Skip to content

Neuromodulation After Spinal Cord Injury to Improve Limb Function

Neuromodulation After Spinal Cord Injury to Improve Limb Function

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815601
Enrollment
60
Registered
2025-02-07
Start date
2025-04-10
Completion date
2028-01-31
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury, Spinal Cord Injury Cervical

Keywords

spinal cord injury, SCI, Stimulation, Paralysis, rTMS, transcranial magnetic stimulation

Brief summary

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.

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.

Interventions

OTHERrTMS

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).

OTHERSham rTMS

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

BEHAVIORALMotor training

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

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Motor evoked potentials (MEP)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.

Secondary

MeasureTime frameDescription
Maximum voluntary contraction (MVC)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.
Power Grip ForcesFor 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.

Countries

United States

Contacts

Primary ContactHang Jin Jo, PhD
hangjinj@buffalo.edu716-829-2905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026