Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

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

Timeline

Start

2024-12

Primary completion

2028-12

Completion

2029-06

Publications

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

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