Neuromodulation After Spinal Cord Injury to Improve Limb Function

April 14, 2025 updated by: Hang Jin Jo, State University of New York at Buffalo
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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 Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • The Kimball Tower at The State University of New York at Buffalo
        • Contact:
        • Contact:
          • Hang Jin Jo, PhD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults between the ages of 18-75 years old who are right-handed
  • Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)

Exclusion Criteria:

For both healthy individuals and those with SCI:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  • Any debilitating disease prior to the SCI that caused exercise intolerance
  • Ongoing major depression or altered cognitive status
  • 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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rTMS
rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
Other: rTMS
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 Names:
  • iTBS
Sham Comparator: Sham rTMS
Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
Other: Sham rTMS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Other Names:
  • Sham stimulation
  • Sham iTBS
Active Comparator: rTMS with motor training
Subjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training.
Other: rTMS
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 Names:
  • iTBS
Behavioral: Motor training
The motor training will be focused on participant's hand motor function such as grasping function.
Other Names:
  • Exercise training
  • Hand training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor evoked potentials (MEP)
Time Frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 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 "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum voluntary contraction (MVC)
Time Frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 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 "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.
Power Grip Forces
Time Frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.
Power grip force will be measured with hand-held dynamometer.
For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.

Collaborators and Investigators

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

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Hang Jin Jo, PhD, 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)

April 10, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00007259

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

product manufactured in and exported from the U.S.

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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