Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT04032990|
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Biostim-5 transcutaneous spinal stimulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Transcutaneous spinal stimulation - Acute and Training
Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects.
Device: Biostim-5 transcutaneous spinal stimulator
Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury
- Incidence of skin irritation [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]Skin color, particularly change in skin color to pink indicating irritation in the location of the stimulating electrode placement will be assessed prior to stimulation experiments and immediately after; incidence of pink- or redness or irritation and time (minutes-days) to dissipation will be recorded.
- Faces Pain Scale-Revised (scale 0-10) [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]Faces Pain Scale - Revised is a self-report measure of pain intensity developed for children (C.L. Hicks et al. Pain 93 (2001). It will be used to score the sensation of pain on 0 (min - no pain)-to-10 (max - worst pain ever) metric. The scale depicts 6 facial expressions: first - face with a neutral expression corresponds to pain score of 0, next facial expression is scored as 2, etc. The faces scale will be presented to the participant (ages 3-8) prior to the experiment for baseline measurement, during stimulation and following the experiment.
- Visual Analog Scale (0-10) [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]To assess pain in the participants ages 8 and above, Visual Analog Scale (self-reported measure) will be presented with 0 corresponding to no pain and 10 corresponding to the "worst pain ever"; the scale will be presented at baseline measurement, during stimulation and following the experiment.
- Blood pressure [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
continuous beat-by-beat blood pressure (mmHg) recordings will be made using Finapres finger cuff system for 5 minutes prior to and 5 minutes immediately following stimulation while the child is sitting; Brachial arm blood pressure will be periodically measured during stimulation (mmHg).
systolic and diastolic blood pressure values will be compared with the established norms for typically developing children (age and height matched);
- Number of requests to stop the stimulation [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]Number of participants requesting (or number of request per participant within experimental sessions) to stop stimulation due to pain, fatigue or any other reason (documented)
- Angular excursions of upper extremity and hand [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]degrees of flexion/extension, adduction/abduction in elbow, shoulder, wrist, fingers
- Hand Grip strength [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]A hand grip strength dynamometer will be used to assess strength (Newton)
- Heart Rate [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]heart rate (beats per minute) will be continuously monitored and recorded using 3-lead electrocardiogram.
- Compliance rate [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]Compliance - number of sessions missed and reason, willingness to continue participation.
- Angular excursions of trunk during trunk control assessments [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]trunk kinematics (degrees of flexion/extension) in cervical, thoracic and lumbar regions;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032990
|Contact: Lisa Clayton, B.S.||502-333-8152||LisaClayton@KentuckyOneHealth.org|
|United States, Kentucky|
|Department of Neurosurgery||Not yet recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Lisa Clayton, BS 502-333-8152 LisaClayton@KentuckyOneHealth.org|
|Principal Investigator:||Andrea L Behrman, PT, PhD||University of Louisville|