Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

ConditionTetraplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Palo Alto Health Care System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

Age 18-65

All gender, any ethnicity

Cervical Spinal Cord Injury C2-8

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: tSCS plus home tele-video supportExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NASA-TLX (NASA Task Load Index)

Measures subjective mental work load \& physical effort

Time frame
At 8 weeks (after completion of home program)
2

QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)

Measures usability of device (eg, adjustability, comfort, safety and effectiveness)

Time frame
At 8 weeks (after completion of home program)

Secondary outcomes

1

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

Measures upper limb sensation, strength, and prehension

Time frame
At entry (Baseline) and repeated at 8 weeks (after completion of home program)
2

CUE-Q (Capabilities of Upper Extremity Function)

Measures functional limitation and difficulty in performing upper limb activities

Time frame
At entry (Baseline) and repeated at 8 weeks (after completion of home program)
3

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

Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations

Time frame
At entry (Baseline) and repeated at 8 weeks (after completion of home program)
4

COPM (Canadian Occupational Performance Measure)

Measures performance \& satisfaction of self-identified activities in self-care, productivity and leisure

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Palo Alto Health Care System

Lead sponsor

ONWARD Medical, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: