TSCS for Acute SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period
Meet the following Model Systems entry criteria with evidence of BP instability
Exhibit one or more of the following: Resting hypotension - systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females; OH - fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position; BP instability - fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg within a single day during routine activities in the AIR setting.
Have trouble with your blood pressure as determined by your doctor.
Disqualifiers
Implanted brain/spine/nerve stimulators, cochlear implants, cardiac pacemaker/defibrillator, or intracardiac lines
Open skin lesions on or near the electrode placement sites (neck, upper back)
Significant coronary artery or cardiac conduction disease
Recent history of myocardial infarction
Trial design
Design model
Single group
Treatments tested in this trial
TSCS Mapping
Procedure/SurgeryPrior to TSCS Intervention, participants will undergo TSCS Mapping. Electrode location, pulse frequency will be maintained while the stimulation intensity is ramped from 10 to 200 mA. Brachial blood pressures and symptoms will be monitored and recorded at each ramping interval and will continuously monitor and record beat-to-beat heart rate and blood pressures to determine the optimal site and frequency for further TSCS intervention TSCS electrodes will be placed at two vertebral levels in the and back and pulse frequency will be set at 30 to 240 Hz to determine the optimal site and frequency for further TSCS intervention.
Transcutaneous spinal cord stimulation
DeviceTSCS will be used as an adjunct intervention to promote blood pressure stability in conjunction with daily physical and occupational therapy in the inpatient rehabilitation gym. Stimulation will be added to therapy 3-5 times per week as needed for the duration of inpatient hospitalization following SCI. TSCS stimulation will be delivered using Digitimer DS7A, DS8R stimulators and Chattanooga Continuum (DS7A has FDA 510(k) clearance #K051357; Chattanooga Continuum is a Class 2 device).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Acute Inpatients With Spinal Cord InjuryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sit-up Test - Blood Pressure (BP) with and without stimulation.
A brachial BP cuff (Series 400, GE Healthcare, Milwaukee, WI, USA) a finger BP monitor (Finometer ® MIDI Model-2; Finopres Medical Systems BV, Amsterdam, The Netherlands) will be applied. Brachial BP will be monitored at 1-minute intervals for 10-minutes in the supine and 10-minutes in the seated positions.
Time frame
weekly until discharge, average of 3 weeks2
Severity of Dizziness Scale
The severity of orthostatic dizziness will be assessed at 0, 3, 7 and 10 minutes during the seated BP assessment using a scale from 0 to 10, where 0=no dizziness and 10=severe dizziness.
Time frame
weekly until discharge, average of 3 weeks3
Sit-up Test - Heart Rate (HR) with and without stimulation.
A 3-lead electrocardiogram (ECG) (RESP1 Impedance Pneumograph, Moro Bay, CA, USA) will be used to determine HR and to estimate parameters of autonomic cardiac control with the recording electrode in the V5 position (immediately below the left anterior axillary line on the same horizontal plane as the 5th intercostal space).
Time frame
weekly until discharge, average of 3 weeksSecondary outcomes
1
Pain Numeric Rating Scale (NPRS)
Pain scale from 0-10, with higher score indicating more severe pain
Time frame
weekly until discharge, average of 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
James J. Peters Veterans Affairs Medical Center
Collaborator
Source ClinicalTrials.gov