NCT03184792: ADDRESS

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

Completed NA Results posted Last updated 4 November 2025

What this trial tests

NA trial testing Transcutaneous spinal stimulation in Spinal Cord Injury Cervical in 15 participants. Completed in 30 December 2024.

Timeline

1 December 2017

Primary endpoint
30 August 2024

30 December 2024

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 December 2017
Primary completion	30 August 2024
Estimated completion	30 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous spinal stimulation
• Physical therapy

Conditions studied

• Spinal Cord Injury Cervical — all drugs for Spinal Cord Injury Cervical →
• Upper Extremity Dysfunction — all drugs for Upper Extremity Dysfunction →

Sponsor

University of Washington

Who can join

Adults 21 to 70, any sex, with Spinal Cord Injury Cervical or Upper Extremity Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) Primary · 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 an

Group	Value	95% CI
Physical Therapy only	4.5	± 4.1
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	19.4	± 6.3

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

Subscore 1: Myotomal-based Motor Examination

Group	Value	95% CI
Physical Therapy only	0.5	± 0.8
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	5.5	± 2.3

Subscale 2: The Dermatomal-based Sensory Examination

Group	Value	95% CI
Physical Therapy only	1.6	± 5.2
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	6.4	± 9.5

Grip and Pinch Strength Secondary · 6 months

Hand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated.

Group	Value	95% CI
Physical therapy only	3	± 2
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	12	± 4

Numeric Pain Rating Scale Secondary · 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.

Group	Value	95% CI
physical therapy only	4.0	± 1.1
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	2.0	± 0.5

Penn Spasm Score Secondary · 6 months

Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).

Group	Value	95% CI
Physical therapy only	1.5	± 0.5
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	1.0	± 0

Spinal Cord Independence Measure (SCIM) Secondary · 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.

Group	Value	95% CI
Physical therapy only	0.2	± 0.4
ranscutaneous Spinal Cord Stimulation combined with Physical Therapy	3.2	± 2.2

World Health Organization-Quality of Life - (WHO-QoL-BREF) Secondary · 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.

Group	Value	95% CI
Physical therapy only	4.3	± 7.7
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy	12.5	± 8.9

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials in Traumatic Spinal Cord Injury.
   Donovan J, Kirshblum S. · · 2018 · cited 68× · PMID 29736858 · DOI 10.1007/s13311-018-0632-5
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710