Traumatic Spinal Cord InjuryPhase 4NCT06564714
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
A Phase 4 study testing Early baclofen Intervention and Usual routine care in people with Traumatic Spinal Cord Injury, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI. The main questions it aims to answer are : 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Spinal Cord Injury
- What is being tested?
- Early baclofen Intervention and Usual routine care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2024to Jun 2029
- Phase
- Phase 4
- 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
- Male or female aged 18 years or older
- Blunt (non-penetrating) traumatic SCI
- AIS grade A to D
- NLI between C0 and L1
- Patient willing and able to provide informed consent
Who cannot join
- Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)
- AIS grade E upon admission
- Penetrating tSCI (from stab wound, gunshot injury, etc.)
- Cauda equina syndrome or NLI below L1
- Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)
- Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant)
Show all 10Show fewer
- Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.)
- Major cognitive deficits precluding informed consent and/or assessments
- Unlikely to comply with scheduled visits (e.g. living in another country)
- Renal insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
About this study
Official title: Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery: a Randomized Clinical Trial
The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.
The main questions it aims to answer are :
Read more
- Assess the safety of early baclofen treatment during acute care after SCI.
- Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.
Read the detailed description
Spasticity is a condition in which muscles are abnormally stiff or tight, and interfere with normal movement. Following spinal cord injury (SCI), spasticity is common, affecting up to 70% of patients in the chronic stage 6 months or more after the injury. (1-4). After SCI, spasticity is due to a stretch reflex disorder of sensorimotor control following an upper motor neuron lesion, i.e. a lesion involving the neurons carrying the information within the spinal cord. Clinically, spasticity manifests as a complex syndrome of velocity-dependent hypertonia, clonus (rhythmic oscillating stretch reflex) and spasms (involuntary muscle contractions) that can have profound consequences on function and quality of life.
Traditionally, the clinical impact of spasticity has been mostly recognized during the subacute and chronic phases after SCI. Based upon the current management paradigm, the great majority of individuals with spasticity will receive pharmaceutical treatment for spasticity only during the rehabilitation period weeks or months after the injury when the clinical manifestations become severe and problematic. The investigators have challenged this long-held belief by proposing their paradigm shift towards early recognition and treatment of spasticity during the acute within the first month after SCI, after showing that about half of individuals will develop clinical signs of early spasticity during the acute hospitalization, and that acute spasticity is associated with poor long-term outcomes.
In particular, the investigators found that long-term mobility is significantly decreased in individuals presenting acute spasticity within the first month after the SCI. Our preliminary data suggest that prompt pharmacological treatment with baclofen - an anti-spasmodic medication - during the acute hospitalization improves neurological recovery in the presence of acute spasticity. Based on these preliminary findings, the overarching hypothesis of this study is that long-term neurofunctional outcomes are improved by early detection of acute spasticity and immediate treatment with oral baclofen.
Our team of experienced clinician-scientists specialized in SCI care therefore propose a single-site pilot randomized clinical trial including 55 patients admitted for a traumatic SCI (tSCI), in order to evaluate the safety and neurofunctional benefits of early baclofen treatment (i.e. as soon as any signs of spasticity are observed within the first month after the injury) during the acute hospitalization.
- Conditions
- Traumatic Spinal Cord Injury
- Being tested
- Early baclofen Intervention, Usual routine care
- Keywords
- Trauma, Spinal Cord Injury, Baclofen, Spasticity
- Medical subject headings
- Wounds and Injuries, Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early baclofen InterventionDrug
Baclofen is initiated as soon as any sign of acute spasticity.
5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic.
Usual routine careDrug
Baclofen is initiated only when acute spasticity is deemed problematic.
5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.
| Study group | Role | What they receive |
|---|---|---|
| Early Baclofen treatment group | Experimental | Oral baclofen will be started as soon as any sign of acute spasticity consisting of spasms, velocity-dependent hypertonia and/or clonus is observed. Oral baclofen will be initiated the same day as when signs of spasticity are first observed.
Dosage : oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, Receives: Drug: Early baclofen Intervention |
| Control group | Other | The control group will receive the "usual routine care" as per which baclofen is prescribed only when acute spasticity becomes severe and problematic.
In the presence of problematic spasticity, oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response. Receives: Drug: Usual routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Independence Measure (SCIM)
The primary outcome consists of the mobility subscore from the SCIM 6 months after the SCI with early baclofen treatment when compared to the control group.
The SCIM will measure the ability of the 55 SCI patients to perform basic activities of daily living independently. There are 19 items divided into 3 subscales.
A total score out of 100 is achieved, with the subscales weighted as follows:
- self-care: scored 0-20;
- respiration and sphincter management: scored 0-40; and
- mobility: scored 0-40
Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Measured: 6 months after the injury
Adverse Events
Adverse events will be collected for both early baclofen treatment and control groups during acute care after SCI.
Measured: From acute care to 6 months after the injury,
Secondary outcomes (7)
Spastic reflexe assessment
The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) will be used to measure spastic reflexes. This will be measured weekly, after hospital discharge and during outpatient follow-up visits 6 weeks and 6 months after the injury.
The SCATS is split into 3 subscales, each addressing a seperate spasm.
- Clonus 2) Flexor spasms 3) Extensor spasms.
For each subscale, the spasm is triggered and then rated. The degree of spasm is rated between 0 (no spasm) to 3 (severe spasm lasting longer than 10 seconds)
Measured: All data on spastic reflexes will be collected from acute care to 6 months after the injury
Muscle Spasticity assessment
The Modified Ashworth Scale (MAS) will be used to measure spasticity for each muscle assessed.
The MAS is a 6-point scale. Scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). This scale also adds a +1 scoring category to indicate resistance through less than half of the movement.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Measured: All treatment and data on spasticity will be collected from acute care to 6 months after the injury.
Spasticity frequency
The Modified Penn Spasm Frequency Scale (mPSFS) will be used to quantify spasticity.
It is a 2 component self-report measure in which the patients will report their perception of spasticity in regards to frequency and severity.
The first component is a 5 point scale assessing the frequency with which spasms occur ranging from 0 (No spasms) to 4 (Spontaneous spasms occurring more than ten times per hour)
The second component is a 3 point scale assessing the severity of spasms ranging from 1 (Mild) to 3 (Severe).
The second component is not answered if the person indicates they have no spasms in part 1.
Measured: All data on the frequency of spasticity will be collected from acute care to 6 months after the injury
Spasticity impact
The Patient Reported Impact of Spasticity Measure (PRISM) measures the impact of SCI-related spasticity on quality of life from the patient's perspective.
The PRISM consists of 41 items, divided into 7 subscales namely anxiety, psychological agitation, daily activities, assistance, positive impact, need for intervention, social embarrassment.
It uses 5 point Likert Scale for scoring, 0 = Never true for me, 1 = Rarely true for me, 3 = Often true for me, 4 = Very often true for me. A higher score is considered unhealthy.
Measured: All data on the impact of spasticity will be collected from acute care to 6 months after the injury
Neurological Assessment
The neurological status assessed from repeated neurological examinations between baseline and 6 months post-SCI will be measured using the International Standards for Neurological Classification of SCI (ISNCSCI)
This impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury (i.e. whether the injury is complete or incomplete).
Sensory evaluation is completed using a three-point scale for scoring. 0 = absent, 1 = altered (impaired or partial appreciation, including hyperesthesia), 2 = normal or intact (similar as on the cheek), NT = not testable.
Motor evaluation is completed using a six-point scale for scoring ranging from 0 (total paralysis) to 5 (normal) active movement, full range of motion against gravity and full resistance in a muscle specific position expected from an otherwise unimpaired person)
Measured: From acute care to 6 months after the injury,
Functional Assessment and Independent Walking
The 3rd version of the Spinal Cord Independence Measure (SCIM) will be used to report the ability of SCI patients to perform daily living activities independently,
This questionnaire will measure Functional outcome of SCI partients before acute care and inpatient rehabilitation discharge, and at each follow-up visit.
Measured: From acute care to 6 months after the injury,
Pain Assessment
Pain assessment will be measured using the International Spinal Cord Injury Pain Basic Data Set (version 2.0).
Information concerning pain's interference with physical and emotional function and sleep, probable pain diagnosis, pain location, pain intensity, and duration will be collected.
Measured: From acute care to 6 months after the injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Traumatic Spinal Cord InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 55 recruited participants will be randomized into the early baclofen treatment group or the control group.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréane Richard-Denis, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Andréane Richard-Denis, M.D., MSC, Principal investigator, CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564714
- Sponsor's protocol ID
- MP-32-2023-2550
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cragg JJ, Tong B, Jutzeler CR, Warner FM, Cashman N, Geisler F, Kramer JLK. A Longitudinal Study of the Neurologic Safety of Acute Baclofen Use After Spinal Cord Injury. Neurotherapeutics. 2019 Jul;16(3):858-867. doi: 10.1007/s13311-019-00713-8.
PubMed 30725362Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
PubMed 15799140Adams MM, Hicks AL. Spasticity after spinal cord injury. Spinal Cord. 2005 Oct;43(10):577-86. doi: 10.1038/sj.sc.3101757.
PubMed 15838527Holtz KA, Lipson R, Noonan VK, Kwon BK, Mills PB. Prevalence and Effect of Problematic Spasticity After Traumatic Spinal Cord Injury. Arch Phys Med Rehabil. 2017 Jun;98(6):1132-1138. doi: 10.1016/j.apmr.2016.09.124. Epub 2016 Oct 22.
PubMed 27780743Ahuja CS, Wilson JR, Nori S, Kotter MRN, Druschel C, Curt A, Fehlings MG. Traumatic spinal cord injury. Nat Rev Dis Primers. 2017 Apr 27;3:17018. doi: 10.1038/nrdp.2017.18.
PubMed 28447605Ayoub S, Smith JG, Cary I, Dalton C, Pinto A, Ward C, Saverino A. The positive and the negative impacts of spasticity in patients with long-term neurological conditions: an observational study. Disabil Rehabil. 2021 Nov;43(23):3357-3364. doi: 10.1080/09638288.2020.1742803. Epub 2020 Mar 30.
PubMed 32223455Ehrmann C, Mahmoudi SM, Prodinger B, Kiekens C, Ertzgaard P. Impact of spasticity on functioning in spinal cord injury: an application of graphical modelling. J Rehabil Med. 2020 Mar 31;52(3):jrm00037. doi: 10.2340/16501977-2657.
PubMed 32103278D'Amico JM, Condliffe EG, Martins KJ, Bennett DJ, Gorassini MA. Recovery of neuronal and network excitability after spinal cord injury and implications for spasticity. Front Integr Neurosci. 2014 May 12;8:36. doi: 10.3389/fnint.2014.00036. eCollection 2014.
PubMed 24860447Bhimani RH, Anderson LC, Henly SJ, Stoddard SA. Clinical measurement of limb spasticity in adults: state of the science. J Neurosci Nurs. 2011 Apr;43(2):104-15. doi: 10.1097/jnn.0b013e31820b5f9f.
PubMed 21488584Adams MM, Ginis KA, Hicks AL. The spinal cord injury spasticity evaluation tool: development and evaluation. Arch Phys Med Rehabil. 2007 Sep;88(9):1185-92. doi: 10.1016/j.apmr.2007.06.012.
PubMed 17826466Lechner HE, Frotzler A, Eser P. Relationship between self- and clinically rated spasticity in spinal cord injury. Arch Phys Med Rehabil. 2006 Jan;87(1):15-9. doi: 10.1016/j.apmr.2005.07.312.
PubMed 16401432Levasseur A, Mac-Thiong JM, Richard-Denis A. Are early clinical manifestations of spasticity associated with long-term functional outcome following spinal cord injury? A retrospective study. Spinal Cord. 2021 Aug;59(8):910-916. doi: 10.1038/s41393-021-00661-1. Epub 2021 Jul 6.
PubMed 34230603Hiersemenzel LP, Curt A, Dietz V. From spinal shock to spasticity: neuronal adaptations to a spinal cord injury. Neurology. 2000 Apr 25;54(8):1574-82. doi: 10.1212/wnl.54.8.1574.
PubMed 10762496Dietz V, Sinkjaer T. Spastic movement disorder: impaired reflex function and altered muscle mechanics. Lancet Neurol. 2007 Aug;6(8):725-33. doi: 10.1016/S1474-4422(07)70193-X.
PubMed 17638613Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
PubMed 33978513
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06564714
- Acronym / sponsor ID
- MP-32-2023-2550
- Conditions
- Traumatic Spinal Cord Injury
- Keywords
- Trauma, Spinal Cord Injury, Baclofen, Spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Aug 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.
The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.
The main questions it aims to answer are :
- Assess the safety of early baclofen treatment during acute care after SCI.
- Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.
Detailed description
Spasticity is a condition in which muscles are abnormally stiff or tight, and interfere with normal movement. Following spinal cord injury (SCI), spasticity is common, affecting up to 70% of patients in the chronic stage 6 months or more after the injury. (1-4). After SCI, spasticity is due to a stretch reflex disorder of sensorimotor control following an upper motor neuron lesion, i.e. a lesion involving the neurons carrying the information within the spinal cord. Clinically, spasticity manifests as a complex syndrome of velocity-dependent hypertonia, clonus (rhythmic oscillating stretch reflex) and spasms (involuntary muscle contractions) that can have profound consequences on function and quality of life.
Traditionally, the clinical impact of spasticity has been mostly recognized during the subacute and chronic phases after SCI. Based upon the current management paradigm, the great majority of individuals with spasticity will receive pharmaceutical treatment for spasticity only during the rehabilitation period weeks or months after the injury when the clinical manifestations become severe and problematic. The investigators have challenged this long-held belief by proposing their paradigm shift towards early recognition and treatment of spasticity during the acute within the first month after SCI, after showing that about half of individuals will develop clinical signs of early spasticity during the acute hospitalization, and that acute spasticity is associated with poor long-term outcomes.
In particular, the investigators found that long-term mobility is significantly decreased in individuals presenting acute spasticity within the first month after the SCI. Our preliminary data suggest that prompt pharmacological treatment with baclofen - an anti-spasmodic medication - during the acute hospitalization improves neurological recovery in the presence of acute spasticity. Based on these preliminary findings, the overarching hypothesis of this study is that long-term neurofunctional outcomes are improved by early detection of acute spasticity and immediate treatment with oral baclofen.
Our team of experienced clinician-scientists specialized in SCI care therefore propose a single-site pilot randomized clinical trial including 55 patients admitted for a traumatic SCI (tSCI), in order to evaluate the safety and neurofunctional benefits of early baclofen treatment (i.e. as soon as any signs of spasticity are observed within the first month after the injury) during the acute hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 55 recruited participants will be randomized into the early baclofen treatment group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Early Baclofen treatment group | Experimental | Drug: Early baclofen InterventionOral baclofen will be started as soon as any sign of acute spasticity consisting of spasms, velocity-dependent hypertonia and/or clonus is observed. Oral baclofen will be initiated the same day as when signs of spasticity are first observed. Dosage : oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, |
| Control group | Other | Drug: Usual routine careThe control group will receive the "usual routine care" as per which baclofen is prescribed only when acute spasticity becomes severe and problematic. In the presence of problematic spasticity, oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 years or older
- Blunt (non-penetrating) traumatic SCI
- AIS grade A to D
- NLI between C0 and L1
- Patient willing and able to provide informed consent
Key exclusion criteria (10 listed)
- Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)
- AIS grade E upon admission
- Penetrating tSCI (from stab wound, gunshot injury, etc.)
- Cauda equina syndrome or NLI below L1
- Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)
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 |
|---|---|---|
| Early baclofen InterventionBaclofen is initiated as soon as any sign of acute spasticity. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. | Drug | Early Baclofen treatment group |
| Usual routine careBaclofen is initiated only when acute spasticity is deemed problematic. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response. | Drug | Control group |
Primary outcome
Spinal Cord Independence Measure (SCIM)
Time frame: 6 months after the injury
The primary outcome consists of the mobility subscore from the SCIM 6 months after the SCI with early baclofen treatment when compared to the control group. The SCIM will measure the ability of the 55 SCI patients to perform basic activities of daily living independently. There are 19 items divided into 3 subscales. A total score out of 100 is achieved, with the subscales weighted as follows: 1. self-care: scored 0-20; 2. respiration and sphincter management: scored 0-40; and 3. mobility: scored 0-40 Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Adverse Events
Time frame: From acute care to 6 months after the injury,
Adverse events will be collected for both early baclofen treatment and control groups during acute care after SCI.
7 secondary outcomes
Spastic reflexe assessment
Time frame: All data on spastic reflexes will be collected from acute care to 6 months after the injury
Muscle Spasticity assessment
Time frame: All treatment and data on spasticity will be collected from acute care to 6 months after the injury.
Spasticity frequency
Time frame: All data on the frequency of spasticity will be collected from acute care to 6 months after the injury
Spasticity impact
Time frame: All data on the impact of spasticity will be collected from acute care to 6 months after the injury
Neurological Assessment
Time frame: From acute care to 6 months after the injury,
Functional Assessment and Independent Walking
Time frame: From acute care to 6 months after the injury,
Pain Assessment
Time frame: From acute care to 6 months after the injury
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 21 Aug 2024.
- Background: PubMed 30725362Cragg JJ, Tong B, Jutzeler CR, Warner FM, Cashman N, Geisler F, Kramer JLK. A Longitudinal Study of the Neurologic Safety of Acute Baclofen Use After Spinal Cord Injury. Neurotherapeutics. 2019 Jul;16(3):858-867. doi: 10.1007/s13311-019-00713-8.
- Background: PubMed 15799140Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
- Background: PubMed 15838527Adams MM, Hicks AL. Spasticity after spinal cord injury. Spinal Cord. 2005 Oct;43(10):577-86. doi: 10.1038/sj.sc.3101757.
- Background: PubMed 27780743Holtz KA, Lipson R, Noonan VK, Kwon BK, Mills PB. Prevalence and Effect of Problematic Spasticity After Traumatic Spinal Cord Injury. Arch Phys Med Rehabil. 2017 Jun;98(6):1132-1138. doi: 10.1016/j.apmr.2016.09.124. Epub 2016 Oct 22.
- Background: PubMed 28447605Ahuja CS, Wilson JR, Nori S, Kotter MRN, Druschel C, Curt A, Fehlings MG. Traumatic spinal cord injury. Nat Rev Dis Primers. 2017 Apr 27;3:17018. doi: 10.1038/nrdp.2017.18.
- Background: PubMed 32223455Ayoub S, Smith JG, Cary I, Dalton C, Pinto A, Ward C, Saverino A. The positive and the negative impacts of spasticity in patients with long-term neurological conditions: an observational study. Disabil Rehabil. 2021 Nov;43(23):3357-3364. doi: 10.1080/09638288.2020.1742803. Epub 2020 Mar 30.
- Background: PubMed 32103278Ehrmann C, Mahmoudi SM, Prodinger B, Kiekens C, Ertzgaard P. Impact of spasticity on functioning in spinal cord injury: an application of graphical modelling. J Rehabil Med. 2020 Mar 31;52(3):jrm00037. doi: 10.2340/16501977-2657.
- Background: PubMed 24860447D'Amico JM, Condliffe EG, Martins KJ, Bennett DJ, Gorassini MA. Recovery of neuronal and network excitability after spinal cord injury and implications for spasticity. Front Integr Neurosci. 2014 May 12;8:36. doi: 10.3389/fnint.2014.00036. eCollection 2014.
- Background: PubMed 21488584Bhimani RH, Anderson LC, Henly SJ, Stoddard SA. Clinical measurement of limb spasticity in adults: state of the science. J Neurosci Nurs. 2011 Apr;43(2):104-15. doi: 10.1097/jnn.0b013e31820b5f9f.
- Background: PubMed 17826466Adams MM, Ginis KA, Hicks AL. The spinal cord injury spasticity evaluation tool: development and evaluation. Arch Phys Med Rehabil. 2007 Sep;88(9):1185-92. doi: 10.1016/j.apmr.2007.06.012.
- Background: PubMed 16401432Lechner HE, Frotzler A, Eser P. Relationship between self- and clinically rated spasticity in spinal cord injury. Arch Phys Med Rehabil. 2006 Jan;87(1):15-9. doi: 10.1016/j.apmr.2005.07.312.
- Background: PubMed 34230603Levasseur A, Mac-Thiong JM, Richard-Denis A. Are early clinical manifestations of spasticity associated with long-term functional outcome following spinal cord injury? A retrospective study. Spinal Cord. 2021 Aug;59(8):910-916. doi: 10.1038/s41393-021-00661-1. Epub 2021 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Andréane Richard-Denis, M.D., MSC principal investigator
CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early baclofen Intervention and Usual routine care in people with Traumatic Spinal Cord Injury, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 10 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: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lara Chawa (514-338-2222 ext. 5833276, lara.chawa.cnmtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Independence Measure (SCIM) (time frame: 6 months after the injury). 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?
On the ClinicalTrials.gov record for NCT06564714, which also lists 15 linked publications.
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 21 Aug 2024.