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NCT07204184 · ClinicalTrials.gov registry record · NA

Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

A NA study of Spinal Cord Injuries (Complete and Incomplete), sponsored by Maria Knikou, PT, MBA, PhD.

Recruiting
Registry status
NA
Development phase
36
Enrollment target
1
Study location

NCT07204184: Recruiting NA study of Spinal Cord Injuries (Complete and Incomplete), sponsored by Maria Knikou, PT, MBA, PhD.

NCT07204184 is a NA study of Spinal Cord Injuries (Complete and Incomplete) that is actively recruiting participants, run by Maria Knikou, PT, MBA, PhD. The registered enrollment target is 36 participants, below the 76-participant average among 3 other Spinal Cord Injuries (Complete and Incomplete) trials with a reported enrollment target (53% 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

NCT07204184, a NA study of Spinal Cord Injuries (Complete and Incomplete), is actively recruiting participants, sponsored by Maria Knikou, PT, MBA, PhD.

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

Study Summary

A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal). No single intervention is likely to significantly improve long-term function after SCI on its own. Rather, combinatorial treatments that work synergistically and can be used at different clinical settings is the answer to target recovery in people with SCI. The objective of this clinical trial is to develop a non-invasive combinatorial intervention that can be used worldwide in different clinical settings. The investigators will use cervical and lumbosacral transspinal stimulation to augment the benefits of locomotor training and affect vital body functions after SCI. The investigators will deliver non-invasive cervical and lumbosacral transspinal stimulation alone or with step training to improve upright posture, walking, bladder, sex, and bowel function in persons with incomplete SCI. The noninvasive nature of the intervention holds minimal risk that outweighs the benefits.

Primary Outcome

Investigators will deliver single pulses of 1 ms duration every 5 seconds at increasing intensities to the posterior tibial nerve behind the knee to assemble the soleus H-reflex recruitment curve. At least 50 responses will be recorded. From the recruitment curve, the investigators will estimate changes in the slope and stimulation intensities for reflex threshold.

Interventions

  • DEVICE Multisite transspinal stimulation at rest
  • DEVICE Multisite transspinal stimulation during robotic gait training

Study Locations (1)

New York

  • College of Staten Island (Building 5N-218) - Staten Island

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2026-02-19
Est. Completion 2028-06-30
Phase NA
Maria Knikou, PT, MBA, PhD

1 total trials

What NCT07204184 shows while recruiting

NCT07204184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 76-participant average among 3 other Spinal Cord Injuries (Complete and Incomplete) trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Spinal Cord Injuries (Complete and Incomplete) appearing as the primary indexed condition, and to 2 interventions - of which Multisite transspinal stimulation at rest is the first listed.

NCT07204184 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT07204184 about?

NCT07204184 is a clinical study titled "Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury". A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal). No singl...

What is the current status of trial NCT07204184?

This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2026-02-19. Estimated completion is 2028-06-30.

What conditions does trial NCT07204184 study?

This clinical trial studies the following conditions: Spinal Cord Injuries (Complete and Incomplete).

What interventions are being tested in trial NCT07204184?

The interventions under investigation include: Multisite transspinal stimulation at rest (DEVICE), Multisite transspinal stimulation during robotic gait training (DEVICE).

Who is sponsoring clinical trial NCT07204184?

This trial is sponsored by Maria Knikou, PT, MBA, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07204184 being conducted?

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

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Source: ClinicalTrials.gov NCT07204184, the US trial registry maintained by the National Library of Medicine. NCT07204184 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.