20 Participants Needed

Spinal Cord Stimulation for Spinal Cord Injury

SM
Overseen ByShannon M Inches
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions.Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation.Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation, including transcutaneous methods, is generally considered safe with low rates of complications. For example, a study on cervical spinal cord stimulation found a 0.5% rate of spinal cord injury and low rates of other complications, suggesting it is relatively safe for appropriately selected patients.12345

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for spinal cord injury?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, promoting motor recovery and muscle activation without surgery. Unlike other treatments, tSCS can modulate spinal cord circuitry across multiple segments, potentially enhancing rehabilitation outcomes for individuals with spinal cord injury.16789

What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation for spinal cord injury?

Research shows that Transcutaneous Spinal Cord Stimulation (tSCS) can help improve movement and muscle strength in people with spinal cord injuries by stimulating the spinal cord non-invasively. Studies have reported increased motor responses, such as voluntary movement and muscle activation, in both upper and lower limbs, suggesting it may be a promising therapy for enhancing motor function.167810

Who Is on the Research Team?

RM

Rebecca Martin, OTR/L, OTD, CPAM

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for children with incomplete spinal cord injuries. They will be part of a study to see if gait training combined with Transcutaneous Spinal Cord Stimulation (TSCS) helps improve their walking function compared to just gait training alone.

Inclusion Criteria

My spinal cord injury is above the T10 level.
I am between 3 and 16 years old.
I haven't been hospitalized in the last 3 months.
See 6 more

Exclusion Criteria

Cardiac pacemaker/defibrillator
Pregnancy
I currently have open wounds.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eight weeks of individualized gait training with either TSCS or sham stimulation

8 weeks
Multiple sessions per week

Neurophysiologic Assessment

Determine the neurophysiologic impact of TSCS within a single session using surface EMG and hand-held dynamometry

Single session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Spinal Cord Stimulation
Trial Overview The trial tests the safety and effectiveness of TSCS in kids during an eight-week program. Kids are randomly put into two groups: one gets real TSCS plus walking exercises, and the other gets pretend stimulation (sham) plus the same exercises.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcutaneous Spinal Cord Stimulation and Gait TrainingExperimental Treatment1 Intervention
Group II: Transcutaneous Spinal Cord Stimulation within a single sessionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials
93
Recruited
25,200+

Published Research Related to This Trial

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).
Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury.Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]
Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.
While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review.Megรญa Garcรญa, A., Serrano-Muรฑoz, D., Taylor, J., et al.[2021]
Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.
The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review.Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Citations

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]
Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]
Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]
Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]
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