TetraplegiaNCT06140706
Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI
A study testing transcutaneous Spinal Cord Stimulation (tSCS) in people with Tetraplegia, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- transcutaneous Spinal Cord Stimulation (tSCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Age 18-65
- All gender, any ethnicity
- Cervical Spinal Cord Injury C2-8
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
- GRASSP-Prehension Score >10 or GRASSP Strength Score >30
Show all 10Show fewer
- Greater than 1 year post injury
- Able to identify a companion to assist with neurostimulator setup in home environment.
- Internet connection to support video telehealth connection
- Willingness to travel to the VA Palo Alto Medical Center
Who cannot join
- Cardiopulmonary disease or cardiac symptoms,
- Autonomic dysreflexia that is uncontrolled or severe,
- Implanted medical device(s),
- Uncontrolled spasms that could limit participation in exercise training,
- Skin breakdown or active pressure injury in areas of electrode placement.
- Participants must not be engaged in any concurrent drug or device trial
- Pregnant, are planning to become pregnant, or breastfeeding
- The study is not deemed safe or appropriate in the opinion of the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
Read the detailed description
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.
The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.
- Conditions
- Tetraplegia
- Being tested
- transcutaneous Spinal Cord Stimulation (tSCS)
- Keywords
- paralysis, exercise, telemedicine, spinal cord stimulation, physical activity
- Medical subject headings
- Quadriplegia, Paralysis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous Spinal Cord Stimulation (tSCS)Behavioural
Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.
| Study group | Role | What they receive |
|---|---|---|
| tSCS plus home tele-video support | Experimental | Cervical transcutaneous spinal stimulation during home tele-video visits Receives: Behavioral: transcutaneous Spinal Cord Stimulation (tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASA-TLX (NASA Task Load Index)
Measures subjective mental work load \& physical effort
Measured: At 8 weeks (after completion of home program)
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)
Measures usability of device (eg, adjustability, comfort, safety and effectiveness)
Measured: At 8 weeks (after completion of home program)
Secondary outcomes (4)
GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)
Measures upper limb sensation, strength, and prehension
Measured: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
CUE-Q (Capabilities of Upper Extremity Function)
Measures functional limitation and difficulty in performing upper limb activities
Measured: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
DASH (Disabilities of the Arm, Shoulder, and Hand)
Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations
Measured: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
COPM (Canadian Occupational Performance Measure)
Measures performance \& satisfaction of self-identified activities in self-care, productivity and leisure
Measured: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- ONWARD Medical, Inc.
- Responsible party
- Principal investigator, Beatrice Jenny Kiratli PhD, VA Palo Alto Health Care System
- Investigators
- Jenny Kiratli, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140706
- Sponsor's protocol ID
- IRB-68905
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
- ClinicalTrials.gov ID
- NCT06140706
- Acronym / sponsor ID
- IRB-68905
- Conditions
- Tetraplegia
- Keywords
- paralysis, exercise, telemedicine, spinal cord stimulation, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- ONWARD Medical, Inc.
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
Detailed description
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.
The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tSCS plus home tele-video support | Experimental | Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)Cervical transcutaneous spinal stimulation during home tele-video visits |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veteran
- Age 18-65
- All gender, any ethnicity
- Cervical Spinal Cord Injury C2-8
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
Key exclusion criteria (8 listed)
- Cardiopulmonary disease or cardiac symptoms,
- Autonomic dysreflexia that is uncontrolled or severe,
- Implanted medical device(s),
- Uncontrolled spasms that could limit participation in exercise training,
- Skin breakdown or active pressure injury in areas of electrode placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous Spinal Cord Stimulation (tSCS)Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement. | Behavioural | tSCS plus home tele-video support |
Primary outcome
NASA-TLX (NASA Task Load Index)
Time frame: At 8 weeks (after completion of home program)
Measures subjective mental work load \& physical effort
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)
Time frame: At 8 weeks (after completion of home program)
Measures usability of device (eg, adjustability, comfort, safety and effectiveness)
4 secondary outcomes
GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)
Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
CUE-Q (Capabilities of Upper Extremity Function)
Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
DASH (Disabilities of the Arm, Shoulder, and Hand)
Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
COPM (Canadian Occupational Performance Measure)
Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Kiratli, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous Spinal Cord Stimulation (tSCS) in people with Tetraplegia, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Jaramillo, DPT (650-493-5000 ext. 62286, jeffrey.jaramillo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NASA-TLX (NASA Task Load Index) (time frame: At 8 weeks (after completion of home program)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.