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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

ADDRESS Trial 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.Check my eligibility

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.See study design

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.

ADDRESS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test)

Secondary outcome measures

Grip and pinch strength

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

Numeric Pain Rating Scale

+3 more

ADDRESS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,742 Previous Clinical Trials

1,847,800 Total Patients Enrolled

Chet T Moritz, PhDPrincipal InvestigatorUniversity of Washington

Media Library

Transcutaneous Spinal Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT03184792 — N/A

Spinal Cord Injury Research Study Groups: Physical therapy only, Transcutaneous spinal stimulation & Physical therapy

Spinal Cord Injury Clinical Trial 2023: Transcutaneous Spinal Stimulation Highlights & Side Effects. Trial Name: NCT03184792 — N/A

Transcutaneous Spinal Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03184792 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for enrolment in this trial?

"Affirmative. Clinicaltrials.gov provides evidence that this research project is currently open to volunteers. The trial was first shared on December 27th 2016 and had its most recent update on March 29th 2022. So far, 10 individuals have been recruited from a single location for the study."

Answered by AI

Is this research opportunity open to adults aged 18 and above?

"The specified age range for enrolment in this research project is 21 to 70 years old."

Answered by AI

What criteria must individuals fulfill to participate in this clinical trial?

"This clinical trial is seeking 10 individuals in the age range of 21 to 70 with existing bodily wounds. To be eligible for the study, patients must have a stable medical history without cardiopulmonary complications nor frequent autonomic dysreflexia that would preclude them from participating in upper extremity rehabilitation or testing activities; they should also possess basic motor skills and adequate social support enabling them to attend between two and five weekly physical therapy sessions as well as assessment activities within the 6-month period of study duration. Additionally, it's required that applicants are literate English speakers who sustained an incomplete C7 spinal cord injury at least one year prior and"

Answered by AI

What is the total recruitment quota for this trial?

"Affirmative. Information hosted on clinicaltrials.gov reveals that this research, which was originally posted in December 2016, is currently soliciting participants. The project requires 10 individuals to be recruited from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

Chet Moritz 2016. "Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03184792.

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