SpasticityNCT05422716
"Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
A study testing Epidural implant stimulation device in people with Spasticity, run by Kessler Foundation.
Trial summary
This study aims to expand the knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Epidural implant stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2022to 15 May 2026
- 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
- I must be at least 18 years of age
- I must have a non-progressive spinal cord injury (SCI)
- I have met the clinical criteria for an intrathecal baclofen pump
- I am in stable medical condition
Who cannot join
- I must not be ventilator dependent
- I must not have untreated painful musculoskeletal dysfunction, fracture or pressure injury
- I must not have untreated psychiatric disorder or ongoing drug abuse, as determined by study staff
- I must not have cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
- I must not have had peripheral muscle Botox injections less than 12 months prior to implant
- I must not have a colostomy bag or urostomy
Show all 9Show fewer
- I must not have any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
- I must not be pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- I must not have an active implantable device that may interfere with the epidural neurostimulator
About this study
This study aims to expand the knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI). The purpose of this study is to compare if spinal cord epidural stimulation can treat severe spasticity more effectively and have fewer side effects than a baclofen pump.
Read the detailed description
This study aims to expand our knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI) who are not adequately treated with oral pharmacological management, while avoiding side effects, and also improving voluntary control using surgically implantable targeted tonic spinal cord epidural stimulation (scES) . Individuals recruited and enrolled in the study will have significant spasticity not adequately treated by oral medications and clinically referred for an intrathecal baclofen pump trial. Current treatment of severe spasticity by pharmacological treatments are associated with several concomitant side effects that have consequences including limiting the ability to participate in and respond to neurorehabilitation15 and diminishing quality of life. Also, for persons with SCI and severe spasticity, available rehabilitation therapies are limited in their ability to foster appropriate neural excitation and subsequently motor recovery.
This study focuses on ameliorating severe spasticity through specific spasticity-targeted spinal cord epidural stimulation (SP-scES) that has been shown to mediate levels of neural excitation for movement and unwanted muscle activation. The study will be evaluated as compared to a standard of care control group using pharmacological administration via an intrathecal baclofen pump (ITBP). In the long-term, this study will also provide a framework to develop clinically viable approaches with tools to provide optimized care for individuals with chronic SCI. This research is directly aimed to improve the quality of life for those affected by and living with SCI by reducing spasticity (and increasing voluntary control of movement) in the home and community while avoiding debilitating side effects of long-term pharmacological intervention.
- Conditions
- Spasticity
- Being tested
- Epidural implant stimulation device
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural implant stimulation deviceDevice
Also called Baclofen Pump device
Individuals randomized to the Baclofen pump device group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The epidural implant group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.
| Study group | Role | What they receive |
|---|---|---|
| Surgically implanted epidural stimulation for spasticity | Experimental | The epidural stimulation (ES) group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity. In each subsequent 6 months we will enroll cohorts of (n=5) voluntary research participants to allow for the final cohort to complete their 6 month follow up with a remaining 3 months for final data analyses and dissemination for the grant period.
Spinal cord epidural stimulation is administered by a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord. Receives: Device: Epidural implant stimulation device |
| Surgically implanted Intrathecal baclofen pump, the standard of care control group | Experimental | Individuals randomized to the baclofen pump (BP) group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments).
The Baclofen pump will be surgically implanted by a member of the clinical SCI medical team. Receives: Device: Epidural implant stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity
Three common triggers of spasticity for each person will be identified, such as quick stretch of the ankle, flexion/extension of the hip, and rapid position changes. Each trigger will be implemented consecutively three times while recording EMG from the hip, knee, and ankle muscles bilaterally. Integrated EMG will assess the total EMG activity generated in response to the spasticity trigger for each muscle for each attempt. Muscles: (SOL), medial gastrocnemius (MG), tibialis anterior (TA), medial hamstrings (MH), quadriceps (VL and RF), adductor (AD) and/or other related muscles.
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Secondary outcomes (6)
The Penn Spasm Scale
The Penn Spasm Scale is a self-report noting both the severity and frequency of spasms
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Modified Ashworth Score
Modified Ashworth Score assesses on a scale of 0 to 4 the resistance of a relaxed, single joint as it is moved throughout its full available range of motion. Participants will be instructed to relax and to allow the examiner to perform the test movements
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Frequency of Side Effects
The side effects including fatigue, drowsiness, dizziness, weakness, confusion, headache, nausea, and sexual dysfunction will be recorded using temporaneous recording of each effect and its duration with STIMX PICS algorithms.
STIMX PICS recordings (subjective spasticity measures and frequency of side effects) will occur for 24 hours twice prior to implantation and weekly after surgery throughout the 3 months of intervention.
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement
Hip and knee extension and flexion and ankle dorsi and plantar flexion will be attempted consecutively three times in response to a 3 tone while recording EMG from the hip, knee, and ankle muscles bilaterally.
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
NeuroRecovery Scale (NRS) for Lower Body and Trunk
The NRS is a valid, reliable, and responsive evaluation tool for measuring functional recovery in persons with SCI based on tasks that test pre-injury functional capability.
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
The AIS Impairment Scale
The ASIA Impairment Scale (AIS) is a classification in SCI that describes the level and severity of the injury, based upon the motor and sensory examination as described in the International Standards of Neurological Classification for SCI (ISNCSCI)
Measured: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start14 Jul 2022 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- participants will be randomized into either the baclofen group or epidural stimulation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422716
- Sponsor's protocol ID
- R-1176-22
- Status last verified
- Jun 2022
- First submitted
- 5 May 2022
- Last updated
- 16 Jun 2022
- 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 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
- ClinicalTrials.gov ID
- NCT05422716
- Acronym / sponsor ID
- R-1176-22
- Conditions
- Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 14 Jul 2022 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 16 Jun 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.
This study aims to expand the knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI). The purpose of this study is to compare if spinal cord epidural stimulation can treat severe spasticity more effectively and have fewer side effects than a baclofen pump.
Detailed description
This study aims to expand our knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI) who are not adequately treated with oral pharmacological management, while avoiding side effects, and also improving voluntary control using surgically implantable targeted tonic spinal cord epidural stimulation (scES) . Individuals recruited and enrolled in the study will have significant spasticity not adequately treated by oral medications and clinically referred for an intrathecal baclofen pump trial. Current treatment of severe spasticity by pharmacological treatments are associated with several concomitant side effects that have consequences including limiting the ability to participate in and respond to neurorehabilitation15 and diminishing quality of life. Also, for persons with SCI and severe spasticity, available rehabilitation therapies are limited in their ability to foster appropriate neural excitation and subsequently motor recovery.
This study focuses on ameliorating severe spasticity through specific spasticity-targeted spinal cord epidural stimulation (SP-scES) that has been shown to mediate levels of neural excitation for movement and unwanted muscle activation. The study will be evaluated as compared to a standard of care control group using pharmacological administration via an intrathecal baclofen pump (ITBP). In the long-term, this study will also provide a framework to develop clinically viable approaches with tools to provide optimized care for individuals with chronic SCI. This research is directly aimed to improve the quality of life for those affected by and living with SCI by reducing spasticity (and increasing voluntary control of movement) in the home and community while avoiding debilitating side effects of long-term pharmacological intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants will be randomized into either the baclofen group or epidural stimulation
| Arm | Type | Receives |
|---|---|---|
| Surgically implanted epidural stimulation for spasticity | Experimental | Device: Epidural implant stimulation deviceThe epidural stimulation (ES) group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity. In each subsequent 6 months we will enroll cohorts of (n=5) voluntary research participants to allow for the final cohort to complete their 6 month follow up with a remaining 3 months for final data analyses and dissemination for the grant period. Spinal cord epidural stimulation is administered by a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord. |
| Surgically implanted Intrathecal baclofen pump, the standard of care control group | Experimental | Device: Epidural implant stimulation deviceIndividuals randomized to the baclofen pump (BP) group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The Baclofen pump will be surgically implanted by a member of the clinical SCI medical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- I must be at least 18 years of age
- I must have a non-progressive spinal cord injury (SCI)
- I have met the clinical criteria for an intrathecal baclofen pump
- I am in stable medical condition
Key exclusion criteria (9 listed)
- I must not be ventilator dependent
- I must not have untreated painful musculoskeletal dysfunction, fracture or pressure injury
- I must not have untreated psychiatric disorder or ongoing drug abuse, as determined by study staff
- I must not have cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
- I must not have had peripheral muscle Botox injections less than 12 months prior to implant
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 |
|---|---|---|
| Epidural implant stimulation deviceAlso: Baclofen Pump deviceIndividuals randomized to the Baclofen pump device group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The epidural implant group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity. | Device | Surgically implanted Intrathecal baclofen pump, the standard of care control group, Surgically implanted epidural stimulation for spasticity |
Primary outcome
Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Three common triggers of spasticity for each person will be identified, such as quick stretch of the ankle, flexion/extension of the hip, and rapid position changes. Each trigger will be implemented consecutively three times while recording EMG from the hip, knee, and ankle muscles bilaterally. Integrated EMG will assess the total EMG activity generated in response to the spasticity trigger for each muscle for each attempt. Muscles: (SOL), medial gastrocnemius (MG), tibialis anterior (TA), medial hamstrings (MH), quadriceps (VL and RF), adductor (AD) and/or other related muscles.
6 secondary outcomes
The Penn Spasm Scale
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Modified Ashworth Score
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Frequency of Side Effects
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
NeuroRecovery Scale (NRS) for Lower Body and Trunk
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
The AIS Impairment Scale
Time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural implant stimulation device in people with Spasticity, run by Kessler Foundation.
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 4 inclusion and 9 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity (time frame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)). 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 16 Jun 2022; AzTrials last refreshed its copy on 3 Nov 2026.