Ireland
--:--IST
Recruiting Not applicable

Neural Plasticity and Motor Recovery After Upper Extremity Motor Training in People With c-SCI

NCT06065384 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Annemie Spooren
Phase
Not applicable
Started
2024-10-09
Last updated
2025-12-12

Condition(s) studied

Spinal Cord Injuries

Investigational drug(s) / intervention(s)

experimental group: intensive motor trainingusual care

experimental group: intensive motor training: Intervention group: receive an extra 6 hours of motor training each week (distributed over the week) for 8 weeks. It will involve active and targeted motor training of all affected muscles of the upper limb below the level of the injury within the context of practice of functional activities. Interventions will be goal directed and individualized to the needs of each participant with a focus on training that addresses each person's specific motor problem, promoting motor learning as well as stimulating neural plasticity. All patients will continue to receive usual physiotherapy and usual rehabilitation.

usual care: usual rehabilitation

Study summary

After spinal cord injury (SCI), there is a disruption in neural circuits resulting in paralysis. There is not yet a cure for paralysis. In persons with Cervical SCI (pwC-SCI) recovery of arm-hand function is very important as it has a significant impact on the patients' level of independence and quality of life. Recovery is assumed to involve alterations in both central and peripheral motor systems. Motor training at an intensive dosage potentially provides a powerful stimulus for neurological recovery. This project exploits the peripheral and central neuroplastic effect of an early (\<13 weeks after injury) and intensive (8 weeks of 6 hours in addition to usual care) upper limb motor training program (EIUMT) directed at recovery below the level of the injury in pwC-SCI within an international multi-center randomized controlled trial including 44 pwC-SCI. It has 4 objectives: to investigate 1)central neural plasticity by identifying alterations in cortical neuroplasticity and corticospinal excitability; 2)peripheral neural plasticity by identifying alterations in axonal excitability and number of motor units; 3)behavioral motor recovery of upper limb and 4)relationships between dose dimensions of motor intervention and behavioral and neurophysiological outcome measures after EIUMT. Cutting-edge neurophysiological measures are used to provide insight in the mechanism of neuroplasticity after EIUMT and will be taken before and after EIUMT and at 6 months follow-up.

Eligibility

Sex
ALL
Min age
16 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Traumatic or non-traumatic C-SCI in the preceding 13 weeks; age over 16 years; have an incomplete SCI categorized as AIS C or D or an AIS A SCI with zones of partial motor paralysis (as defined by the International Standards for the Neurological Classification of SCI (ISNCI) and medically stable. Exclusion Criteria: * SCI with ASIA Impairment Scale (AIS) A without zones of partial preservation (decided based on former studies) and expertise of the team; SCI with any significant medical condition that could prevent the person from participating. Patients will be excluded from the measures of central plasticity in the presence of contraindications for TMS application such as epilepsy, metal implants in the brain, defibrillator, pacemaker, and pregnancy

Primary outcome measure(s)

  • changes in single pulse TMS: resting motor threshold — - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
    to asses changes in cortical reactivity
  • Changes in Compound Muscle Action Potential (CMAP) — - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
    Changes in amplitude of CMAP
  • changes in GRASSP — - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
    Grades redefined assessment of strength sensibility and Prehension

Trial sites (4)

FacilityCityRegionStatus
Revalidatieziekenhuis RevArte Antwerp Belgium Recruiting
UZGent Ghent Belgium Recruiting
UZLeuven Campus Pellenberg Leuven Belgium Not Yet Recruiting
Zorggroep Adelante Hoensbroek Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06065384 on ClinicalTrials.gov ↗ ← All trials in the Netherlands