Electrical Stimulation for Spinal Cord Injury

Overseen By Monica Perez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Antipsychotics, Tricyclic antidepressants

Disqualifiers: Pulmonary, Cardiovascular, Orthopedic, others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with spinal cord injuries regain movement in their arms and legs. Researchers examine how the brain's signals can improve muscle responses through electrical stimulation. The trial focuses on activities like reaching and grasping, which are vital for everyday life. It suits individuals who have had a spinal cord injury for at least six months and can move their arms, particularly if the injury is in the neck area (around C8 or above). As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation methods for spinal cord injuries.

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 prior data suggests that these electrophysiological methods are safe for individuals with spinal cord injury?

Research has shown that electrical stimulation methods, like those tested for spinal cord injuries, have the potential to improve movement and health. For example, studies on transcutaneous spinal cord stimulation (tSCS), used with activity-based therapy, have found it safe and effective. Participants in these studies experienced manageable side effects, and the treatment was generally well-received.

Another study on electrical stimulation for spinal injuries found it improved movement and was safe for heart health. Participants were closely monitored, and most found the treatment comfortable. This suggests that the new techniques being tested should be safe for people.

While responses may vary, current research provides a positive outlook on the safety of these treatments for individuals with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to understand and potentially improve spinal cord function. Unlike traditional treatments that may focus on medication or physical therapy, this trial uses electrophysiology to assess the spatial and temporal organization of corticospinal function. By examining how electrical signals travel through the spinal cord, researchers hope to gain insights into more effective rehabilitation techniques. Additionally, the inclusion of training with non-invasive stimulation could offer a novel approach to enhancing recovery, potentially leading to more targeted and effective therapies for spinal cord injury.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that spinal cord stimulation can greatly benefit people with spinal cord injuries. In this trial, participants may undergo various assessments and training. One arm involves the "Electrophysiology Assessment of Time Domain," which examines the temporal organization of corticospinal function. Another arm, "Electrophysiology Assessment of Location," focuses on the spatial organization of corticospinal function. Additionally, some participants will receive "Training with some stimulation," which includes non-invasive stimulation and training with sham stimulation. Previous studies found that 72% of participants experienced significant improvements in using their arms and hands after receiving non-invasive electrical stimulation. Another study found that combining spinal cord stimulation with activity-based exercises improved function, especially after many sessions. These results suggest that electrical stimulation can strengthen remaining nerve pathways, leading to better movement and daily activity performance. Overall, training with stimulation appears promising for aiding recovery in spinal cord injury cases. ^{2 6 7 8 9}

Who Is on the Research Team?

Monica Perez, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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.

Premorbid, ongoing major depression or psychosis, altered cognitive status

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Electrophysiology Assessment of Location
• Electrophysiology Assessment of Time Domain
• Training with some stimulation

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.

How Is the Trial Designed?

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+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ... Spinal cord stimulation alone led to significant pain reductions, with responder rates above 80% and average decreases of 5–6 cm on pain scales.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01636-6

Activity-based recovery training with spinal cord epidural ... This cohort study aimed to assess the effects of stand-ABRT with scES in individuals with cervical chronic spinal cord injury.

5. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... Of the 60 participants included in the primary effectiveness endpoint analysis, 43 (72%) met or exceeded the minimally important difference ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... Epidural spinal cord stimulation (eSCS) has demonstrated promising results in promoting recovery of motor and autonomic function in individuals ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10179213/

Electrical Stimulation Exercise for People with Spinal Cord Injury Electrical stimulation exercise has become an important modality to help improve the mobility and health of individuals with spinal cord injury (SCI).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03975634

Transcutaneous Spinal Stimulation: Safety and Feasibility ... We will monitor the participants throughout the testing and training for their response to the stimulation (i.e. safety) and their comfort. Detailed Description.

9. mdpi.com mdpi.com/2227-9067/12/7/817

Cumulative Transcutaneous Spinal Stimulation with ... This pilot study evaluated the safety, feasibility, and cumulative effects of AB-LT combined with scTS on trunk control in children with SCI.