Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

Cardiovascular Diseases Clinical Trial

— SCI  

Official title:

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731986
• Other study ID #: CSCR23FEL002
• Secondary ID: CSCR23FEL002
• Status: Recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: Kessler Foundation
• Contact: LeighAnn Martinez, BA
• Phone: (973)324-3557
• Email: lmartinez[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Blood pressure (BP) control in persons with a spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Cardiovascular (CV) dysfunction develops early after SCI and often continues a lifetime. Orthostatic hypotension (OH), a 20/10 mmHg decrease in systolic/diastolic BP when moving from a supine to an upright position, is especially prevalent in the early phase, and frequently accompanied by symptoms of dizziness, weakness, fatigue, and syncope. Affecting up to 75% of therapy treatments during inpatient rehabilitation, OH significantly interferes with participation during the critical rehab time-period, especially as length of stay in rehabilitation has substantially shortened in the past decades.

The compelling rationale for early identification and treatment of OH is met by several pharmacological and non-pharmacological interventions, however, the majority have limited effect, and increase the risk of adverse drug effects due to polypharmacy. In recent years, epidural and transcutaneous spinal cord stimulation has been explored with promising results as a potential treatment to CV dysfunction in SCI. To date, only individuals with a chronic SCI (>1 year) were included in these studies.

The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 days after injury), during their inpatient rehabilitation. Optimal stimulation sites and parameters that increase and stabilize systolic BP (SBP) within the normotensive range (110-120 mmHg) during an orthostatic challenge will be sought. In this crossover randomized controlled trial (RCT), the effect of optimal CV stimulation and sham stimulation on BP and orthostatic symptoms will be assessed and compared.

The information gleaned from this work will allow design and implementation of scTS interventions in the early phase following an SCI, allowing full participation in inpatient rehabilitation programs, which are often hindered by the patients' autonomic dysfunction.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Blood Pressure
• Cardiovascular Diseases
• Central Nervous System Diseases
• Hypotension
• Hypotension, Orthostatic
• Nervous System Diseases
• Orthostatic Hypotension
• Spinal Cord Diseases
• Spinal Cord Injuries
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Diagnostic Test:
• Orthostatic challenge
Designed to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee. This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation.

Device:
• Biostim-5 transcutaneous spinal stimulation - Mapping
Transcutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz.
• Biostim-5 transcutaneous spinal stimulation - "Optimal" testing
Based on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg).
• Biostim-5 transcutaneous spinal stimulation - "Sham" testing
Based on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

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