300 Participants Needed

Electrical Stimulation for Spinal Cord Injury

Monica Perez, PhD profile photo
Overseen ByMonica Perez, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.1691011

Who Is on the Research Team?

Richard L. Lieber, PhD

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.
I do not have unmanaged lung, heart, or bone problems.
See 8 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Electrophysiology Assessment of Time DomainExperimental Treatment2 Interventions
Group II: Electrophysiology Assessment of LocationExperimental Treatment2 Interventions
Group III: Training with some stimulationActive Control1 Intervention

Find a Clinic Near You

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

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

Citations

Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review. [2020]
[Prognosis of traumatic spinal cord lesions. Significance of clinical and electrophysiological findings]. [2019]
[Neurological diagnosis and prognosis: significance of neurophysiological findings in traumatic spinal cord lesions]. [2006]
Upper Limb Recovery in Spinal Cord Injury: Involvement of Central and Peripheral Motor Pathways. [2017]
Electrophysiological evaluation of root and spinal cord disease. [2005]
Compensation for injury potential by electrical stimulation after acute spinal cord injury in rat. [2020]
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]
Electrophysiological evaluation of the patient with acute spinal cord injury. [2005]
Characterization of graded multicenter animal spinal cord injury study contusion spinal cord injury using somatosensory-evoked potentials. [2021]
Spinal cord stimulation as a tool for physiological research. [2019]
11.United Statespubmed.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]
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