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NCT Number: NCT07433959

Neuromodulation to Improve Grasping Function After SCI

The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location status: Recruiting

Location contact

Karen Barnes

CONTACT

[email protected]

716-829-6718

About this study

The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For individuals with SCI:

  • Ages 18-75 years
  • Chronic SCI (≥1 year of injury)
  • Cervical injury at C8 or above
  • Individuals who have MEP responses in at least one FDI muscle

Exclusion criteria

  • Uncontrolled medical problems including pulmonary or cardiovascular disease
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke
  • Metal plate in skull
  • History of seizures
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
  • Pregnant females
  • Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical

Treatment and study plan

iTBS

Other

Intermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses in 190 seconds).

Sham iTBS

Other

Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.

PCMS

Other

During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.

Sham PCMS

Other

During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.

Exercise

Behavioral

The motor training will be focused on participant's hand motor function such as grasping function.

Primary outcomes

  1. Motor evoked potential (MEP)

    Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

    Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.

Secondary outcomes

  1. Maximum voluntary contraction (MVC)

    Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

    Individuals will perform a MVC of the targeted hand muscle (first dorsal interosseous) through surface EMG electrodes. The investigators will collect two MVC trials and use the average of the two.

  2. Grip force

    Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

    Grip force will be assessed with hand grip dynamometer. The highest value of the three trials will be used.

  3. Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)

    Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

    TRI-HFT is clinical assessment tool to measure specifically unilateral pinch and grasp hand function.

Study contacts

Contact information is provided by the study sponsor or research team.

Hang Jin Jo, PhD

CONTACT

[email protected]

716-829-2905

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Neuromodulation to Improve Grasping Function After Spinal Cord Injury

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Apr 23, 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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