Clinical trial NCT06815601: Neuromodulation After Spinal Cord Injury to Improve Limb Function
Official title: Neuromodulation After Spinal Cord Injury to Improve Limb Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Spinal Cord Injury Cervical
Keywords: spinal cord injury
SCI
Stimulation
Paralysis
rTMS
transcranial magnetic stimulation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor evoked potentials (MEP)
timeFrame: 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 outcomes:
measure: Maximum voluntary contraction (MVC)
timeFrame: 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.
measure: Power Grip Forces
timeFrame: 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.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: The Kimball Tower at The State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Hang Jin Jo, PhD
role: PRINCIPAL_INVESTIGATOR
References: