NCT07438353

Brief Summary

Individuals with chronic cervical spinal cord injury (SCI) and tetraplegia commonly experience persistent impairment in upper limb function, leading to reduced independence and quality of life. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that has demonstrated potential to improve upper limb strength and function when combined with rehabilitation. However, access to tSCS is limited in Singapore due to cost, regulatory barriers, and the need for frequent outpatient therapy. This study evaluates the safety, efficacy, and feasibility of a home-based digital rehabilitation program incorporating tSCS delivered using a commercially available neuromuscular electrical stimulation (NMES) device. Using a prospective, open-label single-case experimental design with multiple baselines across participants, individuals with chronic, non-progressive cervical SCI will receive daily home-based tSCS combined with an mobile application-guided upper limb exercise program. Upper limb function, quality of life, feasibility, and safety outcomes will be assessed longitudinally over a 22-week study period.

Trial Health

63
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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress20%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 15, 2026

Last Update Submit

February 22, 2026

Conditions

Spinal Cord InjuryQuadriplegia/Tetraplegia

Keywords

Transcutaneous spinal cord stimulationTetraplegiaTelerehabilitationRehabilitation TechnologyDigital RehabilitationHome-Based RehabilitationNeuromodulationSpinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Upper limb function

    Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), from a scale of 0 to 3 or 0 to 5, where a higher number indicate better outcome.

    Every 2 weeks for total 22 weeks to collect up to 12 data points

Secondary Outcomes (6)

  • Upper limb strength

    Every 2 weeks for total 22 weeks to collect up to 12 data points

  • Quality of Life (QoL)

    Every 2 weeks for total 22 weeks to collect up to 12 data points

  • Rehabilitation goals achievement

    Before Week 0 and after the end of Week 22

  • Participants and care givers feedback on the appropriateness, acceptability, and feasibility of the programme

    After the end of Week 22

  • Home therapy adherence

    Every 2 weeks for total 22 weeks to collect up to 12 data points

  • +1 more secondary outcomes

Study Arms (3)

Group 1 (intervention at end of Week 4)

OTHER

Intervention begins at the end of week 4 and continues for 18 weeks till week 22

Device: Home-based digital rehabilitation programme with tSCS

Group 2 (intervention at end of Week 10)

OTHER

Intervention begins at the end of week 10 and continues for 12 weeks till week 22

Device: Home-based digital rehabilitation programme with tSCS

Group 3(intervention at end of Week 16)

OTHER

Intervention begins at the end of week 16 and continues for 6 weeks till week 22

Device: Home-based digital rehabilitation programme with tSCS

Interventions

Home-based digital rehabilitation programme with tSCSDEVICE

Home-based digital rehabilitation programme with tSCS introduced at staggered time points following varying duration of baseline usual care

Group 1 (intervention at end of Week 4)Group 2 (intervention at end of Week 10)Group 3(intervention at end of Week 16)

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant
  • Age 21 -75 years;
  • Non-progressive cervical SCI/spinal cord dysfunction (traumatic or non-traumatic);
  • Duration of SCI/spinal cord dysfunction more than or equal to 12 months;
  • ASIA Impairment scale (AIS B, C, or D) with impaired upper limb function;
  • At least one hand capable of grasp and pinch, with or without assistive modification;
  • International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS) more than or equal to 20;
  • Able to maintain an upright sitting position for at least 30 minutes;
  • No contraindication for tSCS (e.g., no pacemakers or other implantable stimulators);
  • Motivated and able to engage in a daily home-based rehabilitation program;
  • Availability of a dedicated care-giver to set up digital home-based therapy program
  • Caregiver
  • Age 21 -75 years;
  • As identified by the patient as the caregiver;
  • Willing to participate in the study

You may not qualify if:

  • Participant
  • Significant or unstable medical co-morbidities including uncontrolled cardiopulmonary disease, severe cognitive impairment, severe dysautonomia, as determined by the investigator;
  • Pregnancy;
  • History of other neurologic conditions affecting upper limb function, such as stroke, multiple sclerosis, or traumatic brain injury;
  • Known history of peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc);
  • Ongoing treatment for cancer;
  • Skin conditions or active cancerous lesion that limit the application of tSCS electrodes
  • Known contraindication for tSCS (pacemakers or other implantable stimulators);
  • Prior exposure to tSCS treatment;
  • Inability to provide informed consent.
  • Caregiver:
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Chen, MD

CONTACT

+6565762049chen.jing@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study design adopts a prospective, open-label study utilizing a single-case experimental design (SCED). Based on this design, a three-tiered, six-phase, multiple-baseline design forms the minimum requirement. Participants will be randomly assigned to any of the three arms with different time of commencement of the intervention. All 3 groups will be on baseline usual care for the first 4 weeks (no specific intervention from this study). A caregiver who will be assisting to administer the home-based program will be recruited alongside each participant.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-01

Locations

SG(1)