Treatment for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spaulding Rehabilitation Hospital, Cambridge, MA
Spinal Cord Injuries+1 More
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether breathing low oxygen levels and electrical stimulation may help restore hand function in individuals with incomplete spinal cord injury.

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Eligible Conditions

  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 2 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline, once each intervention week (days 5, 10, and 15), and once at followup (week 8).

Week 8
Change in upper extremity function
Change in upper extremity strength
Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity function
Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity strength

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (...
1 of 2
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation...
1 of 2
Active Control
Non-Treatment Group

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS)Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS)Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, once each intervention week (days 5, 10, and 15), and once at followup (week 8)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, once each intervention week (days 5, 10, and 15), and once at followup (week 8) for reporting.

Who is running the study

Principal Investigator
R. T.
Prof. Randy Trumbower,, PhD
Spaulding Rehabilitation Hospital

Closest Location

Spaulding Rehabilitation Hospital - Cambridge, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 to 65 years old
medically stable with medical clearance from physician to participate
SCI at or below C3 and at or above C7
non-progressive etiology of spinal injury
American Spinal Injury Association Impairment Scale (AIS) C-D at initial screen
at least 1 year post-injury (chronic)
difficulty independently performing hand functions in activities of daily living

Patient Q&A Section

What are common treatments for anoxia?

"The use of CO and supplemental oxygen is associated with more adverse events in patients with anoxia. Patients usually begin oxygen treatment after the treatment of anoxia ceases." - Anonymous Online Contributor

Unverified Answer

What are the signs of anoxia?

"This research shows that the severity of anoxia in the postnatal period is influenced by maternal stressors, such as depression, low body mass index, and alcohol or cannabis use. Anoxia occurred because of inadequate delivery of oxygen from uterine contractions to the fetus." - Anonymous Online Contributor

Unverified Answer

Can anoxia be cured?

"This is the first demonstration of the long-term effects of a subcutaneous anoxic challenge on postural control of human subjects subjected to a static postural challenge with a simulated one-armed support beam. In a recent study, findings underscore the importance of maintaining good hydration after subcutaneous exposure to anoxic stress, as anoxia alone is not sufficient to induce fatigue." - Anonymous Online Contributor

Unverified Answer

What is anoxia?

"Anoxia is a shortage of O and affects organisms in a variety of ways. Most research has focused on how organisms such as bacteria and plants can deal with anoxia, and this article discusses the effects of this scarcity on organisms that cannot deal as well. This article discusses the ways in which anoxia can affect organisms that are either autotrophic (autotrophs are organisms that make organic molecules using energy obtained from the use of light and organic material) or heterotrophic (Heterotrophs make their own life-supporting molecules or from organic material). Some organisms have both mechanisms for dealing with anoxia.\n\n- http://tamu." - Anonymous Online Contributor

Unverified Answer

How many people get anoxia a year in the United States?

"There are 466,918 anoxia cases annually in the United States, mainly attributable to diving. The risk of death of these anoxia cases in the US might be reduced by 20% to 30% if the current guidelines on anoxia-related diving, such as decompression stops at 2 to 3 minutes, were adhered to thoroughly." - Anonymous Online Contributor

Unverified Answer

What causes anoxia?

"Anoxia causes brain cells to swell up and die; these cells are removed, or the brain is damaged, which causes many neurological diseases. People do not notice these diseases if they are not properly cared for, or if they don't have proper diagnostic tests, or if they don't bother follow-up visits. If they are suspected of dying, they should be seen within 72 hours to confirm brain death and obtain a proper neurological examination. If anoxia is a known contributor to brain damage, then it's important to get the person to the hospital as soon as possible because the best treatment is not available in their community." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Antibody therapy that has been shown to work in animal models is not effective in patients with ALS in two of the largest ALS studies to date. Current studies have not yet identified if other antigens, or combinations of antigens, are effective. It remains unclear if some of the antibodies work better than others and why the results are not consistent. There is also not sufficient evidence to conclude that any drug or drug combination works better than placebo in ALS. There is also insufficient evidence to determine which treatments are better in ALS than others for people whose symptoms appear similar. Current evidence suggests that exercise improves survival for people with ALS." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"There is no current approved treatment for retinopathy and no consensus regarding the best treatment for retinopathy of prematurity in these newborns. Treatment varies from simple observation to surgical intervention." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anoxia?

"For over 30 years, Anoxia researchers have studied hypoxic conditions and cell physiology. With the advent of the new technologies for gene and protein expression, researchers could study the mechanism underlying Anoxia-induced hypoxia more closely and better. They will elucidate the molecular mechanisms of this hypoxic condition and also develop new and better therapeutic approaches. For Anoxia, this study will provide the next generation of Anoxia researchers with a platform to investigate potential therapeutic approaches against Anoxia or its complications." - Anonymous Online Contributor

Unverified Answer

How serious can anoxia be?

"Although anoxia may not cause any specific clinical symptoms, patients suffering from anoxic coma seem to be more severely affected, regardless of the degree of anoxia. Anoxic seizures and a coma are probably among the results of the severity of anoxia." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"In most of the patients' cases, treatment was administered for non-articular OA and not for cartilage defects. The patients should be assessed to see on which kind of treatment would probably work even though this is not the standard treatment. In the cases where treatment was effective, radiographic changes were seen to be stable, despite the lack of treatment." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"There are few treatments with strong treatment evidence. The most frequent combination treatment is steroids followed by antibiotics and mechanical ventilation; treatment combination with steroids appeared more frequently in patients with a greater proportion of neurological deficit at initiation of treatment. More prospective randomized studies are needed to draw definite conclusions regarding the most effective combination treatment and to verify treatment effects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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