- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998527
Non-Invasive Spinal Cord Stimulation After Injury
Non-Invasive Spinal Cord Stimulation and Respiratory Plasticity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Aim 1. This study is aimed to evaluate the effects of non-invasive transcutaneous electrical spinal-cord stimulation (TcESCS) applied below the neurological level of Spinal Cord Injury (SCI) on respiratory, upper extremity, and trunk functional and motor control properties and identify their underlying physiological mechanisms. Evaluation of the mechanisms of respiratory and motor control modulations evoked by the TcESCS will have important implications for the development of specific therapeutic strategies to fight complications of SCI. The objective of Aim 1 is to investigate whether TcESCS can significantly increase activation of motor networks. This work will be done by electrophysiological characterization of respiratory and other motor responses as assessed at rest and in response to the respiratory and other challenges in SCI individuals. Changes in functional measures will be assessed when the TcESCS device is turned "off" and "on". To evaluate "dose-dependent" effects, changes in surface electromyographic (sEMG) magnitude and muscle co-activation will be assessed when stimulation parameters and location are changed during respiratory efforts and motor tasks. The extent to which the stimulation is associated with the largest change in respiratory and sEMG parameters will be implemented as a strategy to be used during stimulation in combination with Respiratory Training (RT), Arm Training (AT), and Trunk Training (TT). To attain the objective of this aim, we will test the working hypothesis that TcESCS excites specific motor networks leading to amplified motor responses. We will test this hypothesis by applying TcESCS during our original approach of the Respiratory Motor Control Assessment (RMCA) and other sEMG-based assessments with kinematics to characterize respiratory, arm, and trunk motor function. During these assessments, beat-to-beat Blood Pressure/ Heart Rate (BP/HR), and respiratory rate will be recorded to evaluate respiratory-cardiovascular responses. The rationale for this aim is that successful completion of the proposed research will contribute fundamental elements to our basic knowledge, without which the therapeutic value of TcESCS cannot be understood. The acquisition of such knowledge is critical to the development of specific rehabilitative strategies. When the proposed studies for Aim 1 have been completed, we expect that motor and inter-related characteristics affected by TcESCS in patients with SCI will be established. Such findings would be important because it will allow us, for the first time, to evaluate the ability of non-invasive spinal cord stimulation to enhance the decreased state of spinal network activity thus demonstrating the potential for rehabilitation.
Study Aim 2. The goal is to evaluate the effectiveness and therapeutic mechanisms of the TcESCS combined with task-specific (Respiratory Training) and non-task-specific (Arm Training and Trunk Training) interventions for breathing. Identification of the physiological effects of potential rehabilitative approaches will have important implications for the development of specific therapeutic strategies. The objective of Aim 2 is to investigate the therapeutic effects of RT regimen in combination with TcESCS. This work will be done by using methods outlined in Aim 1 and additional clinical measures all assessed before training, and repeatedly during follow-up period. Working hypothesis that compare to RT alone and TcESCS alone, RT assisted by TcESCS leads to enhanced use-dependent plasticity of respiratory motor networks, leading the functional recovery will be tested by using the approach of detecting changes in respiratory and other motor control outcome measures in response to stimulation and training. The rationale for this aim is that successful completion of the proposed research will advance the field by providing new avenues for the application of activity-based therapy accompanied by the spinal cord stimulation. When the proposed studies for Aim 2 have been completed, it is expected that the rehabilitative capacity of RT with TcESCS will be determined. Such results are important, because, for the first time, identified therapeutic mechanisms of TcESCS will provide evidence that this intervention can enhance the effects of activity-based therapy in participants with SCI.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eddie Brown, MS, MBA
- Phone Number: 502-581-8675
- Email: edward.brown@louisville.edu
Study Contact Backup
- Name: Andrea Willhite, MS
- Phone Number: 502-581-8675
- Email: andrea.willhite@louisville.edu
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- Recruiting
- Frazier Rehabilitation and Neuroscience Institute
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Contact:
- Eddie Brown, MS, MBA
- Phone Number: 502-582-8675
- Email: edward.brown@louisville.edu
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Principal Investigator:
- Alexander V Ovechkin, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
All SCI research participants, irrespective of gender, will be selected based on the following:
Inclusion Criteria:
- At least 18 years of age at the time of enrollment;
- Stable medical condition;
- Non-progressive SCI T5 or above;
- Sustained SCI at least 12 months prior to enrollment;
- At least a 15% deficit in pulmonary function outcomes (FVC or FEV1) as was detected by screening spirometry
Exclusion Criteria:
- Untreated musculoskeletal dysfunction;
- Unhealed fracture;
- Untreated contracture or pressure sore;
- Ventilator dependence;
- Untreated depression, psychiatric disorder, or ongoing drug abuse;
- Major pulmonary or cardiovascular disease;
- Major esophageal or gastrointestinal disease;
- Endocrine disorder, malignancy, marked obesity, deep vein thrombosis, or HIV/AIDS related illness;
- Secondary causes of orthostatic hypotension (anemia, hypervolemia, endocrine, or neurological);
- Pregnancy by self-report.
All Non-Disabled research participants, irrespective of gender, will be selected based on the following:
Inclusion Criteria:
- At least 21 years of age at the time of enrollment.
- FVC and FEV1 values 80% of predicted or above indicating healthy pulmonary function by screening spirometry.
Exclusion Criteria:
- History of respiratory disease by self-report,
- History of cardiovascular disease by self-report.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-Disabled (ND) and Spinal Cord Injured (SCI) controls
The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention.
The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS.
The investigators will decide which stimulation type should be used for the post-mapping assessments.
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TcESCS is a non-invasive DC battery powered device.
Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels.
Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team.
Every research participant will be slowly acclimated to stimulation.
Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab.
During the stimulation training sessions, we will monitor blood pressure regularly throughout the session.
Other Names:
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Experimental: Spinal Cord Injured (SCI) intervention groups
The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT.
|
TcESCS is a non-invasive DC battery powered device.
Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels.
Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team.
Every research participant will be slowly acclimated to stimulation.
Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab.
During the stimulation training sessions, we will monitor blood pressure regularly throughout the session.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive respiratory electromyography
Time Frame: Through study completion, an average of 1 year.
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Respiratory muscle activity evaluated using vector analysis outcome measure.
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Through study completion, an average of 1 year.
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Spirometry
Time Frame: Through study completion, an average of 1 year.
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Respiratory activity evaluated using airflow outcome measure.
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Through study completion, an average of 1 year.
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Maximum airway pressure
Time Frame: Through study completion, an average of 1 year.
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Respiratory activity evaluated using airway pressure measurement.
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Through study completion, an average of 1 year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Neurophysiological Assessment (FNPA)
Time Frame: Through study completion, an average of 1 year.
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The FNPA assesses the motor capacity and control of the upper and lower extremities and trunk .
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Through study completion, an average of 1 year.
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Multisegmental Motor Response (MMR)
Time Frame: Through study completion, an average of 1 year.
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MMRs in response to non-invasive stimulation of the dorsal spinal cord assessed electromyographically
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Through study completion, an average of 1 year.
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Transcranial Magnetic Stimulation (TMS)
Time Frame: Through study completion, an average of 1 year.
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TMS of the cortex to assess the integrity of the descending corticospinal tracts
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Through study completion, an average of 1 year.
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Aerobic Endurance Test (VO2Peak)
Time Frame: Through study completion, an average of 1 year.
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Oxygen consumption during exercise
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Through study completion, an average of 1 year.
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Spinal Cord Independence Measure (SCIM)
Time Frame: Through study completion, an average of 1 year.
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Questionnaire to assess Self-Care and Mobility
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Through study completion, an average of 1 year.
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The Craig Handicap Assessment & Reporting Technique (CHART)
Time Frame: Through study completion, an average of 1 year.
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Questionnaire to measure the level of handicap in a community setting: physical independence, mobility, occupation, social integration, and economic self-sufficiency
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Through study completion, an average of 1 year.
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Beat-by-beat arterial blood pressure
Time Frame: During assessments.
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Non-invasive blood pressure monitoring
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During assessments.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Ovechkin, MD, PhD, University of Louisville
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.1279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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