Clinical trial NCT06440538: Rebuilding Inter-limb Transfer in Cervical SCI
Official title: Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cervical Spinal Cord Injury
Keywords: Cervical Spinal Cord Injury
Upper limb
Motor Training
Brain Stimulation
Peripheral Nerve Stimulation
Hand Dexterity
Inter-limb transfer
Motor learning
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2024-06-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ballistic acceleration
timeFrame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
measure: Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)
timeFrame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
measure: Change in excitability of spinal physiology (F-wave)
timeFrame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Secondary outcomes:
measure: Change in Nine Hole Peg Test (NHPT)
timeFrame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
measure: Change in finger velocity smoothness during NHPT
timeFrame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Other outcomes:
measure: TMS safety questionnaire
timeFrame: Post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
measure: Capabilities of Upper Extremity Test(CUE-T)
timeFrame: Baseline
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline
measure: Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
timeFrame: Baseline
measure: Spinal Cord Independence Measure(SCIM)
timeFrame: Baseline
measure: Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)
timeFrame: Baseline
measure: Edinburgh Handedness Inventory
timeFrame: Baseline
Locations:
city: Cleveland
country: United States
facility: Lerner Research Institute; Cleveland Clinid Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ela Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References: