Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Shepherd Center, Atlanta GA
Study ID
NCT06214208
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Spinal Stimulation — OTHER
    Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.

Study Details

The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.

Key Dates

Start date
Feb 19, 2024
Status verified
Oct 2025
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 30 Hz Frequency
    Intervention will be applied with a 30 Hz frequency.
  • Experimental: 50 Hz Frequency
    Intervention will be applied with a 50 Hz frequency.
  • Experimental: 80 Hz Frequency
    Intervention will be applied with an 80 Hz frequency.

Primary Outcome Measure

Pendulum Test [ Time Frame: 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shepherd Center, Inc.AtlantaGeorgia30309
Jaclyn MIller, PT, DPT
[email protected]
(404) 350-7638
Evan Sandler, PT, DPT
[email protected]
(404) 603-4175

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By research site
Shepherd Center, Inc.· Atlanta, GA

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