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Electrical Spinal Stimulation for Spinal Cord Injury (ADDRESS Trial)
N/A
Waitlist Available
Led By Chet T Moritz, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new electrical stimulation device to see if it can improve hand motor and sensory function in people with traumatic or degenerative cervical spinal cord injury.
Who is the study for?
This trial is for adults aged 21-70 with a cervical spinal cord injury (C7 or higher) that's at least one year old. Participants should have some hand function issues but be able to do simple tasks and attend weekly therapy sessions. They must not have other major neurological diseases, uncontrolled health conditions like severe hypertension, autoimmune disorders, active cancer, recent botulinum toxin injections, implanted stimulators, or severe mental health issues.
What is being tested?
The study tests if transcutaneous cervical electrical stimulation combined with physical therapy can improve arm and hand functions in those with spinal injuries compared to physical therapy alone. It's a delayed cross-over design: participants first get one treatment then switch to the other. The total study lasts 6 months including baseline measurements, intervention period of 8 weeks and follow-up of 12 weeks.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the electrical stimulation device or muscle soreness from increased physical activity during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test)
Secondary study objectives
Grip and pinch strength
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Numeric Pain Rating Scale
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Physical therapy onlyActive Control1 Intervention
Physical therapy that targets rehabilitation of upper extremity functions
Group II: Transcutaneous spinal stimulation & Physical therapyActive Control2 Interventions
Transcutaneous cervical electrical stimulation combined with physical therapy that targets rehabilitation of upper extremity functions
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,816 Previous Clinical Trials
1,914,338 Total Patients Enrolled
Chet T Moritz, PhDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your spinal cord dysfunction or injury is caused by an autoimmune condition.You have a history of other neurological conditions like stroke, multiple sclerosis, or traumatic brain injury.You have nerve damage in your arms or legs due to conditions like diabetes or nerve compression.You have diseases like rheumatoid arthritis or systemic lupus erythematosus.You have severe medical conditions like uncontrolled high blood pressure, heart or lung disease, or uncontrolled blood clotting problems.You have cancer that is currently growing or causing symptoms.You received botulinum toxin injections in the last 6 months.You have a medical device implanted in your body, such as a pacemaker or cochlear implant.You have a history of alcohol or drug abuse.You have trouble with memory and thinking, as shown by a specific questionnaire.You have had a serious neck injury at least 1 year ago.You have an incomplete spinal cord injury classified as AIS C or D.You can do basic motor tasks with some guidance.You have a heart or muscle condition that would make it hard for you to fully participate in physical therapy.You have a broken bone that hasn't healed, a tight muscle or joint, a sore from pressure, or a urinary tract infection that might affect your ability to do arm exercises or tests.You have had surgery to transfer tendons or nerves in your arms.You are between 21 and 70 years old.You have trouble using your hands for everyday tasks like getting dressed or eating.You have been diagnosed with depression or anxiety based on specific questionnaires.You have been diagnosed with syringomyelia.
Research Study Groups:
This trial has the following groups:- Group 1: Physical therapy only
- Group 2: Transcutaneous spinal stimulation & Physical therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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