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

NCT06065384 | Recruiting

• 1 other identifier: REPAIR-SCI_UH
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 4

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord rehabilitation; therapy dose; neural plasticity; motor recovery; upper limb training

Outcome Measures

Primary Outcomes (3)

• changes in single pulse TMS: resting motor threshold

  to asses changes in cortical reactivity

  - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up

• Changes in Compound Muscle Action Potential (CMAP)

  Changes in amplitude of CMAP

  - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up

• changes in GRASSP

  Grades redefined assessment of strength sensibility and Prehension

  - before intervention; at 8 weeks (after intervention) and at 6 months follow-up

Secondary Outcomes (11)

• Single-pulse TMS: Stimulus Response Curve

  - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up

• changes SICI

  - before intervention; at 8 weeks (after intervention) and at 6 months follow-up

• changes in LICI

  - before intervention; at 8 weeks (after intervention) and at 6 months follow-up

• changes in MscanFit MUNE

  - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up

• changes in single pulse TMS: mapping

  - before intervention; at 8 weeks (after intervention) and at 6 months follow-up

Other Outcomes (4)

• Subjectively perceived session difficulty

  measurement of one week during the 2., 5. and 8. week of intervention duration; before and after completion of session

• Objective active time

  - measurement of one week during the 2., 5. and 8. week of intervention duration

• Subjectively perceived session intensity

  measurement of one week during the 2., 5. and 8. week of intervention duration; before and after completion of session

Study Arms (2)

intensive upper limb training

EXPERIMENTAL

The intervention group receives 6 hours of motor training each week upon usual care during 8 weeks. This involves active and targeted motor training of all affected muscles below the injury level in the context of functional activities.

Other: experimental group: intensive motor training

usual care

OTHER

The control group receives only standard rehabilitation and care

Other: usual care

Interventions

experimental group: intensive motor training OTHER

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.

intensive upper limb training

usual care OTHER

usual rehabilitation

usual care

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Annemie Spooren: lead
• Research Foundation Flanders: collaborator
• University of Aarhus: collaborator
• University of Sydney: collaborator
• University Hospital, Ghent: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Adelante, Centre of Expertise in Rehabilitation and Audiology: collaborator
• Rehabilitation Hospital RevArte: collaborator

Study Sites (4)

Revalidatieziekenhuis RevArte

Antwerp, 2650, Belgium

RECRUITING

UZGent

Ghent, Belgium

RECRUITING

UZLeuven Campus Pellenberg

Leuven, Belgium

NOT YET RECRUITING

Zorggroep Adelante

Hoensbroek, Netherlands

RECRUITING

Related Publications (1)

• Hrycyk IJ, Bertels N, Tankisi H, Glinsky JV, Oostra K, van Laake-Geelen C, Tedesco Triccas L, Spooren A. Central and peripheral neuroplasticity in cervical spinal cord injury following intensive upper limb motor training: a randomised controlled trial protocol. BMJ Open. 2026 Mar 18;16(3):e107352. doi: 10.1136/bmjopen-2025-107352.

  PMID: 41857841 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Annemie Spooren, Prof. Dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemie Spooren, Prof. Dr.

CONTACT

11269332; annemie.spooren@uhasselt.be

Lisa Tedesco Triccas, Prof. Dr.

CONTACT

lisa.tedescotriccas@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Annemie Spooren

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: October 3, 2023
• Study Start: October 9, 2024
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): August 28, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: during and after data gathering
• Access Criteria: only for collaborating partners

Locations

NL (1); BE (3)