Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury (ADDRESS)
Primary Purpose
Spinal Cord Injury Cervical, Upper Extremity Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous spinal stimulation
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury Cervical focused on measuring Spinal electrical stimulation
Eligibility Criteria
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.
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transcutaneous spinal stimulation & Physical therapy
Physical therapy only
Arm Description
Transcutaneous cervical electrical stimulation combined with physical therapy that targets rehabilitation of upper extremity functions
Physical therapy that targets rehabilitation of upper extremity functions
Outcomes
Primary Outcome Measures
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, including strength (manual muscle strength testing), sensibility (Semmes Weinstein monofilament sensation test) and prehension (ability and performance to generate various grasp and pinch movements using water bottle, jar, key, pegs, coins and nuts).
Secondary Outcome Measures
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.
Grip and pinch strength
Hand strength measurement by grip and pinch dynamometry
Numeric Pain Rating Scale
Patient reported pain rating
Penn Spasm score
Patient reported spasm rating
Spinal Cord Independence Measure
Clinician-administered disability questionnaire for patients with spinal cord lesions
WHO-Quality of life - BREF
Patient reported quality of life scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03184792
Brief Title
Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Acronym
ADDRESS
Official Title
Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2016 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical, Upper Extremity Dysfunction
Keywords
Spinal electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous spinal stimulation & Physical therapy
Arm Type
Active Comparator
Arm Description
Transcutaneous cervical electrical stimulation combined with physical therapy that targets rehabilitation of upper extremity functions
Arm Title
Physical therapy only
Arm Type
Active Comparator
Arm Description
Physical therapy that targets rehabilitation of upper extremity functions
Intervention Type
Device
Intervention Name(s)
Transcutaneous spinal stimulation
Intervention Description
Non-invasive electrical stimulation of cervical spinal cord over the skin
Intervention Type
Other
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
Exercise therapy
Intervention Description
Physical therapy to improve arm and hand functions
Primary Outcome Measure Information:
Title
Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test)
Description
GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function, including strength (manual muscle strength testing), sensibility (Semmes Weinstein monofilament sensation test) and prehension (ability and performance to generate various grasp and pinch movements using water bottle, jar, key, pegs, coins and nuts).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Description
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.
Time Frame
6 months
Title
Grip and pinch strength
Description
Hand strength measurement by grip and pinch dynamometry
Time Frame
6 months
Title
Numeric Pain Rating Scale
Description
Patient reported pain rating
Time Frame
6 months
Title
Penn Spasm score
Description
Patient reported spasm rating
Time Frame
6 months
Title
Spinal Cord Independence Measure
Description
Clinician-administered disability questionnaire for patients with spinal cord lesions
Time Frame
6 months
Title
WHO-Quality of life - BREF
Description
Patient reported quality of life scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Inanici, MD, PhD
Phone
206 787-2692
Email
finanici@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chet Moritz, PhD
Phone
206 221-2842
Email
ctmoritz@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chet T Moritz, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Inanici
Email
finanici@uw.edu
First Name & Middle Initial & Last Name & Degree
Chet Moritz
Email
ctmoritz@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
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