Status:
RECRUITING
Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury
Lead Sponsor:
Maria Knikou, PT, MBA, PhD
Conditions:
Spinal Cord Injuries (Complete and Incomplete)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support....
Detailed Description
The main objective of this hypothesis-based and need-driven clinical research trial is to develop novel rehabilitation strategies and impact clinical practice and care for people with spinal cord inju...
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.
- In good general health as evidenced by medical history.
- Diagnosed with incomplete SCI (AIS B, 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.
- The presence of soleus and FCR H-reflexes.
- Absent permanent ankle joint contractures prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat also require 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.
- Neuropathies of the peripheral nervous system.
- Significant degenerative neurological disorders of the spine or spinal cord.
- Diagnosed with AIS A.
- 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, pacemakers, implanted infusion device, and/or implanted stimulators of any type and purpose will be excluded to avoid their malfunction due to stimulation.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07204184
Start Date
October 1 2025
End Date
June 30 2028
Last Update
October 2 2025
Active Locations (1)
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1
College of Staten Island (Building 5N-218)
Staten Island, New York, United States, 10314