Clinical trial NCT05982171: Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
Official title: Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas:

* walking ability and speed
* lower extremity strength, activation, and spasticity
* trunk control
* bowel and bladder function


Eligibility criteria: Inclusion Criteria:

* \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
* AIS C or D classification
* 18 years and older
* Height 5'0" to 6'4"
* Weight 220lbs or less
* Sufficient upper extremity strength to manage a stability aide
* Medical clearance for high intensity gait training
* Walking \<1.46 m/s
* Intact skin in on pelvis, lower extremities and back
* Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits

Exclusion Criteria:

* Unstable or symptomatic cardiac or respiratory issues
* Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study
* Received Botox injections to the lower extremities within the last six months
* Pregnancy
* Cauda Equina injury
* Any other issue that in the opinion of the investigator would impact study participation
* Non-English Speaking

Primary outcomes:
measure: Change in score on Walking Index for SCI (WISCI) II
timeFrame: Baseline to Immediately After Intervention
Secondary outcomes:
measure: Change in walking speed as measured by the 10 Meter Walk Test
timeFrame: Baseline to Immediately After Intervention
measure: Change in distance walked as measured by the 6 Meter Walk Test
timeFrame: Baseline to Immediately After Intervention
measure: Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)
timeFrame: Baseline to Post-treatment
measure: Change in spasm frequency and severity as measured by Penn Spasm Frequency
timeFrame: Baseline to Immediately After Intervention
measure: Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale
timeFrame: Baseline to Immediately After Intervention
measure: Change in bladder function as measured by Neurogenic Bladder Symptom Scale
timeFrame: Baseline to Immediately After Intervention
measure: Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury
timeFrame: Baseline to Immediately After Intervention
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: