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New treatment option for Spinal Cord Injuries
Official title Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
ClinicalTrials.gov ID: NCT06242873
What this study is testing
- What it's testing
- Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 16
You may be able to join if
- Age 3-16
- ≥ 6 months post injury
- Non-progressive SCI
- American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key...
- Neurologic level above T10
You likely can't join if
- Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
- Active wounds
- Range of motion limits impacting gait training
- Cardiac pacemaker/defibrillator
- Active cancer diagnosis
- Absent LE reflexes
See the full eligibility criteria
- Age 3-16
- ≥ 6 months post injury
- Non-progressive SCI
- American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less...
- Neurologic level above T10
- Tolerates upright position for \>30 minutes
- Able to advance one lower extremity (LE) when in standing, bracing and assistive device allowed
- Medically stable (no hospitalizations in last 3 mos.)
- Able to comply with The International Standards for neurological and functional Classification of Spinal Cord Injury (ISNCSCI) exam
- Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
- Active wounds
- Range of motion limits impacting gait training
- Cardiac pacemaker/defibrillator
- Active cancer diagnosis
- Absent LE reflexes
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.