NCT06440538

Rebuilding Inter-limb Transfer in Cervical SCI

Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills.

Detailed description

Cervical spinal cord injury (SCI) is the most common and severe type of SCI that can lead to paralysis of the trunk and all four limbs, also known as tetraplegia. People with tetraplegia place a high priority on regaining upper limb motor function to be independent in daily life. Despite intensive therapies, upper limb motor gains are slow to emerge, especially in chronic cases. A critical barrier to effective and efficient upper limb rehabilitation in cervical SCI lies in the motor deficits of inter-limb transfer. Inter-limb transfer refers to a natural innate process within the human neuromotor system that motor skills acquired in one limb can transfer to the opposite, untrained limb, and is believed to play a key role in maximizing and accelerating post-injury recovery. Inter-limb transfer however is deficient following cervical SCI due to a breakdown of inter-limb neural connections at the cortical and spinal levels. Prior studies in uninjured people reveal that one can upregulate inter-limb neural mechanisms and hence augment inter-limb transfer effects by giving neurostimulation to augment corticomotoneuronal pathways to the untrained arm just before motor training in the contralateral arm. This study aims to rebuild inter-limb transfer of motor gains in chronic cervical SCI using a novel non-invasive neurostimulation method called paired corticospinal-motor neuronal stimulation (PCMS). We will test the central hypothesis that PCMS given to an untrained hand immediately before the visuomotor ballistic motor training at the other hand will improve inter-limb transfer of ballistic motor and dexterity skills to the untrained hand, based on potentiation of inter-limb neural mechanisms.

Conditions

• Cervical Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	PCMS + Contralateral Motor Training	PCMS + Contralateral Motor Training will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2 Hz) to the weaker first dorsal interosseous (FDI) muscle immediately before a session of ballistic index finger abduction training at the opposite, stronger FDI muscle.
DEVICE	PCMS + Rest	PCMS + Rest will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2Hz) to the weaker FDI followed by a 30-min rest.
DEVICE	Sham PCMS + Contralateral Motor Training	360 TMS pulses will be delivered at a location 10-cm posterior to the participant's head (into the air, 0.2Hz) and no PNS pulses will be generated, followed by a session of 30-min ballistic index finger abduction training at the opposite, stronger FDI muscle.

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2024-06-04
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study