Spinal Cord InjuriesEarly Phase 1NCT06274021
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
A Early Phase 1 study testing Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz and Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen in people with Spinal Cord Injuries and Spinal Cord Injury, run by University of Mississippi Medical Center at 2 sites in United States.
Trial summary
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical
- What is being tested?
- Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz and Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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 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
- Time since diagnosis longer than six months
- Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity [range from 0 to 10])
- If needed, agreement to reduce antispastic medication
Who cannot join
- Neurological level of spinal cord injury below T11
- Ventilatory-dependent
- Change in neurological status over the past 2 months
- Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
- Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
- Systolic blood pressure at rest lower than 90 mm Hg
Show all 15Show fewer
- Implanted active devices (e.g., intrathecal baclofen pumps)
- Passive implants (plates, screws) between T11 and L2 vertebras
- Skin conditions precluding placement of electrodes
- Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
- Receiving antibiotics for infections
- Pregnancy
- Difficulty following instructions
- Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study
- Other medical risks/contraindications as determined by the study physicians
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Methodist Rehabilitation Center
Jackson, Mississippi, 39216
Dobrivoje S Stokic, MD, DSc, 601-364-3314, dstokic@mmrcrehab.org
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Matthias J Krenn, PhD, 601-364-3413, mkrenn@umc.edu
About this study
Official title: Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.
The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.
Read the detailed description
The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes:
- Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine.
- Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone.
Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
- Being tested
- Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz, Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, Sham transcutaneous spinal stimulation
- Keywords
- Spinal Cord Injury, Neuromodulation, Electrical Stimulation, Spinal Cord Stimulation, Spasticity, Transcutaneous Spinal Stimulation, Lower extremity, Transcutaneous spinal cord stimulation, Paralysis, Spinal reflex
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal stimulation at 100 HzDevice
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 100 Hz, performed at a sub-motor threshold for 30 minutes.
Transcutaneous spinal stimulation at 50 HzDevice
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.
Transcutaneous spinal stimulation at 50 Hz and single dose of baclofenCombination product
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.
Study participants will receive a single dose of baclofen, a centrally-acting muscle relaxant belonging to the class of gamma-aminobutyric acid (GABA) analogs. Its primary mechanism involves acting on the GABA receptors in the brain and spinal cord to decrease spasticity. Participants will receive baclofen orally at a single dose of 10 mg.
Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidineCombination product
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.
Study participants will receive a medication called tizanidine, which is an alpha-2 adrenergic agonist. This medication works by inhibiting presynaptic motor neurons, resulting in a reduction of muscle spasticity. It is commonly used to manage spasticity caused by neurological disorders. Each participant will be given a single oral dose of 4 mg of tizanidine as part of this trial.
Sham transcutaneous spinal stimulationDevice
Sham Transcutaneous spinal stimulation (TSS) involves placing two surface electrodes midline on the lower back (T11-12 spinal processes). The stimulation frequency during the intervention is 50 Hz, performed for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo | Experimental | Each participant will receive five distinct interventions:
* Transcutaneous spinal stimulation at 100 Hz for 30 minutes with a placebo
* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a placebo
* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose baclofen
* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose tizanidine
* Transcutaneous spinal stimulation (sham) for 30 minutes with a placebo Receives: Device: Transcutaneous spinal stimulation at 100 Hz; Device: Transcutaneous spinal stimulation at 50 Hz; Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen; Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine; Device: Sham transcutaneous spinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
Change in area under the recruitment curve of PRRs after the intervention compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Measured: Baseline and at post-intervention (100 minutes)
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
Change in the amplitude of the FWR response after the intervention compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Measured: Baseline and at post-intervention (100 minutes)
Change from baseline of stretch reflex (SR) response amplitude.
Change in the amplitude of the SR response after the intervention compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
Measured: Baseline and at post-intervention (100 minutes)
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),
Change in cumulative scores of Modified Ashworth Scale in bilaterally five lower extremity muscles (score range: 0 to 40, where higher scores denote worsening outcomes) before and after the 30-minute intervention. The Modified Ashworth Scale is a clinically validated tool that measures resistance during passive soft-tissue stretching and indicates spasticity.
Measured: Baseline and at post-intervention (100 minutes)
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).
Change in the cumulative score of the Spinal Cord Assessment Tool for Spastic Reflexes, encompassing clonus, flexor spasms, and extensor spasms bilaterally, with a scoring range from 0 to 18, where higher scores denote worsening outcomes. The Spinal Cord Assessment Tool for Spastic Reflexes is a clinical tool designed to evaluate spastic reflexes in individuals with spinal cord injury specifically. It quantitatively measures the severity and pattern of spasticity by assessing involuntary muscle contractions in response to external stimuli.
Measured: Baseline and at post-intervention (100 minutes)
Secondary outcomes (3)
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
Change in area under the recruitment curve of PRRs during transcutaneous spinal stimulation compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Measured: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
Change in the amplitude of the FWR response during transcutaneous spinal stimulation compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Measured: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Change from baseline of stretch reflex (SR) response amplitude.
Change in the amplitude of the SR response during transcutaneous spinal stimulation compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
Measured: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Rehabilitation Center, The Craig H. Neilsen Foundation
- 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
- NCT06274021
- Sponsor's protocol ID
- UMMC-IRB-2023-125
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation
- ClinicalTrials.gov ID
- NCT06274021
- Acronym / sponsor ID
- UMMC-IRB-2023-125
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
- Keywords
- Spinal Cord Injury, Neuromodulation, Electrical Stimulation, Spinal Cord Stimulation, Spasticity, Transcutaneous Spinal Stimulation, Lower extremity, Transcutaneous spinal cord stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Methodist Rehabilitation Center, The Craig H. Neilsen Foundation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 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.
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.
The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.
Detailed description
The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes:
- Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine.
- Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone.
Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo | Experimental | Device: Transcutaneous spinal stimulation at 100 Hz, Device: Transcutaneous spinal stimulation at 50 Hz, Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, Device: Sham transcutaneous spinal stimulationEach participant will receive five distinct interventions: * Transcutaneous spinal stimulation at 100 Hz for 30 minutes with a placebo * Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a placebo * Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose baclofen * Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose tizanidine * Transcutaneous spinal stimulation (sham) for 30 minutes with a placebo |
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
- Time since diagnosis longer than six months
- Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity [range from 0 to 10])
- If needed, agreement to reduce antispastic medication
Key exclusion criteria (15 listed)
- Neurological level of spinal cord injury below T11
- Ventilatory-dependent
- Change in neurological status over the past 2 months
- Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
- Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
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 100 HzTranscutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 100 Hz, performed at a sub-motor threshold for 30 minutes. | Device | Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo |
| Transcutaneous spinal stimulation at 50 HzTranscutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes. | Device | Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo |
| Transcutaneous spinal stimulation at 50 Hz and single dose of baclofenTranscutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes. Study participants will receive a single dose of baclofen, a centrally-acting muscle relaxant belonging to the class of gamma-aminobutyric acid (GABA) analogs. Its primary mechanism involves acting on the GABA receptors in the brain and spinal cord to decrease spasticity. Participants will receive baclofen orally at a single dose of 10 mg. | Combination product | Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo |
| Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidineTranscutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes. Study participants will receive a medication called tizanidine, which is an alpha-2 adrenergic agonist. This medication works by inhibiting presynaptic motor neurons, resulting in a reduction of muscle spasticity. It is commonly used to manage spasticity caused by neurological disorders. Each participant will be given a single oral dose of 4 mg of tizanidine as part of this trial. | Combination product | Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo |
| Sham transcutaneous spinal stimulationSham Transcutaneous spinal stimulation (TSS) involves placing two surface electrodes midline on the lower back (T11-12 spinal processes). The stimulation frequency during the intervention is 50 Hz, performed for 30 minutes. | Device | Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo |
Primary outcome
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
Time frame: Baseline and at post-intervention (100 minutes)
Change in area under the recruitment curve of PRRs after the intervention compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
Time frame: Baseline and at post-intervention (100 minutes)
Change in the amplitude of the FWR response after the intervention compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Change from baseline of stretch reflex (SR) response amplitude.
Time frame: Baseline and at post-intervention (100 minutes)
Change in the amplitude of the SR response after the intervention compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),
Time frame: Baseline and at post-intervention (100 minutes)
Change in cumulative scores of Modified Ashworth Scale in bilaterally five lower extremity muscles (score range: 0 to 40, where higher scores denote worsening outcomes) before and after the 30-minute intervention. The Modified Ashworth Scale is a clinically validated tool that measures resistance during passive soft-tissue stretching and indicates spasticity.
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).
Time frame: Baseline and at post-intervention (100 minutes)
Change in the cumulative score of the Spinal Cord Assessment Tool for Spastic Reflexes, encompassing clonus, flexor spasms, and extensor spasms bilaterally, with a scoring range from 0 to 18, where higher scores denote worsening outcomes. The Spinal Cord Assessment Tool for Spastic Reflexes is a clinical tool designed to evaluate spastic reflexes in individuals with spinal cord injury specifically. It quantitatively measures the severity and pattern of spasticity by assessing involuntary muscle contractions in response to external stimuli.
3 secondary outcomes
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
Time frame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
Time frame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Change from baseline of stretch reflex (SR) response amplitude.
Time frame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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 Early Phase 1 study testing Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz and Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen in people with Spinal Cord Injuries 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 15 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias J Krenn, Ph.D. (601-364-3413, mkrenn@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of posterior root reflexes (PRRs) recruitment curves. (time frame: Baseline and at post-intervention (100 minutes)). The study lists 5 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 1 Jul 2024.