Spinal Cord InjuriesNCT04243044
Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI
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
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. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The participant must meet all of the following criteria to be eligible for the study:
- Ability and willingness to authorize the use of protected health information (PHI)
- Be 16 years of age or older
- Have a SCI with any severity classification (AIS A, B, C, or D) that occurred at least 3 months ago
- Have at least mild "spasticity" affecting lower extremity muscles, as indicated by a pendulum test first swing excursion angle of ≤ 77° or ≥ 5 beats of clonus on the ankle drop test
- Use of prescription medications is acceptable, as long as the dosage has not changed in the last 2 weeks and notification of medication changes is made during study participation
- Ability to follow multiple commands
- Ability to communicate pain or discomfort
Who cannot join
- The presence of any one of the following criteria leads to exclusion:
- Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Neurologic level below spinal level T12
- History of cardiovascular irregularities (e.g. atrial fibrillation)
- Active cancer or a history of cancer
- Orthopedic pathology that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
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- Use of semi-permanent or permanent anti-spasmodic treatment (i.e. botox, selective dorsal rhizotomy)
- Women who are pregnant, or who have reason to believe they are, or may become pregnant due to unknown risks to the fetus associated with TSS
- Persons who have implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g. baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
- Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment
- Skin irregularities, sensitivity, or lesions that would increase the risk of stimulation-associated adverse events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation
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.
Read the detailed description
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.
- 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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous spinal stimulation |
| 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. Receives: Device: Transcutaneous spinal stimulation |
| 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. Receives: Device: Transcutaneous spinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and four hours after each intervention session through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start8 Apr 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- 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
- NCT04243044
- Sponsor's protocol ID
- 1343378
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39762915
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. 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
- ClinicalTrials.gov ID
- NCT04243044
- Acronym / sponsor ID
- 1343378
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 27 Jan 2020 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration) | Experimental | Device: Transcutaneous spinal stimulationTranscutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
| Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration) | Experimental | Device: Transcutaneous spinal stimulationTranscutaneous spinal stimulation will be applied continuously at two sites at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
| Intensity 3 (0.8x reflex threshold, burst, 30 minute duration) | Experimental | Device: Transcutaneous spinal stimulationTranscutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Ability and willingness to authorize the use of protected health information (PHI)
- Be 16 years of age or older
- Have a SCI with any severity classification (AIS A, B, C, or D) that occurred at least 3 months ago
- Have at least mild "spasticity" affecting lower extremity muscles, as indicated by a pendulum test first swing excursion angle of ≤ 77° or ≥ 5 beats of clonus on the ankle drop test
- Use of prescription medications is acceptable, as long as the dosage has not changed in the last 2 weeks and notification of medication changes is made during study participation
Key exclusion criteria (11 listed)
- Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Neurologic level below spinal level T12
- History of cardiovascular irregularities (e.g. atrial fibrillation)
- Active cancer or a history of cancer
- Orthopedic pathology that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
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 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. | Device | Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration), Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration), Intensity 3 (0.8x reflex threshold, burst, 30 minute duration) |
Primary outcome
Change in Pendulum Test
Time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
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.
6 secondary outcomes
Change in Ankle Clonus Test
Time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Change in posterior root muscle reflexes (PRMRs)
Time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Change in Plantar Flexor Reflex Response
Time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Stimulation Tolerability Questionnaire
Time frame: Immediately following each intervention session through study completion, an average of 2 weeks.
Qualities of Spasticity Survey
Time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Modified Penn Spasm Frequency Scale
Time frame: Before and four hours after each intervention session through study completion, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 39762915Thatcher 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.
- 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. This study is not recruiting at the moment.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 7 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pendulum Test (time frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243044, which also lists 1 linked publication.
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 7 Mar 2024.