NCT06140706

Brief 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.

Trial Health

63
Monitor

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
20mo left

Started Sep 2025

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

November 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

November 8, 2023

Last Update Submit

April 7, 2025

Conditions

Tetraplegia

Keywords

paralysisexercisetelemedicinespinal cord stimulationphysical activity

Outcome Measures

Primary Outcomes (2)

  • NASA-TLX (NASA Task Load Index)

    Measures subjective mental work load \& physical effort

    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)

    At 8 weeks (after completion of home program)

Secondary Outcomes (4)

  • GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)

    At entry (Baseline) and repeated at 8 weeks (after completion of home program)

  • CUE-Q (Capabilities of Upper Extremity Function)

    At entry (Baseline) and repeated at 8 weeks (after completion of home program)

  • DASH (Disabilities of the Arm, Shoulder, and Hand)

    At entry (Baseline) and repeated at 8 weeks (after completion of home program)

  • COPM (Canadian Occupational Performance Measure)

    At entry (Baseline) and repeated at 8 weeks (after completion of home program)

Study Arms (1)

tSCS plus home tele-video support

EXPERIMENTAL

Cervical transcutaneous spinal stimulation during home tele-video visits

Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)

Interventions

transcutaneous Spinal Cord Stimulation (tSCS)BEHAVIORAL

Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.

tSCS plus home tele-video support

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

QuadriplegiaParalysisMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jenny Kiratli, PhD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Jaramillo, DPT

CONTACT

650-493-5000jeffrey.jaramillo@va.gov

Jenny Kiratli, PhD

CONTACT

650-493-5000jenny.kiratli@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Health Scientist

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 20, 2023

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)