Cervical Spinal Cord InjuryEarly Phase 1NCT06440538
Rebuilding Inter-limb Transfer in Cervical SCI
A Early Phase 1 study testing PCMS + Contralateral Motor Training and PCMS + Rest in people with Cervical Spinal Cord Injury, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- PCMS + Contralateral Motor Training and PCMS + Rest
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 30 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lerner Research Institute; Cleveland Clinid Foundation
Cleveland, Ohio, 44195
About this study
Official title: Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains 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.
Read the 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.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- PCMS + Contralateral Motor Training, PCMS + Rest, Sham PCMS + Contralateral Motor Training
- Keywords
- Cervical Spinal Cord Injury, Upper limb, Motor Training, Brain Stimulation, Peripheral Nerve Stimulation, Hand Dexterity, Inter-limb transfer, Motor learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCMS + Contralateral Motor TrainingDevice
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 + RestDevice
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 TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PCMS + Contralateral Motor Training | Experimental | Not described Receives: Device: PCMS + Contralateral Motor Training |
| PCMS + Rest | Active comparator | Not described Receives: Device: PCMS + Rest |
| Sham PCMS + Contralateral Motor Training | Sham comparator | Not described Receives: Device: Sham PCMS + Contralateral Motor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
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.
Measured: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
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.
Measured: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Secondary outcomes (2)
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.
Measured: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
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.
Measured: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Feb 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Ela B. Plow, The Cleveland Clinic
- Investigators
- Ela Plow, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440538
- Sponsor's protocol ID
- 23-415
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI
- ClinicalTrials.gov ID
- NCT06440538
- Acronym / sponsor ID
- 23-415
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCMS + Contralateral Motor Training | Experimental | Device: PCMS + Contralateral Motor Training |
| PCMS + Rest | Active comparator | Device: PCMS + Rest |
| Sham PCMS + Contralateral Motor Training | Sham comparator | Device: Sham PCMS + Contralateral Motor Training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCMS + Contralateral Motor TrainingPCMS + 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. | Device | PCMS + Contralateral Motor Training |
| PCMS + RestPCMS + Rest will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2Hz) to the weaker FDI followed by a 30-min rest. | Device | PCMS + Rest |
| Sham PCMS + Contralateral Motor Training360 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. | Device | Sham PCMS + Contralateral Motor Training |
Primary outcome
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 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 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.
2 secondary outcomes
Change in Nine Hole Peg Test (NHPT)
Time frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Change in finger velocity smoothness during NHPT
Time frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ela Plow, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PCMS + Contralateral Motor Training and PCMS + Rest in people with Cervical Spinal Cord Injury, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ballistic acceleration (time frame: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.