Spinal Cord InjuriesNCT06214208
Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury
A study testing Transcutaneous Spinal Stimulation in people with Spinal Cord Injuries, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous Spinal Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 un-treated or uncontrolled heart problems that the lead investigator believes could be affected by stimulation or affected by an increase in blood pressure.
- People with bone or joint problems that would make it hard to follow the study plan.
- Women who are pregnant or actively trying to become pregnant.
Show all 13Show fewer
- People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
- People with infection.
- People with skin that is broken or wounds in the area of the body where stimulation is applied.
- People who have or had certain types of cancer in the area of the body where stimulation will be applied.
- People who have had botulinum toxin or numbing shots in the test leg or spine in the last 6 months
- People who have had permanent spasticity treatment in the test leg or spine (like a certain type of surgery).
- Other health issues that the lead investigator things could make it unsafe for you to join the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shepherd Center, Inc.
Atlanta, Georgia, 30309
Jaclyn MIller, PT, DPT, (404) 350-7638, jaclyn.miller@shepherd.org
Evan Sandler, PT, DPT, (404) 603-4175, evan.sandler@Shepherd.org
About this study
Official title: Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcutaneous Spinal Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal StimulationOther
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 group | Role | What they receive |
|---|---|---|
| 30 Hz Frequency | Experimental | Intervention will be applied with a 30 Hz frequency. Receives: Other: Transcutaneous Spinal Stimulation |
| 50 Hz Frequency | Experimental | Intervention will be applied with a 50 Hz frequency. Receives: Other: Transcutaneous Spinal Stimulation |
| 80 Hz Frequency | Experimental | Intervention will be applied with an 80 Hz frequency. Receives: Other: Transcutaneous Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pendulum Test
During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer.
Measured: 15 minutes
Secondary outcomes (8)
Ankle Clonus Test
During the ankle clonus test, the participant will be seated at the edge of a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's leg above a box and then release the leg allowing the front of the foot to land on the edge of the box. This test will be video recorded and the movement of the ankle joint will be measured using software on the computer.
Measured: 15 minutes
Muscle activation
Participants will be asked to activate different leg muscles and produce the maximum amount of force possible. Muscle activation will be measured through sensors placed on the muscles and force production will be measured using a dynamometer.
Measured: 20 minutes
Posterior root muscle reflexes
Posterior root muscle reflexes will be used to measure spinal reflex excitability. These reflexes will also be used to determine the intensity of stimulation that is applied during the intervention (0.8x soleus reflex threshold). During this test, participants have a single electrode over the skin of the back (T11/12) and two electrodes over the stomach (umbilicus). Brief pulses of stimulation will be applied at gradually increasing intensities while measuring muscle responses in different leg muscles.
Measured: 25 minutes
Nociception/Pain
The investigators will measure nociception using the flexor reflex. The flexor reflex measures muscle responses to an unpleasant stimulus. Electrodes will be placed at the bottom of the foot. First, the investigators will measure muscle responses to a single stimulus (25 mA). Next, the investigators will measure muscle responses to 5 consecutive stimuli (25 mA). The investigators will then ask participants to rate the unpleasant stimulus on a scale of 0-10.
Measured: 15 minutes
Quality of Spasticity Questionnaire
The Qualities of Spasticity Survey is a self-report questionnaire that asks participants about the physical qualities of their spasticity and how it impacts daily life. Participants will be asked to report experience with spasticity over the past 48 hours.
Measured: 5 minutes
Modified Penn Spasm Frequency Scale
The Modified Penn Spasm Frequency Scale is a self-report questionnaire that asks participants to rate the frequency and severity of spasms during the last hour.
Measured: 2 minutes
Stimulation Tolerability Questionnaire
Participants will be asked to rate how tolerable the spinal stimulation was during the session and to describe specific sensations that contributed to this rating.
Measured: 2 minutes
Global Rating of Change Scale
Participants will be asked to rate how much their change in spasticity affects their daily life.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start19 Feb 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA
- Investigators
- Edelle C Field-Fote, PT, PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214208
- Sponsor's protocol ID
- 2111327
- Other IDs
- 1R01HD101812-01A1
- Status last verified
- Oct 2025
- First submitted
- 9 Jan 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
- ClinicalTrials.gov ID
- NCT06214208
- Acronym / sponsor ID
- 2111327
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 Hz Frequency | Experimental | Other: Transcutaneous Spinal StimulationIntervention will be applied with a 30 Hz frequency. |
| 50 Hz Frequency | Experimental | Other: Transcutaneous Spinal StimulationIntervention will be applied with a 50 Hz frequency. |
| 80 Hz Frequency | Experimental | Other: Transcutaneous Spinal StimulationIntervention will be applied with an 80 Hz frequency. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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 un-treated or uncontrolled heart problems that the lead investigator believes could be affected by stimulation or affected by an increase in blood pressure.
- People with bone or joint problems that would make it hard to follow the study plan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Spinal StimulationTranscutaneous 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. | Other | 30 Hz Frequency, 50 Hz Frequency, 80 Hz Frequency |
Primary outcome
Pendulum Test
Time frame: 15 minutes
During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer.
8 secondary outcomes
Ankle Clonus Test
Time frame: 15 minutes
Muscle activation
Time frame: 20 minutes
Posterior root muscle reflexes
Time frame: 25 minutes
Nociception/Pain
Time frame: 15 minutes
Quality of Spasticity Questionnaire
Time frame: 5 minutes
Modified Penn Spasm Frequency Scale
Time frame: 2 minutes
Stimulation Tolerability Questionnaire
Time frame: 2 minutes
Global Rating of Change Scale
Time frame: 1 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edelle C Field-Fote, PT, PhD principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Stimulation in people with Spinal Cord Injuries, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn Miller, PT, DPT (404-350-7638, jaclyn.miller@shepherd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pendulum Test (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.