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Cervical Spinal Cord PlasticityNCT07539025

Cervical Spinal Cord Associative Plasticity

A study testing SCAP, MagPro X100 and Digitimer DS8R in people with Cervical Spinal Cord Plasticity, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Associative plasticity has been used to promote functional recovery from conditions affecting movement. Prior work from the Carmel laboratory has shown that paired associative stimulation protocols timed to converge in the cervical spinal cord induce significantly larger upper limb motor responses than if timed to… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Spinal Cord Plasticity
What is being tested?
SCAP, MagPro X100 and Digitimer DS8R
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
9 May 2026to Jun 2029
Phase
Interventional
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Willingness to participate in up to 4 sessions
  • Maintenance of caffeine and exercise levels at time of sessions
  • Ability to provide informed consent
  • No known central or peripheral neurological disease or injury
  • No known musculoskeletal injury of the tested arm or hand

Who cannot join

  • Personal or family history of seizures
  • Use of medications that lower seizure threshold
  • History of implanted equipment including stimulators/pacemakers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shaker Dukkipati, MD, PhD contact

2123046501

sd3850@cumc.columbia.edu

Jason Carmel, MD, PhD contact

jbc28@cumc.columbia.edu

United States1 site, 1 recruiting
  • Columbia University Irving Medical Center

    New York, New York, 10040

    Jason Carmel, MD, PhD, 212-305-2700 ext. 3, jbc28@cumc.columbia.edu

    Recruiting

Other trials in United States

About this study

Official title: Paired Non-invasive Stimulation of Hand Motor Cortex and Median Nerve to Induce Plasticity in the Cervical Spinal Cord

Associative plasticity has been used to promote functional recovery from conditions affecting movement. Prior work from the Carmel laboratory has shown that paired associative stimulation protocols timed to converge in the cervical spinal cord induce significantly larger upper limb motor responses than if timed to converge in the motor cortex.

The goal of this prospective experimental study in typically developing adults is to test the effects of pairing sub-threshold hand motor cortical and median nerve stimulation targeted to induce plasticity in the cervical spinal cord, rather than in the motor cortex. Based on preliminary data, the investigators are performing a confirmatory study to test the physiological and behavioral effects of the paired brain and peripheral nerve protocol, called the SCAP-Nerve protocol.

This study will first be conducted in typically developing adults to confirm the cervical spinal cord as the ideal target and verify the present stimulation parameters are sufficient to promote induction of associative plasticity of sensorimotor connections for manual dexterity. The outcomes from this study could then be translated to efficacy studies in people with spinal cord injury and cerebral palsy to promote clinically meaningful improvements in dexterity.

Read the detailed description

Associative plasticity has been used to promote functional recovery in patient populations, such as adults with spinal cord injuries (SCI). Using non-invasive neuromodulation approaches, pairing of motor cortical stimulation and peripheral nerve stimulation has been shown to augment motor responses and promote plasticity, primarily through the convergence of sensory afferent stimuli and descending cortical stimuli in the motor cortex.

However, prior work from the Carmel laboratory has shown that paired associative stimulation timed to converge in the cervical spinal cord induces significantly larger upper limb motor responses than if timed to converge in the motor cortex. While paired associative stimulation has shown promise for strengthening motor responses, it is unclear if plasticity from convergence of non-invasive stimuli in the spinal cord (termed spinal cord associative plasticity or SCAP) instead of the motor cortex can produce greater motor effects, and potentially greater promotion of movement recovery.

The goal of this present study is to test the effects of pairing sub-threshold hand motor cortical and median nerve stimulation targeted to induce plasticity in the cervical spinal cord, rather than in the motor cortex. The investigators aim to fill a knowledge gap regarding the ideal target of non-invasive stimulation to maximize associative plasticity for upper limb movement recovery. The study hypothesis is that pairing low-intensity stimulation of the hand motor cortex with low-intensity median nerve stimulation will produce associative plasticity in the cervical spinal cord measured through augmentation of motor responses in upper limb muscles.

Based on preliminary data, the investigators are performing a confirmatory study to test the physiological and behavioral effects of the paired brain and peripheral nerve protocol, called the SCAP-Nerve protocol. This protocol uses a specific set of TMS (transcranial magnetic stimulation) and PNS (peripheral nerve stimulation) parameters: targeting hand motor cortex at 90% resting motor threshold and targeting median nerve sensory afferents (with a nerve stimulus pulse duration of 1000 microseconds) at 90% resting motor threshold, precisely timed to converge in the cervical spinal cord.

This study will first be conducted with a single session of 90 trials of pairing in typically developing adults to confirm the cervical spinal cord as the ideal target and verify the present stimulation parameters as sufficient to promote induction of associative plasticity of sensorimotor connections for manual dexterity. Prior work from the Carmel laboratory has shown that the magnitude and duration of lasting effects of paired motor cortex and afferent stimulation is similar in rodents with and without neural injury.

This then drives the premise for this study that the identification of the cervical spinal cord as an ideal target for associative plasticity involving cortical and sensory afferents would inform translation to people suffering from neurological injuries such as spinal cord injury and cerebral palsy. The outcomes from this study could be translated to efficacy studies in these patient populations to determine if this plasticity is present in those populations as well. This could then lead to the investigation of whether pairing brain and afferent-targeted nerve stimulation for convergence in the cervical spinal cord can lead to clinically meaningful improvements in manual dexterity.

Being tested
SCAP, MagPro X100, Digitimer DS8R, Paired non-associative stimulation
Keywords
cervical spinal cord, paired associative stimulation, motor evoked potential, spinal cord injury, cerebral palsy, manual dexterity, corticospinal, sensory afferent, SCAP, spinal cord associative plasticity
Medical subject headings
Spinal Cord Injuries, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCAPOther

    This utilizes pairing of repetitive transcranial magnetic stimulation (rTMS) and peripheral nerve stimulation (rPNS) timed to converge in the cervical spinal cord.

  • MagPro X100Device

    This stimulator will be use to provide repetitive transcranial magnetic stimulation (rTMS).

  • Digitimer DS8RDevice

    This stimulator will be used to provide repetitive peripheral nerve stimulation (rPNS).

  • Paired non-associative stimulationOther

    This utilizes pairing of repetitive transcranial magnetic stimulation (rTMS) and peripheral nerve stimulation (rPNS) timed to arrive at a pairing interval of 40 msec.

Study groups in NCT07539025
Study groupRoleWhat they receive
SCAPExperimentalWith this session, participants will receive 90 trials of 0.1hz paired motor cortical stimulation and median nerve stimulation for 15 minutes at sub-threshold intensities, timed to converge in the cervical spinal cord simultaneously.
Receives: Other: SCAP
Cortical stimulation onlyActive comparatorWith this session, participants will receive 90 trials of 0.1hz motor cortical stimulation for 15 minutes at sub-threshold intensities.
Receives: Device: MagPro X100
Median nerve stimulation onlyActive comparatorWith this session, participants will receive 90 trials of 0.1hz median nerve stimulation for 15 minutes at sub-threshold intensities.
Receives: Device: Digitimer DS8R
Paired non-associative stimulationActive comparatorWith this session, participants will receive 90 trials of 0.1hz paired motor cortical stimulation and median nerve stimulation for 15 minutes at sub-threshold intensities, timed to be 40 milliseconds apart in the cervical spinal cord.
Receives: Other: Paired non-associative stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Size of muscle response to brain stimulation after SCAP (percentage)

    Size of muscle response will be measured in response to brain stimulation. This value will be normalized to the equivalent measure taken before the SCAP protocol.

    Measured: 30 minutes after SCAP

Secondary outcomes (6)
  1. Size of muscle response to nerve stimulation during combined brain and nerve stimulation after SCAP (percentage)

    Size of muscle response will be measured in response to brain and median nerve stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.

    Measured: Immediately after intervention, up to 1 minute

  2. Size of muscle response to nerve stimulation during combined brain and nerve stimulation (percentage)

    Size of muscle response will be measured in response to brain and median nerve stimulation timed to converge in the spinal cord. This value will be normalized to the muscle response for nerve only stimulation.

    Measured: Immediately after intervention, up to 1 minute

  3. Size of muscle response to nerve stimulation during combined brain and nerve stimulation after SCAP (percentage)

    Size of muscle response will be measured in response to brain and median nerve stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.

    Measured: 30 minutes after SCAP

  4. Duration of effect of SCAP on subsequent responses to brain stimulation

    Time in minutes taken for the size of muscle response to fall to 50% of its maximal post-SCAP level.

    Measured: 30 minutes after SCAP

  5. Pinch force variability

    The coefficient of variation of the pinch opposition strength between the tips of the thumb and the second finger using a handheld dynamometer. This will be recorded and compared to baseline measurements.

    Measured: 30 minutes after SCAP

  6. Pinch force speed

    The rate of force development of the pinch opposition strength between the tips of the thumb and the second finger using a handheld dynamometer. This will be recorded and compared to baseline measurements.

    Measured: 30 minutes after SCAP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start9 May 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
All participants will undergo all arms of the study. They will first receive the SCAP protocol, which is the source of the primary investigation in this study. Then, they will receive the three comparator arms in randomized order over multiple sessions timed at least 24 hours apart to minimize carryover effects.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07539025
Sponsor's protocol ID
AAAV2760-TD
Status last verified
May 2026
First submitted
13 Apr 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Ling YT, Alam M, Zheng YP. Spinal Cord Injury: Lessons about Neuroplasticity from Paired Associative Stimulation. Neuroscientist. 2020 Jun;26(3):266-277. doi: 10.1177/1073858419895461. Epub 2019 Dec 31.

    PubMed 31889474
  • Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016.

    PubMed 28053760
  • Delvendahl I, Jung NH, Kuhnke NG, Ziemann U, Mall V. Plasticity of motor threshold and motor-evoked potential amplitude--a model of intrinsic and synaptic plasticity in human motor cortex? Brain Stimul. 2012 Oct;5(4):586-93. doi: 10.1016/j.brs.2011.11.005. Epub 2012 Feb 28.

    PubMed 22445536
  • Stefan K, Kunesch E, Cohen LG, Benecke R, Classen J. Induction of plasticity in the human motor cortex by paired associative stimulation. Brain. 2000 Mar;123 Pt 3:572-84. doi: 10.1093/brain/123.3.572.

    PubMed 10686179
  • Murray LM, McIntosh JR, Goldsmith JA, Wu YK, Liu M, Sanford SP, Joiner EF, Mandigo C, Virk MS, Tyagi V, Carmel JB, Harel NY. Timing-dependent synergies between noninvasive motor cortex and spinal cord stimulation in chronic cervical spinal cord injury. medRxiv [Preprint]. 2025 Apr 27:2025.04.17.25326011. doi: 10.1101/2025.04.17.25326011.

    PubMed 40313296
  • Murray LM, McIntosh JR, Goldsmith JA, Wu YK, Liu M, Sanford SP, Joiner EF, Mandigo C, Tyagi V, Virk MS, Carmel JB, Harel NY. Timing-dependent synergies between noninvasive motor cortex and spinal cord stimulation in chronic cervical spinal cord injury. Clin Neurophysiol. 2025 Dec;180:2111372. doi: 10.1016/j.clinph.2025.2111372. Epub 2025 Oct 10.

    PubMed 41106070
  • Pal A, Park H, Ramamurthy A, Asan AS, Bethea T, Johnkutty M, Carmel JB. Spinal cord associative plasticity improves forelimb sensorimotor function after cervical injury. Brain. 2022 Dec 19;145(12):4531-4544. doi: 10.1093/brain/awac235.

    PubMed 36063483

Questions about this trial

What is this clinical trial studying?

A study testing SCAP, MagPro X100 and Digitimer DS8R in people with Cervical Spinal Cord Plasticity, run by Columbia University 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Contact Shaker Dukkipati, MD, PhD (2123046501, sd3850@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Size of muscle response to brain stimulation after SCAP (percentage) (time frame: 30 minutes after SCAP). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539025, which also lists 7 linked publications.

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 22 May 2026.

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