NCT04755699

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Recruiting now EARLY_PHASE1 Last updated 11 March 2026

What this trial tests

EARLY_PHASE1 trial testing Transcutaneous Electrical Stimulation in Healthy Volunteers in 64 participants. Currently enrolling.

Timeline

2 December 2020

Primary endpoint
31 December 2027

30 June 2028

Quick facts

Lead sponsor	Northwell Health
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	device feasibility
Enrollment	64
Start date	2 December 2020
Primary completion	31 December 2027
Estimated completion	30 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous Electrical Stimulation

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →
• Spinal Cord Injury — all drugs for Spinal Cord Injury →
• Stroke — all drugs for Stroke →
• Paralysis — all drugs for Paralysis →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy Volunteers or Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries.

In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities.

During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors.

The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Publications & conference data

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

1. Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study.
   Chandrasekaran S, Bhagat NA, Ramdeo R, Ebrahimi S, et al · · 2023 · cited 21× · PMID 37483349 · DOI 10.3389/fnins.2023.1210328
2. Case study: persistent recovery of hand movement and tactile sensation in peripheral nerve injury using targeted transcutaneous spinal cord stimulation.
   Chandrasekaran S, Bhagat NA, Ramdeo R, Ebrahimi S, et al · · 2023 · cited 3× · PMID 37529233 · DOI 10.3389/fnins.2023.1210544