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NCT Number: NCT06440538

Rebuilding Inter-limb Transfer in Cervical SCI

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.

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Key information

Conditions

Cervical Spinal Cord Injury

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Lerner Research Institute; Cleveland Clinid Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCMS + Contralateral Motor Training

Device

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

Device

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

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Change in Nine Hole Peg Test (NHPT)

    Time frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

    The NHPT is used to measure finger dexterity measured in time to complete the test or amount of pegs placed in 100 sec.

  2. Change in finger velocity smoothness during NHPT

    Time frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

    The investigator will calculate the index finger(2nd digit) velocity smoothness using the number of local maxima of frontal plane finger velocities during the peg transfer phase using kinematic sensors place on the fingers.

Other outcomes

  1. TMS safety questionnaire

    Time frame: Post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

    A TMS safety questionnaire will be asked at the end of each TMS testing session

  2. Capabilities of Upper Extremity Test(CUE-T)

    Time frame: Baseline

    CUE-T is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients

  3. Canadian Occupational Performance Measure (COPM)

    Time frame: Baseline

    COPM is used to measure participation restrictions of Spinal Cord Injury Subjects

  4. Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)

    Time frame: Baseline

    GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients

  5. Spinal Cord Independence Measure(SCIM)

    Time frame: Baseline

    SCIM is a spinal cord injury measure that identifies activity limitations of self-care

  6. Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)

    Time frame: Baseline

    The LTPAQ-SCI is an SCI-specific, self-report assessment of LTPA that measures the number of minutes of mild, moderate, and heavy exercises performed throughout a typical week.

  7. Edinburgh Handedness Inventory

    Time frame: Baseline

    Questionnaire to ascertain the handedness of a participant in activities of daily living (ADL).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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