Cardiovascular Diseases Clinical Trial
— SCIOfficial title:
Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 7-30 days after injury - Injury level =T2 (thoracic level) - American Spinal Injury Association Impairment Scale (AIS) A-C - Exhibits at least one of the following hypotensive symptoms: 1. Baseline hypotension - resting supine or seated SBP < 90mmHg; 2. SBP drop = 20 mmHg within 5 minutes of assuming seated position; 3. Symptoms of orthostasis with a drop of SBP (<90mmHg) from supine to sitting. Exclusion Criteria: - Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection - Ventilator-dependent - History of implanted brain/spine/nerve stimulators - Cardiac pacemaker/defibrillator or intra-cardiac lines - Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction - Initiated on new cardiac medications within the past 5 days - Insufficient mental capacity to understand and independently provide consent - Pregnancy - Cancer - Deemed unsuitable by study physician |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal stimulation sites | Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg). | Through Mapping and testing sessions, average of 2 weeks | |
Primary | Optimal stimulation frequency | Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg). | Through Mapping and testing sessions, average of 2 weeks | |
Primary | Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP | A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation. | Throughout the experiment, average of 2 weeks | |
Primary | Change in Orthostatic symptoms when stimulation is applied | A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation. | Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks | |
Secondary | Numeric Rating Scale (NRS) for pain | Adverse effects will be recorded to assess the safety of stimulation. A numerical scale of 0 to 10 (with 10 meaning the worst pain) will be used to monitor any pain symptoms associated with the stimulation | Throughout the experiment, average of 2 weeks | |
Secondary | Skin integrity assessment | Adverse effects will be recorded to assess the safety of stimulation. Skin integrity (skin irritation or breakdown caused by electrodes, wires or adhesive tape) will be assessed on a daily basis | Throughout the experiment, average of 2 weeks | |
Secondary | Feasibility of applying scTS in inpatient settings - compliance | The ratio of total number of completed sessions divided by the number of sessions initially planned. | Throughout the experiment, average of 2 weeks | |
Secondary | Feasibility of applying scTS in inpatient settings - session duration | The length of time of each session and total length will be recorded. | Throughout the experiment, average of 2 weeks | |
Secondary | Feasibility of applying scTS in inpatient settings - effect on therapy | Total therapy time during inpatient rehabilitation will be recorded to ensure there is no interruption to the normal therapy schedule. | Throughout the experiment, average of 2 weeks | |
Secondary | Electromyography (EMG) of leg muscles - muscle activation (analysis of mean and peak amplitudes) | Analysis of leg-muscle EMG to identify configurations that modulate BP without eliciting motor activity, ensuring that BP response was not due to lower limb muscle contraction | Through Mapping and testing sessions, average of 2 weeks | |
Secondary | Additional hemodynamic measure - diastolic blood pressure | These measures will be collected on a daily basis throughout the trial | throughout the trial, average of 2 weeks | |
Secondary | Additional hemodynamic measure - heart rate | These measures will be collected on a daily basis throughout the trial | throughout the trial, average of 2 weeks |
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