Health TrialsbyHealthPanel

Epidural Stimulation and Resistance Training After SCI

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUnited States Department of Defense

About this trial

Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam.

Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.

All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included.

Disqualifiers

Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia;

Unhealed fracture in either lower or upper extremities;

Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees.

Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exoskeletal assisted walking

    Device

    Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.

  • Epidural Stimulation

    Device

    lumbo-sacral epidural simulation at the beginning of the study.

  • Resistance Training

    Procedure/Surgery

    Using two forms of resistance training to increase muscle size. The first form includes seated leg extension exercise for 12 weeks followed by a second form that includes sit-to-stand exercise using participant's body weight.

  • delayed-ES

    Device

    lumbo-sacral epidural simulation starting 6 months after the beginning of the study.

  • no-Resistance training

    Procedure/Surgery

    The participants will perform 24 weeks of passive movement or passive stretching from seated position.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: EAW+ES+RTExperimental treatment 3 interventions
Group B: EAW+ delayed-ES +no-RTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in 10-meter over ground walking-speed

The investigators will measure the speed of walking and the time elapsed during 10 meter distance.

Time frame
Baseline to 12 months
2

Change in EMG Pattern

The investigators will record muscle activity from the major lower extremity muscle groups.

Time frame
Baseline to 12 months

Secondary outcomes

1

Changes in Systolic and Diastolic Blood Pressure

The investigators will measure resting and walking blood pressure on continuous basis

Time frame
Baseline to 12 months
2

Changes in regional fat mass

body composition will be measured using dual energy x-ray absorptiometry

Time frame
Baseline to 12 months
3

Change in Oxygen uptake

measuring whole oxygen uptake during 6-minute walking test

Time frame
baseline and every 6 months for 12 months

Other outcomes

1

Changes in Bladder Filling and Emptying using Fluoroscopy and EMG

The investigators will determine the impact of 12 months intervention on parameters of bladder filling and emptying as measured by urodynamic studies.

Time frame
Baseline to 12 months

Sponsors and contacts

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United States Department of Defense

Lead sponsor

Virginia Commonwealth University

Sponsor institution

Central Virginia VA Health Care System

Collaborator

Source ClinicalTrials.gov
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