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

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. ^{1 2 3 4 5}

Is 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. ^{2 3 4 6 7}

How 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. ^{1 2 3 4 5}

Research Team

Hang Jin Jo, PhD

Principal Investigator

State University of New York at Buffalo

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. [2011]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. [2021]

4. China 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]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

7. Netherlands 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. [2019]