NCT04302259 (ISI-C) is a NA clinical trial of Intelligent Spine Interface in Spinal Cord Injury, sponsored by Rhode Island Hospital.

Who is sponsoring NCT04302259?

NCT04302259 is sponsored by Rhode Island Hospital.

What drugs are being tested in NCT04302259?

Interventions in NCT04302259: Intelligent Spine Interface.

What condition does NCT04302259 study?

NCT04302259 studies Spinal Cord Injury.

Is NCT04302259 still recruiting?

NCT04302259 is currently active, enrolled. Last updated 10 March 2025.

Last reviewed 2025-03-10 · How we verify

NCT04302259: ISI-C

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intelligent Spine Interface, Clinical (ISI-C)

Active, enrolled NA Last updated 10 March 2025

What this trial tests

NA trial testing Intelligent Spine Interface in Spinal Cord Injury in 3 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2021

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	Rhode Island Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	3
Start date	1 September 2021
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across United States

Drugs / interventions tested

Intelligent Spine Interface

Conditions studied

Spinal Cord Injury — all drugs for Spinal Cord Injury →

Sponsor

Rhode Island Hospital

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs. This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting the glial-fibrotic scar microenvironment after spinal cord injury: From integrated protection to systematic regulation of regenerative balance.
Hou Z, Shang S, Sun H, He Y, et al · · 2026 · PMID 42212054 · DOI 10.1016/j.jot.2026.101120

Verify or expand the search:

Other recruiting trials for Spinal Cord Injury

Currently open trials in the same condition.

NCT07429305 — Combined Tibial Nerve Stimulation and Standing for People With SCI · NA · recruiting
NCT06410001 — CE-STAND: Cervical Epidural STimulation After Neurologic Damage · Phase 1, PHASE2 · recruiting
NCT05926596 — Leg Stretching Using an Exoskeleton on Demand for People With Spasticity · NA · recruiting
NCT06839300 — The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study · recruiting
NCT07036107 — A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the S · NA · recruiting

Other Rhode Island Hospital trials

Trials by the same sponsor.

NCT06747221 — Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya · NA · not yet recruiting
NCT07211087 — Improving the Treatment of Depression Among Youth With HIV · NA · not yet recruiting
NCT06754527 — Options for Navigating Talking About Risk and Adolescent Choices · NA · not yet recruiting
NCT07144631 — Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome · NA · recruiting
NCT06942455 — A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04302259 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rhode Island Hospital
Last refreshed: 10 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04302259.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing