Health TrialsbyHealthPanel

Spinal Neurorehabilitation for Veterans With SCI

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Chronic spinal cord injury (SCI) is a debilitating disorder in Veterans and the broader U.S. population that does not have a cure. Veterans with severe SCI demonstrate permanent loss of sensory and motor function below their injury resulting in decreased quality of life and independence. Recently, electrical spinal neuromodulation has emerged as a potential approach to restore voluntary motor function and locomotion in persons with chronic SCI. However, spinal neuromodulation has yet to translate to clinical use due to small sample sizes in research studies and a lack of information on which patients would benefit. Here, the investigators propose a novel approach to evaluate the priorities and barriers faced by Veterans with SCI to use spinal neuromodulation, understand the neural connections remaining in Veterans with severe SCI, and determine potential functional improvements using non-invasive spinal neuromodulation technology. This research represents the first step towards deploying techniques that could dramatically improve function and quality of life for Veterans with SCI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All participants must be able to independently read and understand study information materials necessary to ensure informed consent

All participants must have a chronic spinal cord injury occurring >1 year prior to study enrollment

Ability to follow simple commands in English

Disqualifiers

Contraindications to the use of external magnetic or electrical stimulation (e.g., epilepsy, intracranial metal, implanted electrosensitive device, etc.)

Significant neurological comorbidities that may affect neurophysiological recordings

Functional disability prior to spinal cord injury

Visual or auditory disorders limiting ability to participate in study procedures

Trial design

Design model

Single group

Treatments tested in this trial

  • Neurophysiological and anatomical testing

    Diagnostic test

    All participants will undergo neurophysiological testing (transcranial magnetic stimulation and somatosensory evoked potentials) to determine residual neural connectivity. All participants will also undergo MRI of the spine to evaluate residual neural connections and changes above and below lesion. These values will be compared to the standard clinical evaluation of spinal cord injury (ISNCSCI exam).

  • Transcutaneous Spinal Stimulation

    Device

    All participants will undergo spinal neuromodulation through non-invasive transcutaneous spinal stimulation to determine the effects on voluntary motor function, sensation, and activities of daily living.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single-armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Axial completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)

Spared region volume at the injury site as assessed by spine MRI will be compared with clinical SCI score as measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam.

Time frame
5 years
2

Sagittal completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)

Intramedullary lesion length will be measured via spine MRI and compared with clinical SCI score as measured by the ISCNSCI exam.

Time frame
5 years
3

Presence of descending connections in chronic spinal cord injury based on transcranial magnetic stimulation

The latency of transcranial magnetic stimulation pulses will be measured via electromyography and compared with clinical SCI score as measured by the ISCNSCI exam.

Time frame
5 years
4

Presence of ascending connections in chronic spinal cord injury based on somatosensory evoked potentials.

The latency of somatosensory evoked potential pulses will be measured via electromyography and compared with clinical SCI score as measured by the ISCNSCI exam.

Time frame
5 years

Secondary outcomes

1

Research priorities of Veteran spinal cord injury stakeholders

The research priorities of Veterans with chronic spinal cord injury will be obtained and compared with previously published results in the non-Veteran population.

Time frame
2 years
2

Voluntary motor function in the presence of non-invasive stimulation

Increases in electromyography will be assessed with and without the use of non-invasive transcutaneous spinal stimulation.

Time frame
5 years
3

Sensory responses in the presence of non-invasive stimulation

Participants will self-report any changes in sensation during the application of non-invasive transcutaneous spinal stimulation.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
Apply now