Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

NCT06564714 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: MP-32-2023-2550
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 1.Assess the safety of early baclofen treatment during acute care after SCI.
2. 2.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.

Conditions

Traumatic Spinal Cord Injury

Keywords

Trauma; Spinal Cord Injury; Baclofen; Spasticity

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  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.

  From acute care to 6 months after the injury,

Secondary Outcomes (7)

• Spastic reflexe assessment

  All data on spastic reflexes will be collected from acute care to 6 months after the injury

• Muscle Spasticity assessment

  All treatment and data on spasticity will be collected from acute care to 6 months after the injury.

• Spasticity frequency

  All data on the frequency of spasticity will be collected from acute care to 6 months after the injury

• Spasticity impact

  All data on the impact of spasticity will be collected from acute care to 6 months after the injury

• Neurological Assessment

  From acute care to 6 months after the injury,

Study Arms (2)

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,

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.

Drug: Usual routine care

Interventions

Early baclofen Intervention DRUG

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.

Early Baclofen treatment group

Usual routine care DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant)
• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (15)

• 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.

  PMID: 30725362 BACKGROUND

• Pandyan 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.

  PMID: 15799140 BACKGROUND

• Adams MM, Hicks AL. Spasticity after spinal cord injury. Spinal Cord. 2005 Oct;43(10):577-86. doi: 10.1038/sj.sc.3101757.

  PMID: 15838527 BACKGROUND

• Holtz 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.

  PMID: 27780743 BACKGROUND

• Ahuja 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.

  PMID: 28447605 BACKGROUND

• Ayoub 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.

  PMID: 32223455 BACKGROUND

• Ehrmann 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.

  PMID: 32103278 BACKGROUND

• D'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.

  PMID: 24860447 BACKGROUND

• Bhimani 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.

  PMID: 21488584 BACKGROUND

• Adams 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.

  PMID: 17826466 BACKGROUND

• Lechner 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.

  PMID: 16401432 BACKGROUND

• Levasseur 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.

  PMID: 34230603 BACKGROUND

• Hiersemenzel 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.

  PMID: 10762496 BACKGROUND

• Dietz 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.

  PMID: 17638613 BACKGROUND

• Li 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.

  PMID: 33978513 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andréane Richard-Denis, M.D., MSC

  CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Chawa

CONTACT

514-338-2222; lara.chawa.cnmtl@ssss.gouv.qc.ca

Pascal Mputu

CONTACT

514-338-2222; pascal.mputu.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both investigators and trial participants will be fully aware of which treatment group the participants are in and what treatments are assigned to them. Participants will be randomized into the early baclofen treatment or control group using computer-generated random treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 55 recruited participants will be randomized into the early baclofen treatment group or the control group.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: August 21, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)