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| Name | Class |
|---|---|
| PathMaker Neurosystems Inc. | INDUSTRY |
| Erchonia Corporation | INDUSTRY |
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The goal of this Spinal Cord Injury (SCI) Open-Label Clinical Trial is to test the safety and feasibility of the intervention. The study aims to answer whether implementing this intervention on inpatients at a specialized rehabilitation hospital is possible. All participants will receive the intervention and be asked to report side effects and tolerability. Additionally, injury markers for safety and signal recordings to detect changes will be assessed pre- and post-intervention.
This proposal seeks to apply non-invasive technology for hyperexcitability suppression, decrease inflammation, and promote restorative processes along the neural axis and the brain in patients with complete SCI in a highly innovative treatment paradigm with the potential for large-scale clinical impact.
This project will be the first to examine the proposed treatment approach in subacute inpatients with complete SCI. This will be a pilot open-label study using historical controls from the Spinal Cord Injury Model Data Center. A follow-up period (3- and 6-month post-intervention) will be required to evaluate the progression of these patients. The investigators aim to recruit eight patients based on historical admissions data from our institution.
Specific aims for this project are:
Aim 1: To assess safety and feasibility. Investigators will begin subject enrollment from the SCI inpatient unit at Spaulding Rehabilitation Hospital. The investigators will explore the effects of non-invasive neuromodulation + photobiomodulation among hospitalized American Spinal Cord Injury Association (ASIA) A/B patients (i.e., through analysis of enrollment, treatment tolerability, retention, medication use, and adverse effects).
Aim 2: To explore neurophysiological and clinical markers associated with recovery in SCI.
The investigators will evaluate inpatient evolution by measuring standard clinical assessments of sensorimotor function, the visual analog scale (VAS) for pain, the SCI pain interference scale, the modified Ashworth scale (MAS) for spasticity, and the Spinal Cord Injury - Quality of Life measurement system SCI-QOL. Neurophysiological markers will include surface electromyography (sEMG) to evaluate biological markers of corticospinal activity and sympathetic skin responses (SSR) to assess sudomotor function.
Aim 3: To explore mental health and cognitive function in this group of patients and assess this therapeutical approach's impact.
Hypothesis
Concerning Aim 1, The hypothesis is that the intervention and research procedures will be feasible and safe as evidenced by successful recruitment, screening, eligibility, enrollment rates, tolerability, low or mild adverse events, and no increased levels of specific enolase after the intervention.
The hypothesis for Aim 2 is that neurophysiological measurement will be feasible to collect and use as evidenced by tolerability to the procedures, quality, and reliability of the recorded signals, and viability and accuracy of the processing and analyses.
In the Aim 3 hypothesis, investigators can assess mental health and cognitive function successfully in this group of patients. The data from measures collected in this study will identify patterns across the time points, providing information for designing a future efficacy trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive dual electrical neuromodulation and photobiomodulation | Experimental | Trans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS) Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions AND Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tsDCS+pDCS | Device | Pathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Feasibility (functionality of the prototype device) | Device feasibility will be evaluated by device operability throughout the intervention period, these measurements will include; skin bioimpedance (Ohms), ramping up and down of electrical current in mA, and voltage stability during the stimulation (mA) period. Skin bioimpedance, ramping, and voltage stability will be combined to report device functionality represented as optimal stimulation or non-optimal. | Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Intervention safety through adverse events analysis as measured by the Common Terminology Criteria for Adverse Events (CTCAE) | Number of Participants presenting Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The American Spinal Cord Injury Association test (ASIA) | It's a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment. It involves a Motor and Sensory examination to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI), and whether the injury is Complete or Incomplete. ASIA is a standardized examination consisting of a myotonic-based motor examination, a dermatomal-based sensory examination, and an anorectal examination. Based on the findings of these examinations, injury severity or grade and level are assigned. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11805601 | Background | Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine (Phila Pa 1976). 2001 Dec 15;26(24 Suppl):S2-12. doi: 10.1097/00007632-200112151-00002. | |
| 16261122 | Background | Mirovsky Y, Shalmon E, Blankstein A, Halperin N. Complete paraplegia following gunshot injury without direct trauma to the cord. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2436-8. doi: 10.1097/01.brs.0000184588.54710.61. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| Low-level laser therapy | Device | Erchonia Corp. "Erchonia FX405" low level laser |
|
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| Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. They are generally completed by patients but are sometimes used to elicit opinions from health professionals. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Reflex recovery | Reflexes assessed by the treating physician during physical examination by exploring the extremities affected by the site of injury. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Spinal Cord Injury - Functional Index (SCI-FI) | SCI-FI is a system of patient-reported outcome measures of functional activities developed specifically with and for individuals with spinal cord injury (SCI). It consists of 9-item response theory-calibrated item banks that represent relevant and meaningful item content for individuals with SCI, span a wide range of functional abilities, and subdivide physical functioning into important subdomains, including essential mobility, self-care, and fine motor function. The SCI-FI measures five subdomains; the investigators will include three subdomains of physical function: virtual mobility, self-care, and ambulation in a conceptual structure unique to individuals with SCI. | Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks. |
| The modified Ashworth scale (MAS) | MAS is a six-category ordinal scale used to assess the resistance encountered during passive muscle stretching that does not require instrumentation and is quick to perform. The MAS is the current standard for clinical assessment of lower extremity spasticity and the most commonly used tool to evaluate the efficacy of pharmacologic and rehabilitation interventions for treating spasticity among patients with SCI. The MAS is the gold standard against which new assessment tools are evaluated. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| The Spinal Cord Injury - Quality of Life (SCI-QOL) | SCI-QOL is a measurement system that was developed to address the shortage of relevant and psychometrically sound patient-reported outcome (PRO) measures available for clinical care and research in (SCI) rehabilitation. It consists of 19 item banks, including the SCI-Functional Index banks, and three fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL) | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG) | The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG) is a brief, portable and easy-to-administer cognitive screening instrument developed at the Neuropsychiatry Unit of the Royal Melbourne Hospital, Australia, for use in psychiatric and neurologic patient populations, with an emphasis on balancing breadth and brevity, while ensuring sensitivity to the subtle changes seen across a range of disorders. It consists of 21 items that assess cognitive function across five cognitive functional domains: attention, memory, executive, visuo-constructional, and language, and is based on established cognitive tests, with items similar to those found in other cognitive screening tools. It has been designed to be administered in approximately 20 to 30 minutes. The NUCOG provides a total score of 100, with each of the five domains having a total score of 20. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| High-density surface electromyography (HD-sEMG) | High-density surface electromyography (HD-sEMG): is a non-invasive technique to measure electrical muscle activity with multiple (more than two) closely spaced electrodes overlying a restricted skin area. It is a method for recording Motor Unit Action Potentials (MUAP) over a muscle, using 2D arrays of closely spaced electrodes. Unlike traditional surface electromyography (sEMG), it accounts for both the signal's spatial and temporal characteristics, allowing a broader assessment of muscle electrophysiological activity. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Sympathetic skin responses (SSRs) | SSR is a convenient, non-invasive measure of autonomic function in various conditions, including SCI. It represents one of many techniques available to directly or indirectly measure sympathetic outflow to the skin. A measure of sympathetic cholinergic sudomotor function has been used to assess autonomic dysfunction in patients with spinal cord injury (SCI). It can be a useful surrogate measure of global autonomic function in research and as a diagnostic tool. | Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks. |
| Skin surveillance | The investigators will record skin pictures before and after each intervention to document safety, the investigators will only include the site where the electrodes are placed (wrist, neck, and abdomen), and the investigators won't have any identifiable features of the subject, like face, birthmarks, or tattoos. The investigators will get consent to perform this and provide a written agreement document to sign at the beginning of the study. | Baseline at day 0; during intervention (10 days) and post-intervention after 10 days |
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