Home-Based Digital Rehabilitation Program Optimized With Transcutaneous Spinal Cord Stimulation f… (NCT07438353) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home-Based Digital Rehabilitation Program Optimized With Transcutaneous Spinal Cord Stimulation for Upper Limb Functional Enhancement in Tetraplegia (HOPE): A Safety, Efficacy, and Feasibility Study
Singapore9 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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 cance…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Upper limb function
Timeframe: Every 2 weeks for total 22 weeks to collect up to 12 data points