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Neurostimulation Device

Spinal Cord Stimulation for Quadriplegia

N/A

Recruiting

Led By Monica A Perez, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Male and female Veterans between 18-70 years with chronic SCI (1 year of injury)

Chronic SCI (1 year of injury)

Must not have

Receiving drugs acting primarily on the central nervous system lowering the seizure threshold

History of head injury or concussion, skull fractures, unexplained headaches in the last 6 months, or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion(average of 5 weeks) and during 6-month follow-up

Summary

This trial will examine the effects of TESS on upper-limb muscles after cervical SCI, with the goal of increasing reaching and grasping potential.

Who is the study for?

This trial is for male and female Veterans aged 18-70 with chronic spinal cord injury (SCI) at least one year old, specifically those who can grip with one hand and have a cervical injury above C8. Participants must not be pregnant, have debilitating diseases or major depression/psychosis, head injuries, uncontrolled medical issues, metal in the skull, history of seizures or drugs that lower seizure threshold.

What is being tested?

The study tests TESS (transcutaneous electrical spinal stimulation), combined with motor training tasks to improve upper-limb function after SCI. It compares the effects of actual TESS versus sham (fake) treatment on muscle behavior and recovery potential in reaching/grasping movements.

What are the potential side effects?

While specific side effects are not listed here, similar studies suggest possible skin irritation from electrodes, discomfort from electrical stimulation or muscle fatigue during training sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am a Veteran aged 18-70 with a spinal cord injury for over a year.

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I have had a spinal cord injury for over a year.

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I can visibly squeeze my hand into a fist.

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I can grasp objects with at least a minimal grip.

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I have normal or altered sensation in my upper limbs.

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My MRI shows damage in my neck at C8 or above.

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I am a Veteran aged between 18 and 70.

Exclusion Criteria

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

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I am taking medication that could increase my risk of seizures.

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I have had a head injury, concussion, skull fracture, unexplained headaches in the last 6 months, or a stroke.

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I have a history of seizures.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion(average of 5 weeks) and during 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion(average of 5 weeks) and during 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion(average of 5 weeks) and during 6-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in GRASSP Test

Changes in amplitude of Motor evoked potential size

Changes in amplitude of cervicomedullary motor evoked potential size

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active TESS + TrainingActive Control3 Interventions

Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: \[1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping \& reaching + training.\] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Group II: Active TESS Group 1Active Control3 Interventions

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Group III: Sham TESS Group 1Placebo Group3 Interventions

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

0 / 13Eligibility criteria met