20 Participants Needed

Transcranial Magnetic Stimulation for Spinal Cord Injury

(NIBS-SCI1 Trial)

SK
Overseen BySapna Kumar, MSE
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Albert Einstein Healthcare Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. A robust neural repair strategy has been demonstrated in preclinical studies, that is ready for translation to recovery of hand and arm function in human SCI, comprising daily transcranial magnetic stimulation treatment at the inpatient rehabilitation facility. This study will establish clinical effect size of the intervention, as well as safety and feasibility necessary for a subsequent controlled efficacy trial and inform preclinical studies for dosing optimization.

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 data supports the effectiveness of the treatment NIBS Therapy for spinal cord injury?

Research suggests that transcranial magnetic stimulation (TMS), a part of NIBS Therapy, may help improve motor function and walking ability in people with incomplete spinal cord injuries. Some studies have shown positive effects on hand and leg function, indicating potential benefits for rehabilitation.12345

Is transcranial magnetic stimulation safe for humans?

Research shows that transcranial magnetic stimulation (TMS) is generally safe for humans, as studies report no side effects during or after treatment in patients with spinal cord injury.24678

How is NIBS Therapy different from other treatments for spinal cord injury?

NIBS Therapy, which involves transcranial magnetic stimulation (TMS), is unique because it uses magnetic fields to stimulate nerve cells in the brain, potentially improving motor function and gait in spinal cord injury patients. Unlike traditional treatments that may focus on physical rehabilitation or medication, TMS is non-invasive and directly targets brain activity to promote recovery.12359

Research Team

DJ

Dylan J Edwards, PhD

Principal Investigator

Albert Einstein Healthcare Network

Eligibility Criteria

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 am between 18 and 80 years old.
I have some feeling or movement in areas affected by my spinal injury.
ASIA Impairment Scale (AIS) A-C
See 3 more

Exclusion Criteria

I experience severe muscle, bone, or nerve pain.
I have no history of seizures and can safely undergo TMS.
Known or suspected pregnancy
See 7 more

Timeline

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

Treatment Details

Interventions

  • NIBS Therapy
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMSActive Control1 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 rTMSPlacebo Group1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Retraction of "Effects of High-Frequency Repetitive Transcranial Magnetic Stimulation on Motor and Gait Improvement in Incomplete Spinal Cord Injury Patients". [2019]
Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. [2021]
Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. [2018]
Therapeutic Application of Transcranial Magnetic Stimulation Combined with Rehabilitative Training for Incomplete Spinal Cord Injury: A Case Report. [2022]
Transcranial magnetic stimulation after spinal cord injury. [2016]
The Regenerative Effect of Trans-spinal Magnetic Stimulation After Spinal Cord Injury: Mechanisms and Pathways Underlying the Effect. [2021]
Finding the Way to Improve Motor Recovery of Patients with Spinal Cord Lesions: A Case-Control Pilot Study on a Novel Neuromodulation Approach. [2023]
Motor-evoked potentials from various levels of paravertebral muscles in normal subjects and in patients with focal lesions of the spinal cord. [2019]
Treatment of patients with cervical and upper thoracic incomplete spinal cord injury using repetitive transcranial magnetic stimulation. [2022]