Spinal Cord InjuriesNCT05457205
Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury
A study testing Electrical neuromodulation in people with Spinal Cord Injuries and Spasticity, Muscle, run by University of Mississippi Medical Center at 2 sites in United States.
Trial summary
Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spasticity, Muscle
- What is being tested?
- Electrical neuromodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2022to 5 Apr 2025
- 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 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 SCI (ASIA Impairment Scale grades A-D)
- Time since injury longer than 6 months
- The presence of at least mild spasticity (>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity
- Signed consent form
Who cannot join
- Neurological level of SCI below T11
- Suspected progression of SCI (e.g., syringomyelia)
- Ventilatory-dependent
- Implanted active devices (e.g., intrathecal baclofen pumps)
- Passive implants (plates, screws) between T10 and L3 vertebras
- Skin conditions precluding placement of electrodes
Show all 11Show fewer
- Ongoing infections
- Pregnancy
- Difficulty following instructions
- No access to a caregiver/family member to help with electrode placement at home
- 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: Transcutaneous Spinal Stimulation for Reducing Lower Limb Spasticity in Chronic Spinal Cord Injury: a Cross-over Study of Immediate Effects and Outcomes of Home-based Therapy Trials
Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Spasticity is often disabling because it interferes with hygiene, transfers, and locomotion and can disturb sleep and cause pain. For these reasons, most individuals seek treatments for spasticity after SCI. New developments in electrical neuromodulation with transcutaneous spinal stimulation (TSS) show promising results in managing spasticity non-pharmacologically. The underlying principle of TSS interventions is that the afferent input generated by posterior root stimulation modifies the excitability of the lumbosacral network to suppress pathophysiologic spinal motor output contributing to distinctive features of spasticity. However, the previous TSS studies used almost identical protocols in terms of stimulation frequency and intensity despite the great flexibility offered by this treatment strategy and the favorable results with the epidural stimulation at higher frequencies. Therefore, the proposed study takes a new direction to systematically investigate the standalone and comparative efficacy of four TSS interventions, including those used in previous studies.
Our central hypothesis is that electrical neuromodulation with the selected TSS protocols (frequency: 50/100 Hz; intensity: 0.45 or 0.9 times the sub-motor threshold) can reduce and distinctly modify tonic and phasic components of spasticity on short- and long-term basis. We will test our hypothesis using a prospective, experimental, cross-over, assessor-masked study design in 12 individuals with chronic SCI (more than 1-year post-injury).
Read more
Aim 1. Determine the time course of changes and immediate after-effects of each TSS protocol on tonic and phasic spasticity. The results will reveal the evolution of changes in spasticity during 30-min of TSS and the most effective protocol for producing immediate aftereffects.
Aim 2. Determine the effect of TSS on spasticity after a trial of home-based therapy with each protocol. The participants will administer 30 min of TSS daily for six days with each of the four TSS protocols selected randomly. This aim will reveal the long-term carry-over effects of TSS intervention on various components of spasticity after SCI.
Aim 3. Determine the participants' experience with TSS as a home-based therapy through focus group meetings. We will conduct focus group meetings after participants finish the home-based therapy trial. Accomplishing this specific aim will provide a valuable perspective on the value, challenges, and acceptability of TSS as a home-based intervention.
The study addresses important questions for advancing scientific knowledge and clinical management of spasticity after SCI. Specifically, it will examine the efficacy of TSS frequencies and intensities on tonic and phasic spasticity. The study results will be relevant for a high proportion of individuals living with SCI that could benefit from this novel and low-cost non-pharmacological approach to managing spasticity after SCI.
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle
- Being tested
- Electrical neuromodulation
- Keywords
- Transcutaneous Spinal Cord Stimulation, Neuromodulation, Electrical Stimulation, Spasticity, Lower Extremities
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical neuromodulationOther
Also called Transcutaneous spinal stimulation, Transcutaneous spinal cord stimulation
Electrical neuromodulation intervention using transcutaneous spinal stimulation: two self-adhesive semicircle electrodes (forming a 5cm round electrode) will be centered midline over the T11-12 spinal processes, and two 8×13 cm electrodes will be placed paraumbilical and interconnected to serve as a counter electrode. A current-controlled stimulator will deliver symmetric biphasic pulses (500-μs/phase). Electrical stimulation will be applied according to the description in each study arm.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation with 50 Hz and low intensity | Experimental | Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles). Receives: Other: Electrical neuromodulation |
| Neuromodulation with 50 Hz and high intensity | Experimental | Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles). Receives: Other: Electrical neuromodulation |
| Neuromodulation with 100 Hz and low intensity | Experimental | Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles). Receives: Other: Electrical neuromodulation |
| Neuromodulation with 100 Hz and high intensity | Experimental | Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles). Receives: Other: Electrical neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posterior root reflex amplitude
The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.
Measured: Before and after an intervention session (30 minutes)
Change in posterior root reflex amplitude (during intervention)
The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.
Measured: Before and during an intervention session (15 minutes)
Change in flexion withdrawal reflex root-mean-square
The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.
Measured: Before and after an intervention session (30 minutes)
Change in flexion withdrawal reflex root-mean-square (during intervention)
The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.
Measured: Before and during an intervention session (15 minutes)
Change in pendulum test index
The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.
Measured: Before and after an intervention session (30 minutes)
Change in pendulum test index (during intervention)
The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.
Measured: Before and during an intervention session (15 minutes)
Secondary outcomes (6)
Change in Modified Ashworth Scale
The total score will be obtained by summing the individual muscle scores (value 1.5 will be used for the 1+ scoring category). The sum score ranges from 0 to 40 (0, no increase in muscle tone across all 10 tested muscles).
Measured: Before and after an intervention session (30 minutes)
Change in Modified Ashworth Scale (after one week)
The total score will be obtained by summing the individual muscle scores (value 1.5 will be used for the 1+ scoring category). The sum score ranges from 0 to 40 (0, no increase in muscle tone across all 10 tested muscles).
Measured: Before and after one week
Change in Spinal Cord Assessment Tool for Spastic Reflexes
Sum of the 4-point scale of three types of spastic behavior (ankle clonus, flexor, extensor leg spasms).
Measured: Before and after an intervention session (30 minutes)
Change in Spinal Cord Assessment Tool for Spastic Reflexes (after one week)
Sum of the 4-point scale of three types of spastic behavior (ankle clonus, flexor, extensor leg spasms).
Measured: Before and after one week
Change in Penn Spasm Frequency Scale
Sum of spasm frequency (0-5 scale) and spasm severity (0-3 scale).
Measured: Before and after an intervention session (30 minutes)
Change in Penn Spasm Frequency Scale (after one week)
Sum of spasm frequency (0-5 scale) and spasm severity (0-3 scale).
Measured: Before and after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start16 Aug 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion5 Apr 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457205
- Sponsor's protocol ID
- UMMC-IRB-2022-9
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2022
- Last updated
- 12 Apr 2024
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Stimulation for Reducing Lower Limb Spasticity in Chronic Spinal Cord Injury: a Cross-over Study of Immediate Effects and Outcomes of Home-based Therapy Trials
- ClinicalTrials.gov ID
- NCT05457205
- Acronym / sponsor ID
- UMMC-IRB-2022-9
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle
- Keywords
- Transcutaneous Spinal Cord Stimulation, Neuromodulation, Electrical Stimulation, Spasticity, Lower Extremities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Methodist Rehabilitation Center
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 13 Jul 2022 (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.
Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Spasticity is often disabling because it interferes with hygiene, transfers, and locomotion and can disturb sleep and cause pain. For these reasons, most individuals seek treatments for spasticity after SCI. New developments in electrical neuromodulation with transcutaneous spinal stimulation (TSS) show promising results in managing spasticity non-pharmacologically. The underlying principle of TSS interventions is that the afferent input generated by posterior root stimulation modifies the excitability of the lumbosacral network to suppress pathophysiologic spinal motor output contributing to distinctive features of spasticity. However, the previous TSS studies used almost identical protocols in terms of stimulation frequency and intensity despite the great flexibility offered by this treatment strategy and the favorable results with the epidural stimulation at higher frequencies. Therefore, the proposed study takes a new direction to systematically investigate the standalone and comparative efficacy of four TSS interventions, including those used in previous studies.
Our central hypothesis is that electrical neuromodulation with the selected TSS protocols (frequency: 50/100 Hz; intensity: 0.45 or 0.9 times the sub-motor threshold) can reduce and distinctly modify tonic and phasic components of spasticity on short- and long-term basis. We will test our hypothesis using a prospective, experimental, cross-over, assessor-masked study design in 12 individuals with chronic SCI (more than 1-year post-injury).
Aim 1. Determine the time course of changes and immediate after-effects of each TSS protocol on tonic and phasic spasticity. The results will reveal the evolution of changes in spasticity during 30-min of TSS and the most effective protocol for producing immediate aftereffects.
Aim 2. Determine the effect of TSS on spasticity after a trial of home-based therapy with each protocol. The participants will administer 30 min of TSS daily for six days with each of the four TSS protocols selected randomly. This aim will reveal the long-term carry-over effects of TSS intervention on various components of spasticity after SCI.
Aim 3. Determine the participants' experience with TSS as a home-based therapy through focus group meetings. We will conduct focus group meetings after participants finish the home-based therapy trial. Accomplishing this specific aim will provide a valuable perspective on the value, challenges, and acceptability of TSS as a home-based intervention.
The study addresses important questions for advancing scientific knowledge and clinical management of spasticity after SCI. Specifically, it will examine the efficacy of TSS frequencies and intensities on tonic and phasic spasticity. The study results will be relevant for a high proportion of individuals living with SCI that could benefit from this novel and low-cost non-pharmacological approach to managing spasticity after SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation with 50 Hz and low intensity | Experimental | Other: Electrical neuromodulationTranscutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles). |
| Neuromodulation with 50 Hz and high intensity | Experimental | Other: Electrical neuromodulationTranscutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles). |
| Neuromodulation with 100 Hz and low intensity | Experimental | Other: Electrical neuromodulationTranscutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles). |
| Neuromodulation with 100 Hz and high intensity | Experimental | Other: Electrical neuromodulationTranscutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles). |
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 SCI (ASIA Impairment Scale grades A-D)
- Time since injury longer than 6 months
- The presence of at least mild spasticity (>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity
- Signed consent form
Key exclusion criteria (11 listed)
- Neurological level of SCI below T11
- Suspected progression of SCI (e.g., syringomyelia)
- Ventilatory-dependent
- Implanted active devices (e.g., intrathecal baclofen pumps)
- Passive implants (plates, screws) between T10 and L3 vertebras
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 |
|---|---|---|
| Electrical neuromodulationAlso: Transcutaneous spinal stimulation, Transcutaneous spinal cord stimulationElectrical neuromodulation intervention using transcutaneous spinal stimulation: two self-adhesive semicircle electrodes (forming a 5cm round electrode) will be centered midline over the T11-12 spinal processes, and two 8×13 cm electrodes will be placed paraumbilical and interconnected to serve as a counter electrode. A current-controlled stimulator will deliver symmetric biphasic pulses (500-μs/phase). Electrical stimulation will be applied according to the description in each study arm. | Other | Neuromodulation with 100 Hz and high intensity, Neuromodulation with 100 Hz and low intensity, Neuromodulation with 50 Hz and high intensity, Neuromodulation with 50 Hz and low intensity |
Primary outcome
Change in posterior root reflex amplitude
Time frame: Before and after an intervention session (30 minutes)
The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.
Change in posterior root reflex amplitude (during intervention)
Time frame: Before and during an intervention session (15 minutes)
The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.
Change in flexion withdrawal reflex root-mean-square
Time frame: Before and after an intervention session (30 minutes)
The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.
Change in flexion withdrawal reflex root-mean-square (during intervention)
Time frame: Before and during an intervention session (15 minutes)
The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.
Change in pendulum test index
Time frame: Before and after an intervention session (30 minutes)
The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.
Change in pendulum test index (during intervention)
Time frame: Before and during an intervention session (15 minutes)
The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.
6 secondary outcomes
Change in Modified Ashworth Scale
Time frame: Before and after an intervention session (30 minutes)
Change in Modified Ashworth Scale (after one week)
Time frame: Before and after one week
Change in Spinal Cord Assessment Tool for Spastic Reflexes
Time frame: Before and after an intervention session (30 minutes)
Change in Spinal Cord Assessment Tool for Spastic Reflexes (after one week)
Time frame: Before and after one week
Change in Penn Spasm Frequency Scale
Time frame: Before and after an intervention session (30 minutes)
Change in Penn Spasm Frequency Scale (after one week)
Time frame: Before and after one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Project information - Methodist Rehabilitation CenterLink provided by the sponsor.
- 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, PhD 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 Electrical neuromodulation in people with Spinal Cord Injuries and Spasticity, Muscle, 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 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: status not confirmed, as of the sponsor's last update on 12 Apr 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.
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, PhD (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 in posterior root reflex amplitude (time frame: Before and after an intervention session (30 minutes)). The study lists 6 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 12 Apr 2024.