Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
17 participants
INTERVENTIONAL
2024-02-15
2026-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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PCMS + Contralateral Motor Training
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.
PCMS + Rest
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.
Sham PCMS + Contralateral Motor Training
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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The Craig H. Neilsen Foundation
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Ela B. Plow
Associate Proffesor
Principal Investigators
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Ela Plow, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Lerner Research Institute; Cleveland Clinid Foundation
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-415
Identifier Type: -
Identifier Source: org_study_id
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