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NCT06520020 · ClinicalTrials.gov registry record · NA

Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study

A NA study of Spinal Cord Stimulation and Cervical Myelopathy, sponsored by Francis Farhadi.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT06520020: Recruiting NA study of Spinal Cord Stimulation and Cervical Myelopathy, sponsored by Francis Farhadi.

NCT06520020 is a NA study of Spinal Cord Stimulation and Cervical Myelopathy that is actively recruiting participants, run by Francis Farhadi. The registered enrollment target is 30 participants, below the 2,769-participant average among 4 other Spinal Cord Stimulation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06520020, a NA study of Spinal Cord Stimulation and Cervical Myelopathy, is actively recruiting participants, sponsored by Francis Farhadi.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.

Primary Outcome

An empirically validated and open worksheet for evaluation of sensation from C2 to S4-5, and motor strength of all major limb myotomes from C5-T1 and L2-S1. This determines the neurologic level of injury (NLI) and severity of motor and sensory completeness, with sensorimotor complete, sensory incomplete, motor incomplete without anti-gravity strength, motor incomplete with anti-gravity strength, and no significant deficit.

Conditions Studied

Spinal Cord Stimulation Cervical Myelopathy Traumatic Spinal Cord Injury Electric Stimulation Therapy

Interventions

  • DEVICE Transcutaneous Spinal Cord Stimulation (Tc-SCS)

Study Locations (1)

Kentucky

  • University of Kentucky - Chandler Medical Center - Lexington

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-10-23
Est. Completion 2026-06-30
Phase NA
Francis Farhadi

8 total trials

What NCT06520020 shows while recruiting

NCT06520020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,769-participant average among 4 other Spinal Cord Stimulation trials with a reported enrollment target (99% lower).

The record links to 4 conditions, with Spinal Cord Stimulation appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Spinal Cord Stimulation (Tc-SCS) is the first listed.

NCT06520020 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT06520020 about?

NCT06520020 is a clinical study titled "Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study". The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diag...

What is the current status of trial NCT06520020?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-10-23. Estimated completion is 2026-06-30.

What conditions does trial NCT06520020 study?

This clinical trial studies the following conditions: Spinal Cord Stimulation, Cervical Myelopathy, Traumatic Spinal Cord Injury, Electric Stimulation Therapy.

What interventions are being tested in trial NCT06520020?

The interventions under investigation include: Transcutaneous Spinal Cord Stimulation (Tc-SCS) (DEVICE).

Who is sponsoring clinical trial NCT06520020?

This trial is sponsored by Francis Farhadi, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06520020 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06520020

Source: ClinicalTrials.gov NCT06520020, the US trial registry maintained by the National Library of Medicine. NCT06520020 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.