NCT06065384 Neural Plasticity and Motor Recovery After Upper Extremity Motor Training in People With c-SCI
| NCT ID | NCT06065384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Annemie Spooren |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2027-03-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-10-09 with a primary completion date of 2027-03-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Annemie Spooren, Prof. Dr.
PRINCIPAL INVESTIGATOR
Hasselt University
Frequently Asked Questions
Who can join the NCT06065384 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 90 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06065384 currently recruiting?
Yes, NCT06065384 is actively recruiting participants. Contact the research team at annemie.spooren@uhasselt.be for enrollment information.
Where is the NCT06065384 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Ghent, Belgium, Leuven, Belgium, Hoensbroek, Netherlands.
Who is sponsoring the NCT06065384 clinical trial?
NCT06065384 is sponsored by Annemie Spooren. The principal investigator is Annemie Spooren, Prof. Dr. at Hasselt University. The trial plans to enroll 44 participants.