Testing a Non-Invasive Spinal Stimulation Device

NCT ID: NCT07217314

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2029-01-31

Brief Summary

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The purpose of this study is to compare an updated spinal stimulation device with the spinal stimulation device that is currently used. Spinal stimulation is often used in studies aimed at assisting individuals with a spinal cord injury. This device was updated to improve upon limitations in the currently used device.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Participants

Group Type EXPERIMENTAL

Spinal Stimulation

Intervention Type DEVICE

Participants will lay on their back and have small electrodes placed on the center of their backs and several leg muscles. The back electrodes, connected to a battery-operated unit, will send an electrical current to the spine. The leg electrodes will record muscle activity. This will take approximately 2 hours to complete on each day. The 2 hours includes set-up/placement of the electrodes, 4 trials of stimulation with breaks, and removal of electrodes after testing.

Interventions

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Spinal Stimulation

Participants will lay on their back and have small electrodes placed on the center of their backs and several leg muscles. The back electrodes, connected to a battery-operated unit, will send an electrical current to the spine. The leg electrodes will record muscle activity. This will take approximately 2 hours to complete on each day. The 2 hours includes set-up/placement of the electrodes, 4 trials of stimulation with breaks, and removal of electrodes after testing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Proficient in English
* Available for the testing session
* Able to give informed consent
* Able to tolerate spinal stimulation

Exclusion Criteria

* Pregnant (female only).
* Untreated severe and persistent problems regulating blood pressure, heart rate, or other automatic functions.
* Any past or present injury or disease to the nervous system
* Heart or lung disease that may interfere with stimulation
* A skin condition in any area that may affect the ability to receive stimulation
* Taking any medication that may affect the ability to receive spinal stimulation
* Ongoing drug abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gail Forrest

OTHER

Sponsor Role lead

Responsible Party

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Gail Forrest

Director, Tim and Caroline Reynolds Center for Spinal Stimulation

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Research Manager

Role: CONTACT

9733243557

Facility Contacts

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Research Manager

Role: primary

9733243557

Other Identifiers

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R-1283-24

Identifier Type: -

Identifier Source: org_study_id

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