Transcranial Magnetic Stimulation for Spinal Cord Injury

(uMEP Trial)

Overseen By Blair Dellenbach, MSOT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Anti-spasticity

Disqualifiers: Motoneuron injury, Epileptic seizures, others

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

Compensation: Varies

Number of Visits: 30

Duration: 10 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI). This study requires 30 visits, and each visit will last approximately 1.5 hours.

Will I have to stop taking my current medications?

The trial requires that you keep your current medications the same for at least 3 months. If you are using anti-spasticity medications like baclofen, diazepam, or tizanidine, you can continue taking them as usual.

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) has been used in various studies with people who have spinal cord injuries, and no major safety concerns have been reported. It is generally considered safe when used under proper medical supervision. ^{1 2 3 4 5}

How does the treatment MEP Operant Up-conditioning of the Wrist Extensor differ from other treatments for spinal cord injury?

This treatment is unique because it uses transcranial magnetic stimulation (TMS) to enhance motor evoked potentials (MEPs), which are signals that help control muscle movement, specifically targeting the wrist extensor muscles. Unlike other treatments, it focuses on conditioning these signals to improve hand function, which is particularly beneficial for individuals with spinal cord injuries affecting their hand and wrist movements. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment MEP Operant Up-conditioning of the Wrist Extensor for spinal cord injury?

Research shows that transcranial magnetic stimulation (TMS) can improve hand function in people with spinal cord injuries by increasing the brain's ability to send signals to the muscles. This suggests that similar treatments, like MEP Operant Up-conditioning, might also help improve muscle function in spinal cord injury patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Blair Dellenbach, MSOT

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with incomplete spinal cord injury who are over 6 months post-injury, medically stable, and not expecting medication changes for 3 months. They must have weak wrist extension but can still move their arm voluntarily. People with motoneuron injuries, cognitive impairments, seizures, metal in the skull, pregnancy or certain implants cannot join.

Inclusion Criteria

My weaker arm will be the focus if I have weakness in both wrists.

My current medication will not change for the next 3 months.

I have had a spinal cord injury at or above the C6 level.

Exclusion Criteria

I have metal implants in my head.

I have difficulty with memory or thinking clearly.

I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo training of the brain-spinal cord-muscle response using transcranial magnetic stimulation (TMS) to improve wrist extensor muscle function

10 weeks

30 visits (in-person)

Follow-up

Participants are monitored for changes in spasticity, motor function, and muscle strength after completing the training protocol

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MEP Operant Up-conditioning of the Wrist Extensor

Trial Overview The study tests if training the brain-to-muscle pathway using a magnetic stimulator improves arm movement in those with spinal cord injuries. Participants will train their wrist extensor muscle response to this stimulation over 30 visits lasting about 1.5 hours each.

How Is the Trial Designed?

Group I: MEP Wrist Extensor Up-Conditioning Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study involving 11 participants with chronic tetraplegia and 10 neurologically healthy individuals, 10-Hz repetitive transcranial magnetic stimulation (rTMS) combined with repetitive task practice (RTP) significantly improved hand function, particularly in the Jebsen-Taylor Hand Function Test, compared to sham-rTMS.

The results suggest that rTMS may enhance the effectiveness of RTP for improving hand function in individuals with tetraplegia, indicating that higher stimulation doses could lead to even greater improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in hand function in adults with chronic tetraplegia following a multiday 10-Hz repetitive transcranial magnetic stimulation intervention combined with repetitive task practice. Gomes-Osman, J., Field-Fote, EC.[2018]

In a study involving 26 patients with severe spinal cord injuries and 12 control subjects, transcranial magnetic stimulation revealed low-amplitude motor evoked potentials (MEPs) in 4 patients with clinically complete paralysis, suggesting the presence of spared motor pathways.

Neurological reinforcement techniques, such as muscle contractions and cutaneous stimulation, were crucial for detecting MEPs in patients, highlighting their importance in accurately assessing motor function in spinal cord injury studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinforcement of motor evoked potentials in patients with spinal cord injury. Hayes, KC., Allatt, RD., Wolfe, DL., et al.[2007]

In a study involving 97 individuals with spinal cord injury and 20 able-bodied subjects, noninvasive transcranial magnetic stimulation (TMS) revealed that those with motor-incomplete injuries to the cervical or thoracic spinal cord were more likely to have muscle responses in their foot and ankle compared to thigh muscles, indicating better preservation of function in distal lower limb muscles.

The study found that response latencies for lower limb muscles were similar between individuals with cervical or thoracic injuries and able-bodied subjects, suggesting normal motor conduction below the injury site, while those with thoracolumbar injuries showed preserved function in proximal muscles but absent responses in distal muscles, indicating a unique pattern of motor function preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution and latency of muscle responses to transcranial magnetic stimulation of motor cortex after spinal cord injury in humans. Calancie, B., Alexeeva, N., Broton, JG., et al.[2007]

Patients with incomplete spinal cord injury showed higher thresholds for motor evoked potentials and longer latencies in EMG responses to transcranial magnetic stimulation compared to healthy controls, indicating altered motor cortex function.

The longer latency difference between compound motor evoked potentials and suppression of voluntary contraction in patients suggests a potential impairment in cortical inhibition, which may play a role in the recovery of motor function after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses of thenar muscles to transcranial magnetic stimulation of the motor cortex in patients with incomplete spinal cord injury. Davey, NJ., Smith, HC., Wells, E., et al.[2019]

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]

The pilot study found that the paired associative stimulation (PAS) protocol using transcranial magnetic stimulation (TMS) significantly increased corticospinal excitability in both healthy subjects and spinal cord injury (SCI) patients with good motor recovery, suggesting enhanced sensorimotor plasticity.

In contrast, SCI patients with poor functional recovery showed only a non-significant increase in motor-evoked potential (MEP) amplitude, indicating that the ability to induce excitability changes may be linked to the extent of motor recovery after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal cortical neuroplasticity induced by paired associative stimulation after traumatic spinal cord injury: A preliminary study. Versace, V., Langthaler, PB., Höller, Y., et al.[2019]

Citations

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

Improvements in hand function in adults with chronic tetraplegia following a multiday 10-Hz repetitive transcranial magnetic stimulation intervention combined with repetitive task practice. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reinforcement of motor evoked potentials in patients with spinal cord injury. [2007]

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

Distribution and latency of muscle responses to transcranial magnetic stimulation of motor cortex after spinal cord injury in humans. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Responses of thenar muscles to transcranial magnetic stimulation of the motor cortex in patients with incomplete spinal cord injury. [2019]

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

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

6. Ireland pubmed.ncbi.nlm.nih.gov

Abnormal cortical neuroplasticity induced by paired associative stimulation after traumatic spinal cord injury: A preliminary study. [2019]