Neuromodulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen byHang Jin Jo, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: State University of New York at Buffalo
Must not be taking: Antipsychotics
Disqualifiers: Pulmonary, Cardiovascular, Orthopedic, Depression, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial excludes participants who are taking drugs that affect the central nervous system and lower the seizure threshold, like antipsychotic drugs. If you are on such medications, you may not be eligible to participate.
What data supports the effectiveness of the treatment Motor training, rTMS for spinal cord injury?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve motor function and gait in people with spinal cord injuries. Studies have highlighted its potential to enhance motor recovery and reduce muscle stiffness, suggesting it could be a promising treatment for spinal cord injury.
12345Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) has been used safely in both healthy individuals and those with neuropsychiatric conditions since the 1990s. Safety guidelines have been established and updated over the years, with the most recent in 2021, to ensure safe application, focusing on potential adverse events and precautions.
23467How does the treatment rTMS differ from other treatments for spinal cord injury?
Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, potentially improving motor function and reducing spasticity in spinal cord injury patients. Unlike other treatments, rTMS aims to enhance the brain's ability to reorganize and form new connections, which may help in recovery.
12345Eligibility Criteria
This trial is for adults with or without spinal cord injuries who are interested in participating in a study to improve hand functions. The University at Buffalo aims to understand the connection between the brain, nerves, and muscles.Inclusion Criteria
I am a healthy adult, aged 18-75, and right-handed.
I am between 18 and 75 years old and have had a spinal cord injury.
Exclusion Criteria
Metal plate in skull
I had a condition before my spinal cord injury that made it hard for me to exercise.
Pregnant females
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive rTMS or Sham rTMS with functional and physiological outcomes measured before and after each session
1 day per session
Multiple sessions
Extended Treatment
Participants receive rTMS with motor training for long-term up to 50 sessions
Up to 20 weeks
Weekly sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing neuromodulation techniques like repetitive Transcranial Magnetic Stimulation (rTMS) and motor training exercises. Some participants will receive sham rTMS as a control comparison.
3Treatment groups
Active Control
Placebo Group
Group I: rTMSActive Control1 Intervention
rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
Group II: rTMS with motor trainingActive Control2 Interventions
Subjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training.
Group III: Sham rTMSPlacebo Group1 Intervention
Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Kimball Tower at The State University of New York at BuffaloBuffalo, NY
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Who Is Running the Clinical Trial?
State University of New York at BuffaloLead Sponsor
References
Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. [2011]To assess the effectiveness of physiological outcome measures in detecting functional change in the degree of impairment of spinal cord injury (SCI) following repetitive transcranial magnetic stimulation (rTMS) of the sensorimotor cortex.
Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review. [2022]There is a growing interest in non-invasive stimulation interventions as treatment strategies to improve functional outcomes and recovery after spinal cord injury (SCI). Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulatory intervention which has the potential to reinforce the residual spinal and supraspinal pathways and induce plasticity. Recent reviews have highlighted the therapeutic potential and the beneficial effects of rTMS on motor function, spasticity, and corticospinal excitability modulation in SCI individuals. For this scoping review, we focus on the stimulation parameters used in 20 rTMS protocols. We extracted the rTMS parameters from 16 published rTMS studies involving SCI individuals and were able to infer preliminary associations between specific parameters and the effects observed. Future investigations will need to consider timing, intervention duration and dosage (in terms of number of sessions and number of pulses) that may depend on the stage, the level, and the severity of the injury. There is a need for more real vs. sham rTMS studies, reporting similar designs with sufficient information for replication, to achieve a significant level of evidence regarding the use of rTMS in SCI.
Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. [2021]To assess the effect of high-frequency repetitive transcranial magnetic stimulation (rTMS) on lower extremities motor score (LEMS) and gait in patients with motor incomplete spinal cord injury (SCI).
[Clinical effects of high frequency repeated transcranial magnetic stimulation therapy on dyskinesia in patients with incomplete spinal cord injury:a Meta-analysis]. [2018]To systematically evaluate the clinical effect of high frequency repeated transcranial magnetic stimulation(HF rTMS)therapy on dyskinesia in patients with incomplete spinal cord injury.
Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. [2018]To examine the effects of repetitive QuadroPulse transcranial magnetic stimulation (rTMS(QP)) on hand/leg function after spinal cord injury (SCI).
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. [2019]To evaluate the safety of repetitive transcranial magnetic stimulation (rTMS) in patients with implanted subdural cortical electrodes.