Neuromodulation for Spinal Cord Injury

Overseen By Hang Jin Jo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: Antipsychotics

Disqualifiers: Pulmonary, Cardiovascular, Orthopedic, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day per session

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain, nerves, and muscles coordinate hand movements, focusing on individuals with spinal cord injuries. Researchers aim to determine if repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation, can improve hand function. Participants will be divided into groups, with some receiving actual rTMS and motor training, while others receive a sham (inactive) version for comparison. The trial seeks healthy, right-handed adults or those with spinal cord injuries, provided they do not have certain medical issues like uncontrolled heart or lung problems. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance rehabilitation techniques.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated. Studies have found it to be a safe treatment for individuals with upper motor neuron (UMN) injuries, such as spinal cord injuries (SCI). Side effects are rare and typically mild, such as headaches or slight discomfort at the treatment site.

Some studies have also considered adding motor training to rTMS, deeming it safe. This combination aims to improve muscle strength and function. Experts recommend rTMS because it shows promise in helping individuals with SCI regain movement. Overall, these therapies have a strong safety record in similar patient groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using repetitive transcranial magnetic stimulation (rTMS) for spinal cord injury because it offers a non-invasive way to stimulate neural activity and potentially enhance recovery. Unlike traditional treatments that might focus on physical rehabilitation alone, rTMS targets the brain's motor areas directly, potentially improving motor function more effectively. Additionally, combining rTMS with motor training could amplify these benefits, offering a more comprehensive approach to rehabilitation. This method stands out for its ability to precisely target and modulate brain activity, which might lead to faster and more significant improvements in patients' abilities to move and function.

What evidence suggests that this trial's treatments could be effective for improving hand functions in people with spinal cord injuries?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), a treatment under study in this trial, might benefit people with spinal cord injuries. Studies have found that rTMS can reduce muscle stiffness and increase muscle strength in both the upper and lower body. Some participants in this trial will receive rTMS alone, while others will receive rTMS combined with motor training. Research suggests that combining rTMS with movement training might further aid recovery. While the results are promising, not all studies agree, so more research is needed to confirm these benefits. ^{2 3 5 6 7}

Who Is on the Research Team?

Hang Jin Jo, PhD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Motor training
• rTMS

Trial Overview 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.

How Is the Trial Designed?

Group I: rTMS Active Control 1 Intervention

rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.

Group II: rTMS with motor training Active Control 2 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 rTMS Placebo Group 1 Intervention

Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

High-frequency repetitive transcranial magnetic stimulation (rTMS) significantly improved lower extremities motor score (LEMS) and various gait parameters in 17 patients with motor incomplete spinal cord injury after 15 sessions, with effects lasting for at least 2 weeks.

The active rTMS group showed notable improvements in spasticity and gait metrics, while the sham group did not demonstrate significant changes, highlighting the efficacy of rTMS as a therapeutic intervention for enhancing motor function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Benito, J., Kumru, H., Murillo, N., et al.[2021]

In a study involving subjects with spinal cord injury (SCI), real repetitive transcranial magnetic stimulation (rTMS) did not show significant differences in the ASIA impairment scale compared to sham treatment, indicating limited efficacy in this specific measure.

However, rTMS did lead to short-term improvements in upper limb function as measured by the Action Research Arm Test (ARAT) and increased motor thresholds, suggesting that electrophysiological measures could be valuable in assessing functional changes in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. Kuppuswamy, A., Balasubramaniam, AV., Maksimovic, R., et al.[2011]

In a proof-of-concept study involving three adults with cervical spinal cord injury, repetitive QuadroPulse transcranial magnetic stimulation (rTMS(QP)) showed functional benefits, particularly in improving walking speed and cortical excitability without any adverse effects.

The combination of rTMS(QP) with targeted exercises led to even greater improvements in motor function, suggesting that this approach could be effective and warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. Alexeeva, N., Calancie, B.[2018]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment to enhance recovery and functional outcomes in individuals with spinal cord injury (SCI), with potential benefits for motor function and spasticity based on a review of 16 studies.

Future research should focus on optimizing rTMS parameters, such as timing and dosage, and emphasize the need for more rigorous studies comparing real versus sham rTMS to strengthen the evidence for its efficacy in SCI rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review. Brihmat, N., Allexandre, D., Saleh, S., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

High frequency repeated transcranial magnetic stimulation (HF rTMS) therapy significantly improved motor function in patients with incomplete spinal cord injury, as evidenced by increased ASIA motor scores and lower extremities motor scores in a study of 103 patients.

HF rTMS therapy also reduced spasticity in the lower extremities, but did not show a significant effect on walking ability as measured by the Walking Index for Spinal Cord Injury II (WISCI II).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effects of high frequency repeated transcranial magnetic stimulation therapy on dyskinesia in patients with incomplete spinal cord injury:a Meta-analysis]. Gao, ZC., Niu, BB., Gu, MC., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7526137/

Effects of Repetitive Transcranial Magnetic Stimulation on ... Overall, rTMS has been used to target three main consequences of SCI: a) sensory and motor function impairments, b) spasticity, and c) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425000530

nTMS in spinal cord injury: Current evidence, challenges ... nTMS has shown encouraging preliminary results in both clinical assessment and rehabilitation (motor and pain) of patients with SCI.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1587060/full

Repetitive transcranial magnetic stimulation for enhancing ... In individuals with SCI, rTMS protocols effectively reduced spasticity (5 out of 8 studies), increased muscle strength in the upper and lower ...

4. nature.com nature.com/articles/s41393-021-00703-8

a randomized controlled trial | Spinal Cord High-frequency rTMS may increase long-term training-induced recovery of lower limb muscle strength following SCI. The effect on short-term recovery is unclear.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02899637

Effects of Transcranial Magnetic Stimulation in Incomplete ... The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05333770

Study Details | NCT05333770 | Repetitive Transcranial ... Be less than 8 weeks post injury; Must have an incomplete spinal cord injury at a neurological level of injury between the C2-C6 level and an impairment grade A ...