Status:
COMPLETED
Transspinal Stimulation Plus Locomotor Training for SCI
Lead Sponsor:
City University of New York
Collaborating Sponsors:
Bronx Veterans Medical Research Foundation, Inc
Icahn School of Medicine at Mount Sinai
Conditions:
Spinal Cord Injuries
Paraplegia, Spinal
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmen...
Detailed Description
Spinal cord injury (SCI) greatly impairs standing and walking ability, which severely compromises daily living activities. While these deficits are partially improved by locomotor training, even after...
Eligibility Criteria
Inclusion
- Willingness to comply with all study procedures and availability for the duration of the study.
- Ability to understand the consent form, and sign the consent form.
- Male or female, age 18-70 years old.
- In good general health as evidenced by medical history.
- Diagnosed with motor incomplete SCI (AIS C-D).
- Bone mineral density of the hip (proximal femur) T-score \<3.5 SD from age- and gender-matched normative data.
- Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion.
- Presence of tendon reflexes to be able to elicit the soleus H-reflex.
- Absent permanent ankle joint contractures that prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat require also flexible ankle joints.
- A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology.
- Time after SCI of more than 6 months.
- Stable medical condition without cardiopulmonary disease or cognitive impairment.
Exclusion
- Supraspinal lesions.
- Significant neuropathies of the peripheral nervous system.
- Significant degenerative neurological disorders of the spine or spinal cord.
- AIS A or B.
- Presence of pressure sores.
- Advanced urinary tract infection.
- Neoplastic or vascular disorders of the spine or spinal cord.
- Participation in an ongoing research study or new rehabilitation program.
- Pregnant women or women who suspect they may be, or may become pregnant will be excluded from participation because the risks of thoracolumbar stimulation to the fetus are unknown.
- People with cochlear implants, pacemaker, implanted infusion device, and/or implanted stimulators of any type and purpose will be excluded to avoid their malfunction due to stimulation.
- People with history of seizures.
- Medical conditions that increase the possibility of seizures.
- Medications that may change the seizure threshold.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04807764
Start Date
August 1 2021
End Date
December 31 2024
Last Update
March 11 2025
Active Locations (2)
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1
Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
Staten Island, New York, United States, 10314
2
Veterans Affairs Medical Center
The Bronx, New York, United States, 10468