Spinal Cord Injuries (Complete and Incomplete)NCT07792616
Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity
A study testing Transcutaneous spinal stimulation at 30 Hz, Transcutaneous spinal stimulation at 75 Hz and Tizanidine in people with Spinal Cord Injuries (Complete and Incomplete) and Spinal Cord Injury, run by University of Mississippi Medical Center at 2 sites in United States.
Trial summary
Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury, Spinal Cord Injury Cervical
- What is being tested?
- Transcutaneous spinal stimulation at 30 Hz, Transcutaneous spinal stimulation at 75 Hz and Tizanidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2022to 14 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- History of spinal cord injury (ASIA Impairment Scale grades A-D)
- Time since injury longer than six months
- The presence of at least mild spasticity (>3) in the lower limbs, as self-reported on the Numerical Rating Scale of spasticity severity from 0 (no spasticity) to 10 (spasticity as bad as you can imagine)
- Agreement to reduce antispastic medication, if needed
Who cannot join
- Neurological level of SCI below T11
- Ventilatory-dependent
- Suspected progression of SCI (e.g., syringomyelia)
- Rigidity, contraction, or passive range of motion of <40 deg in both knee joint
- Systolic blood pressure at rest <90 mm Hg
- Implanted active devices (e.g., ITB pumps)
Show all 13Show fewer
- Passive implants (plates, screws) between T10 and L3 vertebras
- Skin conditions precluding placement of electrodes
- Skin breakdown on their sacrum, ischii or lower extremities
- Ongoing infections
- Pregnancy
- Difficulty following instructions
- Other medical risks/contraindications as determined by the study physicians.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methodist Rehabilitation
Jackson, Mississippi, 39216
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects.
This study examines a non-surgical method called transcutaneous spinal stimulation. Surface electrodes are placed on the lower back and on the abdomen, and an electrical current is passed between them to activate nerve fibers entering the spinal cord.
Read more
Adults who have had a spinal cord injury and have muscle stiffness or spasms in the legs may participate. Each participant takes part in all parts of the study and serves as their own comparison. Participants attend four visits at one study site, about one week apart. The first visit is for consent and a clinical examination. At each of the next three visits, the participant receives one capsule containing tizanidine, baclofen, or an inactive substance (placebo), in an order assigned by chance. One hour later, the participant receives two 15-minute periods of spinal stimulation, one at 30 pulses per second and one at 75 pulses per second, also in an order assigned by chance. Neither the participant nor the person conducting the testing knows which capsule was taken.
Leg reflexes, muscle activity, and knee movement are measured before the capsule is taken, one hour after it is taken, during each period of stimulation, and after each period of stimulation. Clinical scales for stiffness and spasms are also scored. The study compares the two stimulation rates, compares stimulation with each medicine given alone, and examines whether adding stimulation to a medicine has a larger effect than stimulation alone.
- Conditions
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injuries, Spasticity
- Being tested
- Transcutaneous spinal stimulation at 30 Hz, Transcutaneous spinal stimulation at 75 Hz, Tizanidine, Baclofen, Placebo
- Keywords
- Spinal Cord Injury, Spasticity, Transcutaneous spinal stimulation, Transcutaneous spinal cord stimulation, Neuromodulation, Electrical stimulation, Posterior root reflex, Flexion withdrawal reflex, Baclofen, Tizanidine, Lower extremity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity, Spasm, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal stimulation at 30 HzOther
Transcutaneous spinal stimulation is a non-invasive method that delivers electrical current through surface electrodes to activate afferent fibers in the lumbosacral posterior roots. A self-adhesive electrode array is placed midline over the T11-T12 spinous processes, and a pair of interconnected large electrodes is placed paraumbilically to serve as the counter electrode. Symmetric biphasic pulses of 500 microseconds per phase are delivered by a current-controlled stimulator at a constant intensity set individually below the motor threshold (determined from posterior root reflex recruitment curves) and not exceeding the maximum tolerable intensity. The stimulation frequency is 30 Hz, and the block lasts 15 minutes continuously.
Transcutaneous spinal stimulation at 75 HzOther
Transcutaneous spinal stimulation is a non-invasive method that delivers electrical current through surface electrodes to activate afferent fibers in the lumbosacral posterior roots. A self-adhesive electrode array is placed midline over the T11-T12 spinous processes, and a pair of interconnected large electrodes is placed paraumbilically to serve as the counter electrode. Symmetric biphasic pulses of 500 microseconds per phase are delivered by a current-controlled stimulator at a constant intensity set individually below the motor threshold (determined from posterior root reflex recruitment curves) and not exceeding the maximum tolerable intensity. The stimulation frequency is 75 Hz, and the block lasts 15 minutes continuously.
TizanidineDrug
Tizanidine is an alpha-2 adrenergic agonist used to reduce spasticity. A generic tablet is crushed by the study pharmacist, mixed with lactose powder, and packed into a capsule identical in appearance to the baclofen and placebo capsules. Participants receive a single oral dose of 2 mg at one of the three data collection visits, and a member of the study team witnesses intake. Assessment is repeated one hour after intake, coinciding with the expected peak plasma concentration.
BaclofenDrug
Baclofen is a gamma-aminobutyric acid type B receptor agonist used to reduce spasticity. A generic tablet is crushed by the study pharmacist, mixed with lactose powder, and packed into a capsule identical in appearance to the tizanidine and placebo capsules. Participants receive a single oral dose of 20 mg at one of the three data collection visits, and a member of the study team witnesses intake. Assessment is repeated one hour after intake, coinciding with the expected peak plasma concentration.
PlaceboDrug
The placebo capsule contains lactose powder only and is identical in appearance to the tizanidine and baclofen capsules. It is prepared by the study pharmacist and given as a single oral dose at one of the three data collection visits, with intake witnessed by a member of the study team. The placebo visit provides the reference condition for the comparison between the two stimulation frequencies.
| Study group | Role | What they receive |
|---|---|---|
| Spinal stimulation with tizanidine, baclofen, or placebo | Experimental | All participants receive every study condition in a within-subjects crossover design. Each participant attends one evaluation visit, followed by three data-collection visits spaced about one week apart. At each data collection visit, the participant takes a single oral capsule containing tizanidine 2 mg, baclofen 20 mg, or matched placebo, in an order assigned at random across the three visits. One hour after intake, the participant receives two 15-minute blocks of continuous transcutaneous spinal stimulation, one at 30 Hz and one at 75 Hz, in an order assigned at random within the visit. Stimulation intensity is set individually below the motor threshold determined from posterior root reflex recruitment curves. Neurophysiological and clinical assessments are performed before drug intake, one hour after drug intake, during the middle 5 minutes of each stimulation block, and 5 minutes after the end of each stimulation block. Receives: Other: Transcutaneous spinal stimulation at 30 Hz; Other: Transcutaneous spinal stimulation at 75 Hz; Drug: Tizanidine; Drug: Baclofen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in soleus posterior root reflex peak-to-peak amplitude
The soleus posterior root reflex is evoked by transcutaneous spinal stimulation. Five reflexes are recorded at least 5 seconds apart to avoid homosynaptic suppression. Peak-to-peak amplitude is measured in a window from 15 to 50 milliseconds after the stimulation artifact and averaged over the five repetitions, in millivolts. The outcome is the change in mean posterior root reflex amplitude from the pre-drug baseline, compared between the 30 Hz and 75 Hz stimulation blocks and between stimulation and drug conditions.
Measured: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
Change from baseline in flexion withdrawal reflex amplitude
The flexion withdrawal reflex is elicited by a train of 11 pulses, delivered through an electrode over the medial arch of the foot, using 1-millisecond monophasic pulses separated by 2 milliseconds, at 1.5 and 3 times the reflex threshold, with three stimuli at least 20 seconds apart to avoid habituation. The root mean square value of electromyographic activity in the tibialis anterior is calculated in a window from 50 to 200 milliseconds after the stimulation artifact. The outcome is the change in the root mean square value from the pre-drug baseline.
Measured: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
Secondary outcomes (4)
Change from baseline in normalized posterior root reflex amplitude
Posterior root reflex amplitudes in 8 muscles, bilaterally, recorded before and during transcutaneous spinal stimulation are normalized to the maximum response amplitude obtained from that muscle's recruitment curve, then averaged across all recorded muscles. The outcome is the change in the mean normalized amplitude relative to the pre-drug baseline, expressed as a proportion of the muscle-specific maximum response
Measured: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
Change from baseline in Spinal Cord Assessment Tool for Spastic Reflexes sum score
The Spinal Cord Assessment Tool for Spastic Reflexes grades three types of spastic motor behavior: ankle clonus, flexor spasms, and extensor spasms, scored bilaterally. The sum score ranges from 0 to 18, where 0 indicates no appearance of spasticity and higher scores indicate more severe spastic reflex behavior. Testing is performed with the participant supine. The outcome is the change in sum score from the pre-drug baseline.
Measured: Baseline before drug intake (A0), 60 minutes after drug intake and before stimulation (A1), and 5 minutes after the second stimulation block ends (A5).
Change from baseline in Modified Ashworth Scale sum score
The Modified Ashworth Scale grades resistance to passive movement in the hip adductors, knee extensors, knee flexors, and ankle plantar flexors bilaterally. Individual muscle scores range from 0 to 4, with a grade of 1+ scored as 1.5. The sum score across the 10 tested muscle groups ranges from 0 to 40, where 0 indicates no increase in muscle tone in any tested muscle group and higher scores indicate greater muscle tone. Testing is performed with the participant supine. The outcome is the change in sum score from the pre-drug baseline.
Measured: Baseline before drug intake (A0), 60 minutes after drug intake and before stimulation (A1), and 5 minutes after the second stimulation block ends (A5).
Change from baseline in pendulum test spasticity index
The examiner brings the lower leg to maximal extension, releases it, and allows it to swing freely to rest, three times per leg at 30 second intervals, with knee joint angle. The spasticity index is calculated from three angles: the initial horizontal leg position, the angle of first reversal from flexion to extension, and the final resting angle, as (first reversal angle minus start angle) divided by 1.6 times (resting angle minus start angle). Values above 1 denote non-spastic conditions and 0 denotes extreme spasticity. The outcome is the change in the spasticity index from the pre-drug baseline.
Measured: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start13 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion14 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (Complete and Incomplete)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant receives every study condition in a within-subjects crossover design. Across three data collection visits spaced about one week apart, participants receive a single oral dose of tizanidine, baclofen, or placebo, one per visit, in a random order. Within each visit, two 15-minute blocks of transcutaneous spinal stimulation at 30 Hz and at 75 Hz are delivered in an order assigned at random. Each participant therefore serves as his or her own control across six drug-by-frequency conditions, thereby reducing outcome variability and limiting the influence of injury and spasticity severity as confounders.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Rehabilitation Center
- Responsible party
- Principal investigator, Matthias J. Krenn, PhD, University of Mississippi Medical Center
- Investigators
- Matthias J. Krenn, Ph.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792616
- Sponsor's protocol ID
- UMMC-IRB-2022-197
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity
- ClinicalTrials.gov ID
- NCT07792616
- Acronym / sponsor ID
- UMMC-IRB-2022-197
- Conditions
- Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injuries, Spasticity
- Keywords
- Spinal Cord Injury, Spasticity, Transcutaneous spinal stimulation, Transcutaneous spinal cord stimulation, Neuromodulation, Electrical stimulation, Posterior root reflex, Flexion withdrawal reflex
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Methodist Rehabilitation Center
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 14 Jul 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects.
This study examines a non-surgical method called transcutaneous spinal stimulation. Surface electrodes are placed on the lower back and on the abdomen, and an electrical current is passed between them to activate nerve fibers entering the spinal cord.
Adults who have had a spinal cord injury and have muscle stiffness or spasms in the legs may participate. Each participant takes part in all parts of the study and serves as their own comparison. Participants attend four visits at one study site, about one week apart. The first visit is for consent and a clinical examination. At each of the next three visits, the participant receives one capsule containing tizanidine, baclofen, or an inactive substance (placebo), in an order assigned by chance. One hour later, the participant receives two 15-minute periods of spinal stimulation, one at 30 pulses per second and one at 75 pulses per second, also in an order assigned by chance. Neither the participant nor the person conducting the testing knows which capsule was taken.
Leg reflexes, muscle activity, and knee movement are measured before the capsule is taken, one hour after it is taken, during each period of stimulation, and after each period of stimulation. Clinical scales for stiffness and spasms are also scored. The study compares the two stimulation rates, compares stimulation with each medicine given alone, and examines whether adding stimulation to a medicine has a larger effect than stimulation alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant receives every study condition in a within-subjects crossover design. Across three data collection visits spaced about one week apart, participants receive a single oral dose of tizanidine, baclofen, or placebo, one per visit, in a random order. Within each visit, two 15-minute blocks of transcutaneous spinal stimulation at 30 Hz and at 75 Hz are delivered in an order assigned at random. Each participant therefore serves as his or her own control across six drug-by-frequency conditions, thereby reducing outcome variability and limiting the influence of injury and spasticity severity as confounders.
| Arm | Type | Receives |
|---|---|---|
| Spinal stimulation with tizanidine, baclofen, or placebo | Experimental | Other: Transcutaneous spinal stimulation at 30 Hz, Other: Transcutaneous spinal stimulation at 75 Hz, Drug: Tizanidine, Drug: Baclofen, Drug: PlaceboAll participants receive every study condition in a within-subjects crossover design. Each participant attends one evaluation visit, followed by three data-collection visits spaced about one week apart. At each data collection visit, the participant takes a single oral capsule containing tizanidine 2 mg, baclofen 20 mg, or matched placebo, in an order assigned at random across the three visits. One hour after intake, the participant receives two 15-minute blocks of continuous transcutaneous spinal stimulation, one at 30 Hz and one at 75 Hz, in an order assigned at random within the visit. Stimulation intensity is set individually below the motor threshold determined from posterior root reflex recruitment curves. Neurophysiological and clinical assessments are performed before drug intake, one hour after drug intake, during the middle 5 minutes of each stimulation block, and 5 minutes after the end of each stimulation block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- History of spinal cord injury (ASIA Impairment Scale grades A-D)
- Time since injury longer than six months
- The presence of at least mild spasticity (>3) in the lower limbs, as self-reported on the Numerical Rating Scale of spasticity severity from 0 (no spasticity) to 10 (spasticity as bad as you can imagine)
- Agreement to reduce antispastic medication, if needed
Key exclusion criteria (13 listed)
- Neurological level of SCI below T11
- Ventilatory-dependent
- Suspected progression of SCI (e.g., syringomyelia)
- Rigidity, contraction, or passive range of motion of <40 deg in both knee joint
- Systolic blood pressure at rest <90 mm Hg
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 stimulation at 30 HzTranscutaneous spinal stimulation is a non-invasive method that delivers electrical current through surface electrodes to activate afferent fibers in the lumbosacral posterior roots. A self-adhesive electrode array is placed midline over the T11-T12 spinous processes, and a pair of interconnected large electrodes is placed paraumbilically to serve as the counter electrode. Symmetric biphasic pulses of 500 microseconds per phase are delivered by a current-controlled stimulator at a constant intensity set individually below the motor threshold (determined from posterior root reflex recruitment curves) and not exceeding the maximum tolerable intensity. The stimulation frequency is 30 Hz, and the block lasts 15 minutes continuously. | Other | Spinal stimulation with tizanidine, baclofen, or placebo |
| Transcutaneous spinal stimulation at 75 HzTranscutaneous spinal stimulation is a non-invasive method that delivers electrical current through surface electrodes to activate afferent fibers in the lumbosacral posterior roots. A self-adhesive electrode array is placed midline over the T11-T12 spinous processes, and a pair of interconnected large electrodes is placed paraumbilically to serve as the counter electrode. Symmetric biphasic pulses of 500 microseconds per phase are delivered by a current-controlled stimulator at a constant intensity set individually below the motor threshold (determined from posterior root reflex recruitment curves) and not exceeding the maximum tolerable intensity. The stimulation frequency is 75 Hz, and the block lasts 15 minutes continuously. | Other | Spinal stimulation with tizanidine, baclofen, or placebo |
| TizanidineTizanidine is an alpha-2 adrenergic agonist used to reduce spasticity. A generic tablet is crushed by the study pharmacist, mixed with lactose powder, and packed into a capsule identical in appearance to the baclofen and placebo capsules. Participants receive a single oral dose of 2 mg at one of the three data collection visits, and a member of the study team witnesses intake. Assessment is repeated one hour after intake, coinciding with the expected peak plasma concentration. | Drug | Spinal stimulation with tizanidine, baclofen, or placebo |
| BaclofenBaclofen is a gamma-aminobutyric acid type B receptor agonist used to reduce spasticity. A generic tablet is crushed by the study pharmacist, mixed with lactose powder, and packed into a capsule identical in appearance to the tizanidine and placebo capsules. Participants receive a single oral dose of 20 mg at one of the three data collection visits, and a member of the study team witnesses intake. Assessment is repeated one hour after intake, coinciding with the expected peak plasma concentration. | Drug | Spinal stimulation with tizanidine, baclofen, or placebo |
| PlaceboThe placebo capsule contains lactose powder only and is identical in appearance to the tizanidine and baclofen capsules. It is prepared by the study pharmacist and given as a single oral dose at one of the three data collection visits, with intake witnessed by a member of the study team. The placebo visit provides the reference condition for the comparison between the two stimulation frequencies. | Drug | Spinal stimulation with tizanidine, baclofen, or placebo |
Primary outcome
Change from baseline in soleus posterior root reflex peak-to-peak amplitude
Time frame: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
The soleus posterior root reflex is evoked by transcutaneous spinal stimulation. Five reflexes are recorded at least 5 seconds apart to avoid homosynaptic suppression. Peak-to-peak amplitude is measured in a window from 15 to 50 milliseconds after the stimulation artifact and averaged over the five repetitions, in millivolts. The outcome is the change in mean posterior root reflex amplitude from the pre-drug baseline, compared between the 30 Hz and 75 Hz stimulation blocks and between stimulation and drug conditions.
Change from baseline in flexion withdrawal reflex amplitude
Time frame: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
The flexion withdrawal reflex is elicited by a train of 11 pulses, delivered through an electrode over the medial arch of the foot, using 1-millisecond monophasic pulses separated by 2 milliseconds, at 1.5 and 3 times the reflex threshold, with three stimuli at least 20 seconds apart to avoid habituation. The root mean square value of electromyographic activity in the tibialis anterior is calculated in a window from 50 to 200 milliseconds after the stimulation artifact. The outcome is the change in the root mean square value from the pre-drug baseline.
4 secondary outcomes
Change from baseline in normalized posterior root reflex amplitude
Time frame: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
Change from baseline in Spinal Cord Assessment Tool for Spastic Reflexes sum score
Time frame: Baseline before drug intake (A0), 60 minutes after drug intake and before stimulation (A1), and 5 minutes after the second stimulation block ends (A5).
Change from baseline in Modified Ashworth Scale sum score
Time frame: Baseline before drug intake (A0), 60 minutes after drug intake and before stimulation (A1), and 5 minutes after the second stimulation block ends (A5).
Change from baseline in pendulum test spasticity index
Time frame: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).
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 28 Aug 2026.
- 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.
Matthias J. Krenn, Ph.D. principal investigator
University of Mississippi Medical Center
2 sites 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 at 30 Hz, Transcutaneous spinal stimulation at 75 Hz and Tizanidine in people with Spinal Cord Injuries (Complete and Incomplete) and Spinal Cord Injury, run by University of Mississippi Medical Center at 2 sites 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 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 from baseline in soleus posterior root reflex peak-to-peak amplitude (time frame: Baseline before drug intake (A0); 60 minutes after drug intake and before stimulation (A1); during the 15-minute stimulation block (A2 and A4); and 5 minutes after each stimulation block ends (A3 and A5).). The study lists 2 primary outcomes in all. 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 28 Aug 2026.