NCT06489106

Brief Summary

The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

June 27, 2024

Last Update Submit

February 13, 2026

Conditions

Spinal Cord Injury Cervical

Keywords

Pediatric onsetTranscutaneous spinal cord stimulationHand and arm functionChronic spinal cord injury

Outcome Measures

Primary Outcomes (2)

  • Hand grip

    Voluntary maximal hand grip force

    12 weeks

  • Hand control

    Peak to peak distance on hand grip force

    12 weeks

Secondary Outcomes (4)

  • Functional neurophysiological assessment-Upper extremity

    12 weeks

  • Pediatric Neurorecovery scale

    12 weeks

  • Capabilities of upper extremity test

    12 weeks

  • Box and block test

    12 weeks

Study Arms (2)

Activity based upper extremity training

ACTIVE COMPARATOR

Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session.

Device: Activity based upper extremity training with and without stimulation

Activity based upper extremity training with stimulation

EXPERIMENTAL

Activity-based upper extremity training (AB-UET + scTS) will be administered 5d/week and 1 hour 30 minutes/session. UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of \~ 10 minute/bouts.

Device: Activity based upper extremity training with and without stimulation

Interventions

Activity based upper extremity training with and without stimulationDEVICE

Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session. For AB-UET+ stimulation (scTS), UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of \~ 10 minute/bouts.

Activity based upper extremity trainingActivity based upper extremity training with stimulation

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • For aim 1 and 2, 10 participants with SCI:
  • age 7-12 years;
  • chronic (\>6 months), acquired upper motor neuron SCI;
  • cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
  • Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
  • For Aim 3, 4 participants with SCI who:
  • complete aim 1 and 2;
  • consent/assent for aim 3
  • demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
  • confirmed volitional activation in hand muscles during hang grip assessment without scTS

You may not qualify if:

  • For all 3 aims will include:
  • Botox use within past 3 months (for upper or lower extremity);
  • current oral baclofen (or pump);
  • musculoskeletal impairment limiting range of motion;
  • unhealed fracture or other medical condition limiting participation in AB-UET;
  • etiology of spina bifida;
  • total ventilator dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kentucky Spinal Cord Injury Research Center

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Goutam Singh, PhD

    University of Louisville and Spalding University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

June 13, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

US(1)