Transcranial Magnetic Stimulation for Spinal Cord Injury

(NIBS-SCI1 Trial)

Overseen By Sapna Kumar, MSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: Ventilator dependence, Brain injury, Pregnancy, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new treatment to improve hand and arm function in individuals who have experienced a spinal cord injury. The treatment uses transcranial magnetic stimulation (TMS), a non-invasive method that employs magnetic fields to stimulate nerve cells. This approach is part of NIBS Therapy. Participants will be divided into two groups: one receiving active TMS and the other receiving a sham (placebo) version. Individuals who have suffered a cervical spinal cord injury within the last six weeks and have some paralysis in their arms or hands may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in spinal cord injury recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial magnetic stimulation is safe for spinal cord injury patients?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for people with spinal cord injuries. Studies have found that it can improve movement and reduce pain. Early results suggest that most people tolerate it well. These studies have reported no serious side effects. However, some individuals might experience minor side effects, such as headaches or scalp discomfort. Overall, evidence suggests that TMS is a promising and safe treatment option for those with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for spinal cord injury because it offers a non-invasive way to potentially enhance motor function. Unlike traditional treatments that might focus on rehabilitation exercises or surgical interventions, TMS uses targeted magnetic fields to stimulate specific brain areas, potentially improving communication between the brain and the spinal cord. This trial uses high-frequency rTMS, informed by advanced e-field modeling and neuronavigation, which allows for precise targeting and potentially more effective outcomes. By exploring this innovative approach, researchers hope to unlock new pathways for recovery that current therapies can't achieve.

What evidence suggests that transcranial magnetic stimulation is effective for spinal cord injury?

Research shows that non-invasive brain stimulation (NIBS) can enhance movement in people with spinal cord injuries. Studies have found positive effects on movement, although results can vary. In this trial, participants will receive either active high-frequency repetitive transcranial magnetic stimulation (rTMS) or a sham version. High-frequency rTMS, a type of NIBS, has shown promise when combined with rehabilitation exercises. Early findings suggest it may aid in the recovery of motor skills for those with spinal cord injuries. Overall, these initial results encourage using NIBS to support recovery after such injuries. ^{1 2 4 5 6}

Who Is on the Research Team?

Dylan J Edwards, PhD

Principal Investigator

Albert Einstein Healthcare Network

Are You a Good Fit for This Trial?

This trial is for individuals with recent spinal cord injuries leading to quadriplegia, which means paralysis of all four limbs. Participants should be in the subacute phase, meaning they are past the initial injury but not yet fully stable. The study excludes those with certain medical conditions or metal implants that interfere with magnetic stimulation.

Inclusion Criteria

I have some feeling or movement in areas affected by my spinal injury.

Time post-injury less than six weeks

I have paralysis in my arms due to a spinal cord injury.

Exclusion Criteria

I experience severe muscle, bone, or nerve pain.

Known or suspected pregnancy

Medically unstable or any reason the physician may deem as inappropriate for the participant to enroll or continue in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily transcranial magnetic stimulation treatment for 2 weeks at an inpatient rehabilitation facility

2 weeks

10 daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline and 6 months post-injury

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NIBS Therapy

Trial Overview The trial is testing a new therapy using transcranial magnetic stimulation (rTMS) to potentially repair motor pathways and improve hand and arm function after spinal cord injury. Patients will receive either active rTMS or a sham (fake) treatment as part of their rehabilitation.

How Is the Trial Designed?

Group I: Active rTMS Active Control 1 Intervention

10 daily sessions of High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigation system for precise targeting during each intervention session. Active group will receive HF-rTMS intensity calculated using electric field modelling to create electric field intensity of approximately motor threshold, using the cool-B65 A/P rTMS coil.

Group II: Sham rTMS Placebo Group 1 Intervention

10 daily sessions of Sham High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigational system for precise targeting during each intervention session Sham group receives no active magnetic stimulation. Cool-B65 A/P rTMS coil will be used to avoid unblinding of administrator and/or study participant.

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

University of Sao Paulo

Collaborator

Trials

1,091

Recruited

266,000+

Burke Medical Research Institute

Collaborator

Trials

24

Recruited

1,500+

Pennsylvania Department of Health

Collaborator

Trials

42

Recruited

999,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

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]

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]

Combining robot-assisted rehabilitation (RAR) with non-invasive brain stimulation (NIBS) significantly improves lower extremity motor function in adults with incomplete spinal cord injury compared to RAR alone, as shown by greater improvements in tests like the 10 m walk test and the Functional Independence Measure-Locomotion.

No adverse effects were reported during the trial, indicating that the combined approach of RAR and NIBS is safe for participants, but further research with larger groups is needed to explore long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding the Way to Improve Motor Recovery of Patients with Spinal Cord Lesions: A Case-Control Pilot Study on a Novel Neuromodulation Approach. Naro, A., Billeri, L., Balletta, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837916/

Effects of non-invasive brain stimulation on motor function ... NIBS appears to positively affect the motor function of the lower extremities in SCI patients, despite the marginal P-value and the high heterogeneity.

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/neuroscience/articles/10.3389/fnins.2021.800560/full

Non-invasive Brain Stimulation for Neuropathic Pain After ... This study aims to systematically evaluate the effect of non-invasive brain stimulation (NIBS) on neuropathic pain (NP) after spinal cord injury

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01129-4

Effects of non-invasive brain stimulation on motor function ... NIBS appears to positively affect the motor function of the lower extremities in SCI patients, despite the marginal P-value and the high heterogeneity.

5. tandf.figshare.com tandf.figshare.com/articles/dataset/Effectiveness_of_high-frequency_repetitive_transcranial_magnetic_stimulation_coupled_with_rehabilitation_in_patients_with_spinal_cord_injury_a_systematic_review/30090919

Effectiveness of high-frequency repetitive transcranial ... Effectiveness of high-frequency repetitive transcranial magnetic stimulation coupled with rehabilitation in patients with spinal cord injury: a

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5674824/

Effects of high-frequency transcranial magnetic stimulation on ... Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study ...