Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242873
• Other study ID #: IRB00300695
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Shannon M Inches
• Phone: 443-923-9235
• Email: inches[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion 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 AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Gait training with/without TSCS
To assess the safety and impact of paired stimulation and training on gait in children with iSCI, participants will participate in 24 total sessions. Two sessions will involve assessment only and 22 sessions will include two hours of therapy. Sessions will occur at least three times per week, but may be scheduled as many as five times per week. In each session, participants will receive 60 minutes of treadmill training followed by strengthening, segmental task practice, and gait-based interventions. Participants will receive stimulation based on their group assignment (TSCS or sham).

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG)	Measures walking function, balance, and mobility.	session 1, 6, 12, 18, and 24 (5-8 weeks total)
Primary	10-Meter Walk Test (10MWT)	Measures walking speed.	session 1, 6, 12, 18, and 24 (5-8 weeks total)
Primary	Walking Index for Spinal Cord Injury II (WISCI II)	Measures walking quality, including need for assistive device and physical assistance.	session 1, 6, 12, 18, and 24 (5-8 weeks total)
Primary	6-Minute Walk Test (6MWT)	Measures walking endurance	session 1, 6, 12, 18, and 24 (5-8 weeks total)