Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- The Cleveland Clinic
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)
Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Transcranial magnetic stimulation will be used to test cortical output from both hemispheres and will be measured as motor evoked potentials(MEPS) of the First Dorsal Interosseous (FDI) muscle.
Change in ballistic acceleration
Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Participants perform 10 trials of ballistic index finger abduction with a accelerometer attached to index finger to capture the peak acceleration during the movement.
Change in excitability of spinal physiology (F-wave)
Time Frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Peripheral Nerve stimulation will be performed to collect the spinal F-wave amplitude of the First Dorsal Interosseous (FDI) muscle.
Secondary Outcomes
- Change in finger velocity smoothness during NHPT(Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours)
- Change in Nine Hole Peg Test (NHPT)(Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours)
Investigators
Ela B. Plow
Associate Proffesor
The Cleveland Clinic