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Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.
Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that seems to have effects that are similar to drug therapy. Prior studies of TSS in persons with SCI suggest that TSS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition, sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration) | Experimental | Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
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| Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration) | Experimental | Transcutaneous spinal stimulation will be applied continuously at two sites at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
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| Intensity 3 (0.8x reflex threshold, burst, 30 minute duration) | Experimental | Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal stimulation | Device | Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic stimulation with a single round electrode as the cathode placed directly over the spine at the T11/T12 (and the lumbar spine for dual-site stimulation) spinous interspace, and two interconnected dispersive (reference) electrodes placed on the abdomen, lateral to the umbilicus. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (0.8x reflex threshold). Treatments will be a minimum of 48 hours apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pendulum Test | The pendulum test will be performed during which the participant will be positioned supine on a mat with the lower leg hanging over 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. Muscle activity during each maneuver will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of an electrogoniometer placed at the knee joint. | Before and Immediately after each intervention session through study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankle Clonus Test | The ankle clonus test will be performed during which 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. Muscle activity during each maneuver will be recorded using EMG of the tibialis anterior and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of an electrogoniometer placed at the ankle joint. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified SCI-SET | The Modified SCI-SET is a self-report questionnaire that asks participants to rate how their spasticity has impacted various aspects of their life over the past seven days. | Completed during the enrollment session only. |
Inclusion Criteria:
The participant must meet all of the following criteria to be eligible for the study:
Exclusion Criteria:
The presence of any one of the following criteria leads to exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Edelle C Field-Fote, PT, PhD | Shepherd Center, Atlanta GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd Center, Inc. | Atlanta | Georgia | 30309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39762915 | Derived | Thatcher KL, Nielsen KE, Sandler EB, Daliet OJ 4th, Iddings JA, Field-Fote EC. Optimizing transcutaneous spinal stimulation: excitability of evoked spinal reflexes is dependent on electrode montage. J Neuroeng Rehabil. 2025 Jan 6;22(1):2. doi: 10.1186/s12984-024-01524-5. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2025 | Apr 8, 2025 | 12 | ||
| Apr 3, 2026 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Before and Immediately after each intervention session through study completion, an average of 2 weeks |
| Change in posterior root muscle reflexes (PRMRs) | PRMRs will be assessed to identify the spinal stimulation threshold at which muscle activity occurs in the soleus (reflex threshold). Electrode placement as outlined for intervention will be followed for this assessment. Briefly, stimulating pulses of 1ms duration (applied via a Digitimer DS7A constant current stimulator) will be delivered through the stimulating electrodes and intensity will be gradually increased until a motor event is electrophysiologically observed in the soleus. This reflex threshold stimulation intensity will be utilized to set the parameters of the three tcSCS intervention sessions - 80% of reflex threshold (0.8xRT). | Before and Immediately after each intervention session through study completion, an average of 2 weeks |
| Change in Plantar Flexor Reflex Response | Muscle activity induced through noxious sensory input will be assessed through instrumented flexor reflex response. Flexor reflex response will be tested at 1.2x reflex threshold of the tibialis anterior for three stimulus trains. Then, the noxious sensory stimulus will be standardized through electrocutaneous stimulation to the plantar surface of the participant's foot (parameters: 25mA, 500Hz, 20ms train). Muscle activity after each stimulus will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity. | Before and Immediately after each intervention session through study completion, an average of 2 weeks |
| Stimulation Tolerability Questionnaire | Participants will be asked to rate how tolerable stimulation was during the session and to describe specific sensations that contributed to this rating. | Immediately following each intervention session through study completion, an average of 2 weeks. |
| Qualities of Spasticity Survey | 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 their experience with their spasticity over the past 48 hours. | Before and Immediately after each intervention session through study completion, an average of 2 weeks |
| Modified Penn Spasm Frequency Scale | The Modified Penn Spasm Frequency Scale is a self-report questionnaire which asks participants to rate the frequency and severity of their spasms during the last hour. | Before and four hours after each intervention session through study completion, an average of 2 weeks |
| Apr 23, 2026 |
| 13 |
| D014947 | Wounds and Injuries |