6 | 59 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 14 |
| International Standards for Neurological Classification of SCI (ISNCSCI) Subscale 1: Myotomal-based Motor Examination | 49.8 units on a scale STANDARD_DEVIATION 15 | 49.9 units on a scale STANDARD_DEVIATION 17.8 | 50.1 units on a scale STANDARD_DEVIATION 21.5 |
| International Standards for Neurological Classification of SCI (ISNCSCI) Subscale 2:Dermatomal-based Sensory Examination | 113.8 units on a scale STANDARD_DEVIATION 36.4 | 112.4 units on a scale STANDARD_DEVIATION 35.8 | 111.0 units on a scale STANDARD_DEVIATION 43.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 8 participants | 15 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)
GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts). The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome. Score change before and after each intervention is calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) | 4.5 score change before and after | Standard Deviation 4.1 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) | 19.4 score change before and after | Standard Deviation 6.3 |
p-value: <095% CI: [6.6, 12.4]ANOVA
p-value: 0.0195% CI: [3.7, 17]t-test, 2 sided
Secondary
Grip and Pinch Strength
Hand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | Grip and Pinch Strength | 3 kilogram | Standard Deviation 2 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | Grip and Pinch Strength | 12 kilogram | Standard Deviation 4 |
Secondary
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes. Subscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Therapy only | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Subscore 1: Myotomal-based Motor Examination | 0.5 score on a scale | Standard Deviation 0.8 |
| Physical Therapy only | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Subscale 2: The Dermatomal-based Sensory Examination | 1.6 score on a scale | Standard Deviation 5.2 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Subscore 1: Myotomal-based Motor Examination | 5.5 score on a scale | Standard Deviation 2.3 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Subscale 2: The Dermatomal-based Sensory Examination | 6.4 score on a scale | Standard Deviation 9.5 |
p-value: <0.05t-test, 2 sided
Secondary
Numeric Pain Rating Scale
Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated. Zero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | Numeric Pain Rating Scale | 4.0 score on a scale | Standard Deviation 1.1 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | Numeric Pain Rating Scale | 2.0 score on a scale | Standard Deviation 0.5 |
Secondary
Penn Spasm Score
Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | Penn Spasm Score | 1.5 score on a scale | Standard Deviation 0.5 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | Penn Spasm Score | 1.0 score on a scale | Standard Deviation 0 |
Secondary
Spinal Cord Independence Measure (SCIM)
Clinician-administered disability questionnaire for patients with spinal cord lesions. The total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | Spinal Cord Independence Measure (SCIM) | 0.2 score on a scale | Standard Deviation 0.4 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | Spinal Cord Independence Measure (SCIM) | 3.2 score on a scale | Standard Deviation 2.2 |
Secondary
World Health Organization-Quality of Life - (WHO-QoL-BREF)
Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy only | World Health Organization-Quality of Life - (WHO-QoL-BREF) | 4.3 score on a scale | Standard Deviation 7.7 |
| Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | World Health Organization-Quality of Life - (WHO-QoL-BREF) | 12.5 score on a scale | Standard Deviation 8.9 |