Neuromodulation to Improve Grasping Function After SCI

April 20, 2026 updated by: Hang Jin Jo, State University of New York at Buffalo

Neuromodulation to Improve Grasping Function After Spinal Cord Injury

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • The State University of New York at Buffalo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: iTBS and PCMS
iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
Other: iTBS
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).
Other: PCMS
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 Comparator: Sham iTBS and PCMS
Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
Other: Sham iTBS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Other: PCMS
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.
Active Comparator: iTBS and PCMS with exercise
Participants will complete iTBS and PCMS with exercise for 10 sessions.
Other: iTBS
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).
Behavioral: Exercise
The motor training will be focused on participant's hand motor function such as grasping function.
Other: PCMS
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 Comparator: Sham iTBS and sham PCMS with exercise
Participants will complete sham stimulation with exercise for 10 sessions.
Other: Sham iTBS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Other: Sham PCMS
During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
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.
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
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.
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00009877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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