Trial · NCT06564714
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
NCT06564714, Phase 4, Not yet recruiting, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury. Trials, record NCT06564714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06564714
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
- NCT number
- NCT06564714
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 55 participants, estimated
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Conditions
- Traumatic Spinal Cord Injury
- Interventions
- Early baclofen Intervention, Usual routine care
- First posted
- 2024-08-21
- Last updated
- 2024-08-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spinal Cord Independence Measure (SCIM) | 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. |
| Primary | Adverse Events | 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. |
| Secondary | Spastic reflexe assessment | All data on spastic reflexes will be collected from acute care to 6 months after the injury | 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) |
| Secondary | Muscle Spasticity assessment | All treatment and data on spasticity will be collected from acute care to 6 months after the injury. | 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. |
| Secondary | Spasticity frequency | All data on the frequency of spasticity will be collected from acute care to 6 months after the injury | 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. |
| Secondary | Spasticity impact | All data on the impact of spasticity will be collected from acute care to 6 months after the injury | 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. |
| Secondary | Neurological Assessment | From acute care to 6 months after the injury, | 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) |
| Secondary | Functional Assessment and Independent Walking | From acute care to 6 months after the injury, | 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. |
| Secondary | Pain Assessment | From acute care to 6 months after the injury | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06564714
GET https://conductscience.org/api/trials/v1/NCT06564714/registered