Rebuilding Inter-limb Transfer in Cervical SCI

NeuroTherapia, Inc.

Status and phase: Enrolling; Early Phase 1

Conditions: Cervical Spinal Cord Injury

Treatments: Device: PCMS + Contralateral Motor Training; Device: PCMS + Rest; Device: Sham PCMS + Contralateral Motor Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06440538

23-415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Neurological Level of Injury C4, C5, C6, C7, C8
• American Spinal Injury Association Impairment Scale (AIS) C-D
• greater than or equal to 1 year time post injury
• residual motor sparing of bilateral FDI muscles, defined as medical research council (MRC) grade 2 to 5

Exclusion criteria

• contraindications to transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) including pacemaker, metal in the skull, seizure history, pregnancy, etc.
• history of alcohol and/or drug abuse
• current usage of medications that can potentially lower the seizure threshold such as bupropion, amphetamines, etc.
• history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI)
• active pressure ulcers to avoid disruption of ongoing medical treatments
• participation of on-going upper-limb therapies to minimize confounding effects
• excessive tone/spasticity (Modified Ashworth Scale [MAS] >3) and severe contractures or soft tissue shortening at elbow/wrist/fingers

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 3 patient groups

PCMS + Contralateral Motor Training

Experimental group

Treatment:

Device: PCMS + Contralateral Motor Training

PCMS + Rest

Active Comparator group

Treatment:

Device: PCMS + Rest

Sham PCMS + Contralateral Motor Training

Sham Comparator group

Treatment:

Device: Sham PCMS + Contralateral Motor Training