Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
NCT Number: NCT06564714
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Traumatic Spinal Cord Injury
Interventions: DRUG: Early baclofen Intervention|DRUG: Usual routine care
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2029-06
Locations: CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal, Montréal, Quebec, H4J 1C5, Canada

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.

Primary Outcome Measures: 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 Outcome Measures: 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.

1) 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), 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., 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., 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., 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), 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., 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., From acute care to 6 months after the injury