What side effects are associated with this type of intervention?

Common treatments for enhancing corticospinal connections and improving motor function in spinal cord injury include transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). Known side effects of tDCS can include mild skin irritation, headache, dizziness, and a tingling sensation at the stimulation site. TMS may cause headaches, scalp discomfort, lightheadedness, and in rare cases, seizures. Both treatments are generally well-tolerated, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically targeting Spike-timing-dependent plasticity (STDP) for enhancing corticospinal connections in spinal cord injury (SCI) patients. However, broader FDA-approved treatments for SCI focus on managing symptoms and complications, such as corticosteroids (e.g., methylprednisolone) to reduce inflammation and secondary damage shortly after injury. Additionally, rehabilitation therapies, including physical and occupational therapy, are commonly used to improve motor function and overall recovery. Research is ongoing to explore advanced neuromodulation techniques and regenerative medicine approaches for SCI treatment.

What other types of research exist?

Promising novel alternatives to STDP for enhancing corticospinal connections and improving motor function in SCI patients include transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). tDCS has shown potential in improving naming accuracy in aphasia patients and is being evaluated for other neurological conditions. TMS, particularly single-pulse TMS, has shown effectiveness in reducing headache days in migraine patients and may offer benefits for motor function recovery in SCI patients.

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Electrical Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Monica Perez, PT PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inclusion criteria for individuals with SCI: Male and females between 18-85 years, Chronic SCI (≥ 6 months post injury), Cervical injury at C8 or above, Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Inclusion criteria for healthy controls: Male and females between 18-85 years, Right handed, Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Must not have

History of seizures

Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from electrical stimulation during electrophysiology assessments and training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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

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I had a condition before my spinal cord injury that made it hard for me to exercise.

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I am taking medication that affects my brain and could make seizures more likely.

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I have had a brain tumor or brain infection in the past.

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I have a spinal condition like stenosis, spina bifida, or a herniated disk.

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I have had a head injury or stroke in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper-limb motor function

Secondary study objectives

Change in Sensorimotor Function

Cortical Neurophysiological Outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Electrophysiology Assessment of Time DomainExperimental Treatment2 Interventions

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

Group II: Electrophysiology Assessment of LocationExperimental Treatment2 Interventions

Assessment of electrophysiology to examine spatial organization of corticospinal function

Group III: Training with some stimulationActive Control1 Intervention

Training with non-invasive stimulation and training with sham stimulation

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Spinal Cord Injury (SCI) focus on enhancing neural pathways and promoting neuroplasticity to improve motor function. Spike-timing-dependent plasticity (STDP) is a promising approach that optimizes the timing of neural signals to strengthen corticospinal connections, which are crucial for motor control. This method aims to maximize the efficacy of residual neural connections, thereby improving motor function in affected limbs. Other treatments include electrical stimulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS), which modulate neural activity to reduce pain and enhance motor recovery. These treatments are vital for SCI patients as they offer potential improvements in mobility and quality of life by leveraging the brain's ability to reorganize and form new neural connections.

Emerging molecular therapeutic targets for spinal cord injury.