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

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthostatic challenge
Biostim-5 transcutaneous spinal stimulation - Mapping
Biostim-5 transcutaneous spinal stimulation - "Optimal" testing
Biostim-5 transcutaneous spinal stimulation - "Sham" testing
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Transcutaneous Spinal Cord Stimulation, Spinal stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation, Acute spinal cord injury, Hypotension, Acute inpatient rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Baseline hypotension - resting supine or seated SBP < 90mmHg; SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; 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

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Optimal stimulation (for a blood pressure response)

Sham stimulation

Arm Description

Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.

Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.

Outcomes

Primary Outcome Measures

Optimal stimulation sites
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
Optimal stimulation frequency
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
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.
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.

Secondary Outcome Measures

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
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
Feasibility of applying scTS in inpatient settings - compliance
The ratio of total number of completed sessions divided by the number of sessions initially planned.
Feasibility of applying scTS in inpatient settings - session duration
The length of time of each session and total length will be recorded.
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.
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
Additional hemodynamic measure - diastolic blood pressure
These measures will be collected on a daily basis throughout the trial
Additional hemodynamic measure - heart rate
These measures will be collected on a daily basis throughout the trial

Full Information

First Posted
January 25, 2023
Last Updated
May 8, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05731986
Brief Title
Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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: 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. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension, Orthostatic Hypotension, Cardiovascular Diseases, Acute Spinal Cord Injury, Blood Pressure
Keywords
Transcutaneous Spinal Cord Stimulation, Spinal stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation, Acute spinal cord injury, Hypotension, Acute inpatient rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Twelve individuals admitted to inpatient rehabilitation after sustaining a spinal cord injury will be enrolled. They will complete baseline assessments including an orthostatic sit-up test and neurophysiological mapping. Subsequently, the intervention will consist of two days of stimulation mapping to locate the optimal spinal segment for a blood pressure response. Participants will then be randomly assigned to two groups that would determine the order of the two testing days (optimal/sham), where stimulation is applied during an orthostatic test.
Masking
Participant
Masking Description
During the two testing days, participants will be blinded to the order of the stimulation. One testing day will include an orthostatic sit-up test with optimal stimulation (for a blood pressure response), while the other will include a sit-up test with sham stimulation
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optimal stimulation (for a blood pressure response)
Arm Type
Active Comparator
Arm Description
Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.
Intervention Type
Diagnostic Test
Intervention Name(s)
Orthostatic challenge
Other Intervention Name(s)
Sit-up test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Biostim-5 transcutaneous spinal stimulation - Mapping
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Biostim-5 transcutaneous spinal stimulation - "Optimal" testing
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Biostim-5 transcutaneous spinal stimulation - "Sham" testing
Intervention Description
Based on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.
Primary Outcome Measure Information:
Title
Optimal stimulation sites
Description
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
Time Frame
Through Mapping and testing sessions, average of 2 weeks
Title
Optimal stimulation frequency
Description
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
Time Frame
Through Mapping and testing sessions, average of 2 weeks
Title
Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP
Description
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.
Time Frame
Throughout the experiment, average of 2 weeks
Title
Change in Orthostatic symptoms when stimulation is applied
Description
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.
Time Frame
Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) for pain
Description
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
Time Frame
Throughout the experiment, average of 2 weeks
Title
Skin integrity assessment
Description
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
Time Frame
Throughout the experiment, average of 2 weeks
Title
Feasibility of applying scTS in inpatient settings - compliance
Description
The ratio of total number of completed sessions divided by the number of sessions initially planned.
Time Frame
Throughout the experiment, average of 2 weeks
Title
Feasibility of applying scTS in inpatient settings - session duration
Description
The length of time of each session and total length will be recorded.
Time Frame
Throughout the experiment, average of 2 weeks
Title
Feasibility of applying scTS in inpatient settings - effect on therapy
Description
Total therapy time during inpatient rehabilitation will be recorded to ensure there is no interruption to the normal therapy schedule.
Time Frame
Throughout the experiment, average of 2 weeks
Title
Electromyography (EMG) of leg muscles - muscle activation (analysis of mean and peak amplitudes)
Description
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
Time Frame
Through Mapping and testing sessions, average of 2 weeks
Title
Additional hemodynamic measure - diastolic blood pressure
Description
These measures will be collected on a daily basis throughout the trial
Time Frame
throughout the trial, average of 2 weeks
Title
Additional hemodynamic measure - heart rate
Description
These measures will be collected on a daily basis throughout the trial
Time Frame
throughout the trial, average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Baseline hypotension - resting supine or seated SBP < 90mmHg; SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LeighAnn Martinez, BA
Phone
(973)324-3557
Email
lmartinez@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Einat Engel-Haber, MD
Email
ehaber@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail F Forrest, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LeighAnn Martinez, BA
Phone
973-324-3557
Email
lmartinez@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Einat Engel-Haber, MD
Email
ehaber@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Gail F Forrest, PhD
First Name & Middle Initial & Last Name & Degree
Steven Kirshblum, MD
First Name & Middle Initial & Last Name & Degree
Einat Engel-Haber, MD
First Name & Middle Initial & Last Name & Degree
Brittany Snider, DO

12. IPD Sharing Statement

Plan to Share IPD
No

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

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