Electrical Stimulation for Spinal Cord Injury

Overseen by Monica Perez, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Antipsychotics, Tricyclic antidepressants

Disqualifiers: Pulmonary, Cardiovascular, Orthopedic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses electrical stimulation techniques to help patients with partial spinal cord injuries improve their arm and hand movements. The treatment works by enhancing the timing and coordination of nerve signals, making it easier for the brain and spinal cord to control muscles. Electrical stimulation of the spinal cord has been practiced as a therapy by the medical community for a long time.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that affect the central nervous system and lower the seizure threshold, such as certain antipsychotic drugs and tricyclic antidepressants.

What data supports the effectiveness of the treatment 'Electrical Stimulation for Spinal Cord Injury'?

Electrophysiological techniques, which are part of the treatment, can help predict functional outcomes in spinal cord injury patients, such as walking ability and hand function, by assessing nerve responses. These techniques are valuable in planning rehabilitation and selecting appropriate therapies, suggesting they may support recovery when used as part of a treatment plan. ^{1 2 3 4 5}

Is electrical stimulation for spinal cord injury generally safe in humans?

The research does not provide specific safety data for electrical stimulation in humans, but it discusses various electrophysiological methods used in spinal cord injury trials, which are generally considered safe for monitoring purposes. ^{1 6 7 8 9}

How does electrical stimulation differ from other treatments for spinal cord injury?

Electrical stimulation for spinal cord injury is unique because it uses electrical currents to activate the spinal cord's neural circuits, potentially restoring motor functions even after paralysis. Unlike other treatments, it involves implanting electrodes to target specific spinal cord regions, enabling intentional control of movements, which is not typically possible with standard therapies. ^{1 2 6 10 11}

Research Team

Monica Perez, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

This trial is for adults aged 18-85 with chronic spinal cord injury (SCI) at C8 or above, who can still perform certain reach and grasp movements. It's also open to right-handed healthy controls without SCI but with similar abilities. Pregnant women, individuals with metal in the skull, seizure history, severe medical issues, depression/psychosis, head injury/stroke history, pacemakers or those on specific CNS drugs are excluded.

Inclusion Criteria

I am between 18-85 years old, right-handed, and can reach and grasp objects without leaning forward.

I am between 18-85 years old with a spinal cord injury at C8 or above, and can still move my hands.

Exclusion Criteria

Pacemaker

I have a history of seizures.

I do not have unmanaged lung, heart, or bone problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Electrophysiology Assessment

Assessment of electrophysiology in the time and spatial domains to examine corticospinal function

5 months

Training with Stimulation

Training with non-invasive stimulation and sham stimulation to promote recovery of function

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Electrophysiology Assessment of Location (Other)
• Electrophysiology Assessment of Time Domain (Corticosteroid)
• Training with some stimulation (Other)

Trial Overview The study aims to improve motor function in people with SCI using advanced electrophysiological methods to test corticospinal connections. Participants will undergo assessments of muscle response timing and location plus training that includes some form of stimulation focused on enhancing reach and grasp movements.

Participant Groups

Group I: Electrophysiology Assessment of Time Domain Experimental Treatment 2 Interventions

Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function

Group II: Electrophysiology Assessment of Location Experimental Treatment 2 Interventions

Assessment of electrophysiology to examine spatial organization of corticospinal function

Group III: Training with some stimulation Active Control 1 Intervention

Training with non-invasive stimulation and training with sham stimulation

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Dr. Pablo Celnik

Shirley Ryan AbilityLab

Chief Executive Officer since 2023

MD from University of Buenos Aires Faculty of Medical Sciences

Dr. James Sliwa

Shirley Ryan AbilityLab

Chief Medical Officer since 2021

DO

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Findings from Research

A systematic review of 64 clinical trials on spinal cord injury revealed that electrophysiological measures, such as electromyography and motor evoked potentials, are commonly used to assess neural function, highlighting their importance in clinical research.

The review identified significant variability in how these electrophysiological outcomes are measured and reported, indicating a critical need for standardized reporting guidelines to improve comparability and optimization of treatments in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review. Korupolu, R., Stampas, A., Singh, M., et al.[2020]

Electrophysiological techniques, such as somatosensory-evoked potentials (SSEP) and motor-evoked potentials (MEP), provide reliable assessments of spinal cord injury severity and prognosis, even in uncooperative patients, which is crucial for early intervention.

These techniques can predict functional outcomes like ambulatory capacity and bladder function, aiding in the planning of rehabilitation therapies such as functional electrical stimulation and botulinum toxin application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prognosis of traumatic spinal cord lesions. Significance of clinical and electrophysiological findings]. Curt, A., Dietz, V.[2019]

Electrophysiological techniques like somatosensory evoked potentials (SSEP) and motor evoked potentials (MEP) provide critical insights into the extent and severity of spinal cord injuries, especially in uncooperative patients, allowing for early prognosis of functional deficits.

These techniques can predict specific outcomes such as ambulatory capacity and bladder function based on nerve recordings, which aids in planning effective rehabilitation therapies for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neurological diagnosis and prognosis: significance of neurophysiological findings in traumatic spinal cord lesions]. Curt, A.[2006]

In a study of 305 patients with cervical spinal cord injury, electrophysiological measures like MEPs and CMAPs showed that motor recovery is linked to the severity of initial sensorimotor impairment, with improvements observed within the first 6 months post-injury.

The findings suggest that monitoring neurophysiological parameters can provide valuable insights into motor recovery and may enhance the effectiveness of interventional studies, highlighting the importance of both central and peripheral motor pathways in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Limb Recovery in Spinal Cord Injury: Involvement of Central and Peripheral Motor Pathways. Petersen, JA., Spiess, M., Curt, A., et al.[2017]

Electrophysiological evaluations are crucial for assessing functional integrity in patients with root or spinal cord diseases, offering insights that complement neuroimaging studies.

Different electrophysiological techniques provide varied information about lesions and underlying physiological mechanisms, highlighting the need for a tailored approach based on the specific clinical problem being addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of root and spinal cord disease. Aminoff, MJ.[2005]

The study highlights the significance of injury potential in spinal cord injuries and introduces a method to adjust electrical stimulation intensity based on this potential, which was tested on rats after injury.

Results indicate that electrical stimulation can lead to higher injury potentials compared to non-stimulated rats, suggesting that stimulation may aid in membrane repair during the recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensation for injury potential by electrical stimulation after acute spinal cord injury in rat. Zhang, G., Wang, A., Zhang, C., et al.[2020]

Using brain tissue from adult rats and non-human primates, researchers demonstrated that in vitro electrophysiology can effectively characterize AMPAR synaptic and single channel currents, providing insights into drug effects without relying solely on animal testing.

The study found that both species exhibited similar and distinct responses to the AMPAR modulator LY451395, suggesting that adult animal models can enhance the understanding of drug-induced CNS effects and improve safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system. Miraucourt, LS., Accardi, MV., Asin, KE., et al.[2021]

Electrophysiologic monitoring, including techniques like somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs), is crucial for assessing spinal cord injuries and can provide valuable insights into the extent of nerve damage.

The article compiles detailed reports on SEP recordings in spinal cord injury cases, highlighting the importance of these measurements in clinical applications and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of the patient with acute spinal cord injury. Grundy, BL., Friedman, W.[2005]

Electrophysiological analysis using somatosensory-evoked potentials (SEPs) provides a more objective and sensitive measure of spinal cord injury severity and recovery compared to the Basso, Beattie, Bresnahan (BBB) scale, particularly in milder injuries.

In a study involving Fischer rats with graded contusion spinal cord injuries, SEPs showed significant differences in recovery patterns that were not as easily detected by BBB scores, highlighting the importance of using both methods for evaluating therapeutic interventions in spinal cord injury research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of graded multicenter animal spinal cord injury study contusion spinal cord injury using somatosensory-evoked potentials. Agrawal, G., Kerr, C., Thakor, NV., et al.[2021]

Spinal cord stimulation can help alleviate disabilities caused by motor neuron lesions, and it allows researchers to measure spinal cord physiology in new ways.

Using externalized leads for epidural electrodes enables the recording of spinal cord activity and responses, which can improve the understanding of motor disabilities and enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation as a tool for physiological research. Dimitrijevic, MR., Faganel, J., Sherwood, AM.[2019]

Epidural electrical stimulation (EES) has shown promise in restoring motor functions in two human subjects with complete paralysis due to spinal cord injury, enabling intentional control of step-like activity within just five days after implantation.

The study highlights the effectiveness of using EES-evoked motor responses to guide the precise positioning of electrode arrays during surgery, ensuring stable and targeted stimulation of spinal cord regions associated with lower limb movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. Calvert, JS., Grahn, PJ., Strommen, JA., et al.[2020]

References

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

Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Prognosis of traumatic spinal cord lesions. Significance of clinical and electrophysiological findings]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Neurological diagnosis and prognosis: significance of neurophysiological findings in traumatic spinal cord lesions]. [2006]

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

Upper Limb Recovery in Spinal Cord Injury: Involvement of Central and Peripheral Motor Pathways. [2017]

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

Electrophysiological evaluation of root and spinal cord disease. [2005]

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

Compensation for injury potential by electrical stimulation after acute spinal cord injury in rat. [2020]

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

The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system. [2021]

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

Electrophysiological evaluation of the patient with acute spinal cord injury. [2005]

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

Characterization of graded multicenter animal spinal cord injury study contusion spinal cord injury using somatosensory-evoked potentials. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation as a tool for physiological research. [2019]

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

Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. [2020]