Rebuilding Inter-limb Transfer in Cervical SCI

Cervical Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440538
• Other study ID #: 23-415
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 15, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: Kyle J O'Laughlin, MS
• Phone: 216-445-6728
• Email: olaughk[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Lerner Research Institute; Cleveland Clinid Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TMS safety questionnaire	A TMS safety questionnaire will be asked at the end of each TMS testing session	Post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Other	Capabilities of Upper Extremity Test(CUE-T)	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	Baseline
Other	Canadian Occupational Performance Measure (COPM)	COPM is used to measure participation restrictions of Spinal Cord Injury Subjects	Baseline
Other	Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)	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	Baseline
Other	Spinal Cord Independence Measure(SCIM)	SCIM is a spinal cord injury measure that identifies activity limitations of self-care	Baseline
Other	Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)	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.	Baseline
Other	Edinburgh Handedness Inventory	Questionnaire to ascertain the handedness of a participant in activities of daily living (ADL).	Baseline
Primary	Change in ballistic acceleration	Participants perform 10 trials of ballistic index finger abduction with a accelerometer attached to index finger to capture the peak acceleration during the movement.	Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Primary	Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)	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.	Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Primary	Change in excitability of spinal physiology (F-wave)	Peripheral Nerve stimulation will be performed to collect the spinal F-wave amplitude of the First Dorsal Interosseous (FDI) muscle.	Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Secondary	Change in Nine Hole Peg Test (NHPT)	The NHPT is used to measure finger dexterity measured in time to complete the test or amount of pegs placed in 100 sec.	Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Secondary	Change in finger velocity smoothness during NHPT	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.	Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours