Clinical trial NCT06214208: Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury
Official title: Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-01-19
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Transcutaneous spinal stimulation (TSS) is a noninvasive electrical stimulation that is applied over the skin of the low back and stomach. In prior research studies, TSS has reduced spasticity without the negative side effects of drug therapies. Although research in TSS is growing, the best dosage of TSS remains unknown. The investigators want to further advance the effects of TSS by comparing three different frequencies. Frequency is the number of electrical pulses that are delivered over a period of time. Frequency can affect the activation of nerves and therefore affect the outcome of TSS. Participation in this study includes testing of the participants' spasticity, strength, and pain before and after 30 minutes of TSS.

Eligibility criteria: Inclusion Criteria:

* Participants must agree to allow use of health information.
* Participants should be 16 years old or older.
* Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.
* Objectively measurable spasticity in your legs.
* Participants must inform the investigators if there is a change in medications during the study.
* Participants must be able to follow instructions.
* Participants must be able to communicate if pain or discomfort is experienced.

Exclusion Criteria:

* People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
* People neurological problems other than SCI.
* People with an injury level is below T12.
* People with heart issues, such as atrial fibrillation.
* People with bone or joint problems that would make it hard to follow the study plan.
* Women who are pregnant.
* People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
* People with infection.
* People with skin that is broken.
* People who have or had certain types of cancer.
* People who have had long-lasting spasticity treatment (like botox or selective dorsal rhizotomy).

Primary outcomes:
measure: Pendulum Test
timeFrame: 15 minutes
Secondary outcomes:
measure: Ankle Clonus Test
timeFrame: 15 minutes
measure: Muscle activation
timeFrame: 20 minutes
measure: Posterior root muscle reflexes
timeFrame: 25 minutes
measure: Nociception/Pain
timeFrame: 15 minutes
measure: Quality of Spasticity Questionnaire
timeFrame: 5 minutes
measure: Modified Penn Spasm Frequency Scale
timeFrame: 2 minutes
measure: Stimulation Tolerability Questionnaire
timeFrame: 2 minutes
measure: Global Rating of Change Scale
timeFrame: 1 minute
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center, Inc.
state: Georgia
Study officials:
affiliation: Shepherd Center, Atlanta GA
name: Edelle C Field-Fote, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: