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Transspinal Stimulation + Locomotor Training for Spinal Cord Injury

N/A

Recruiting

Led By Maria Knikou, PT, PhD

Research Sponsored by City University of New York

Eligibility Criteria Checklist

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

Must have

Male or female, age 18-70 years old

Bone mineral density of the hip (proximal femur) T-score <3.5 SD from age- and gender-matched normative data

Must not have

People with history of seizures

Medical conditions that increase the possibility of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Summary

This trial will test the effects of adding electrical stimulation to locomotor training to help improve walking ability in people with Spinal Cord Injury.

Who is the study for?

This trial is for adults aged 18-70 with motor-incomplete spinal cord injury (SCI) above the T10 level, who can sign consent and commit to the study duration. They must be in good health, have a bone mineral density T-score <3.5 SD from norms, reflexes present for soleus H-reflex testing, flexible ankle joints without contractures, first-time SCI due to trauma or similar causes, and at least 6 months post-SCI.

What is being tested?

The study tests if high-frequency noninvasive thoracolumbar spinal stimulation before locomotor training improves walking ability in people with incomplete SCI. Participants will receive either real or sham stimulation while lying down or standing before robotic gait training over 40 sessions.

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation and fatigue from locomotor training. There's also a risk of seizures for those predisposed; however specific risks related to this intervention are not detailed.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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My hip bone density is much lower than normal for my age and gender.

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My spinal injury is above the T10 level.

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I have a spinal cord injury that allows for some movement.

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My spinal injury is above the middle of my back.

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My ankles can move freely without stiffness.

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I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.

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My heart, lungs, and mind are in stable condition.

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I have a spinal cord injury for the first time due to an accident, blood flow issue, or bone problem.

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I have a spinal cord injury that allows me some movement.

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My ankles can move freely without stiffness.

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 have a medical condition that could cause seizures.

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I have a serious spine or spinal cord condition.

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I have pressure sores.

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I have lesions above my spinal cord.

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I have severe nerve pain or numbness.

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My spinal cord injury is classified as complete or sensory incomplete.

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I have a severe urinary tract infection.

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I have a tumor or blood vessel disorder in my spine or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Plasticity of corticospinal networks

Plasticity of spinal neuronal networks

Secondary study objectives

Ambulatory function

Autonomic function

Balance

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Real transspinal stimulation delivered while lying supine followed by locomotor trainingExperimental Treatment1 Intervention

Transspinal tonic stimulation will be delivered at a frequency of 30 Hz while lying supine.

Group II: Real transspinal stimulation delivered during standing followed by locomotor trainingExperimental Treatment1 Intervention

Transspinal tonic stimulation of the thoracolumbar region will be delivered at a frequency of 30 Hz during standing with as needed body weight support (BWS) in a standing frame or in the Lokomat to ensure safety.

Group III: Sham transspinal stimulation delivered during standing followed by locomotor trainingPlacebo Group1 Intervention

One sham group will be receiving transspinal stimulation during standing at an intensity where sensation is absent.

0 / 20Eligibility criteria met