Active Remote Ischemic Conditioning for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
James J. Peters VA Medical Center, Bronx, NY
Amyotrophic Lateral Sclerosis+4 More
Active Remote Ischemic Conditioning - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a blood pressure cuff on a different limb may help improve motor function for individuals with spinal cord injury.

See full description

Eligible Conditions

  • Amyotrophic Lateral Sclerosis
  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Study Objectives

This trial is evaluating whether Active Remote Ischemic Conditioning will improve 1 primary outcome, 3 secondary outcomes, and 3 other outcomes in patients with Amyotrophic Lateral Sclerosis. Measurement will happen over the course of Change in peak-to-peak amplitude between immediately after completion of RIC plus isometric hand exercise and 15 mins after completion of RIC plus isometric hand exercise..

Change in averaged blood pressure between inflation and deflation phase during active/sham RIC.
Blood pressure
Change in averaged heart rate between inflation and deflation phase during active/sham RIC.
Heart rate
Change in averaged oxygen saturation between inflation and deflation phase during active/sham RIC.
Oxygen saturation
Change in mediator level between baseline measurement and immediately after completion of RIC.
Inflammatory mediators: the intensity of the gene expression of Toll-like receptor (TLR) signal pathway.
Change in peak-to-peak amplitude between baseline measurement and immediately after completion of RIC plus isometric hand exercise.
Changes of Electromyographic responses after RIC plus hand isometric exercise
Change in peak-to-peak amplitude between baseline measurement and immediately after completion of RIC.
Changes of Electromyographic responses after RIC but before hand isometric exercise
Change in peak-to-peak amplitude between immediately after completion of RIC plus isometric hand exercise and 15 mins after completion of RIC plus isometric hand exercise.
Changes of Electromyographic responses 15 mins after RIC plus hand isometric exercise

Trial Safety

Safety Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Trial Design

2 Treatment Groups

Active RIC + isometric hand exercise
1 of 2
Sham RIC + isometric hand exercise
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 21 total participants across 2 different treatment groups

This trial involves 2 different treatments. Active Remote Ischemic Conditioning 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.

Active RIC + isometric hand exerciseSubjects will receive an active remote ischemic conditioning (200mmHg cuff pressure) before an active isometric hand exercise.
Sham RIC + isometric hand exerciseSubjects will receive an sham remote ischemic conditioning (10 mmHg below the subjects' diastolic blood pressure) before an active isometric hand exercise.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in averaged oxygen saturation between inflation and deflation phase during active/sham ric.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in averaged oxygen saturation between inflation and deflation phase during active/sham ric. for reporting.

Who is running the study

Principal Investigator
N. Y. H.
Noam Y. Harel, Principal Investigator
Bronx VA Medical Center

Closest Location

James J. Peters VA Medical Center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able-bodied participants
Age between 18 and 75 years;
No known central or peripheral neurological disease or injury.
SCI participants
Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.
ALS participants
Age between 21 and 75 years;

Patient Q&A Section

Can spinal cord injuries be cured?

"SCI can be prevented by timely treatment with corticosteroids. Patients who have SCI may die by the time their SCI is treated, but patients who have a high risk of SCI may also die as a result of that risk. An alternative is to offer surgery so that the patient can receive the benefits of surgery while having a heightened chance of survival. SCI patients can die from other causes, but with appropriate treatment one has a high chance of being cured." - Anonymous Online Contributor

Unverified Answer

What are common treatments for spinal cord injuries?

"The type of spinal cord injury has a great influence on the type of treatment required, and may depend on how severe the injury is. The goals of treatment should depend on the severity of the injury and the quality of life a patient may have. Treatments can vary a great deal. Common treatments include inpatient care, home care, rehabilitation, and long-term therapy. In addition this paper presents the medical and surgical treatments that patients receive, their recovery rate, and the prognosis for each case." - Anonymous Online Contributor

Unverified Answer

How many people get spinal cord injuries a year in the United States?

"The latest estimates show that there are about 4,200 new SCI cases a year in the United States. However, many individuals with SCIs may never seek health care, and a much higher number of individuals may never be investigated for SCI." - Anonymous Online Contributor

Unverified Answer

What is spinal cord injuries?

"SCIs is a condition affecting the individual's health and well-being. Spinal cord injury is a major threat to patients that may lead to an inability to walk, move or talk, which can result in a complete loss of independence. It is necessary to have a general knowledge of these conditions, especially how to prevent them in the first place. It is also important to remember that these conditions can be corrected and even alleviated by the use of [treatments] such as a surgical implant, a spinal cord stimulator or a [neural implant]] to improve the quality of life." - Anonymous Online Contributor

Unverified Answer

What causes spinal cord injuries?

"More than 90% of spinal cord injuries reported in the United States are the result of falls from a great height. Of those injuries incurred with falls, 78% occurred in falls from a greater than 8-foot height. The risk of sustaining a spinal cord injury increases significantly as the height of the fall increases." - Anonymous Online Contributor

Unverified Answer

What are the signs of spinal cord injuries?

"Spinal cord injuries can be easily missed, making early diagnosis of patients with [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) difficult, and can lead to severe disability or even death. Nontraumatic causes of spinal cord injury are rare. All patients must be routinely examined for evidence of spondylotic change, decompression, and the assessment of the extent of injury. The use of a bedside radiograph can enhance the identification of spinal canal stenosis." - Anonymous Online Contributor

Unverified Answer

Is active remote ischemic conditioning typically used in combination with any other treatments?

"This review provides evidence for RIC use in three complementary or dual modality treatments, including multimodality, multiple system diseases, and nonperfusion situations. While it is difficult to infer treatment equivalency due to uncontrolled (unpowered) designs, RIC was shown to provide significant benefit in multiple patient-specific scenarios. Thus, RIC appears to be a promising strategy, providing a promising framework for multimodality applications in clinical practice." - Anonymous Online Contributor

Unverified Answer

How serious can spinal cord injuries be?

"The mortality rate due to a major spinal cord injury remains high, but progress may be made in the next 10 years, particularly in the development of new clinical treatments." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of active remote ischemic conditioning?

"In conclusion, common side effects of this IR-pAoP are the subjective and physical discomfort of IR-PC and the objective discomfort of IR-PC+SD. A small number of patients (3/32, 10%) reported that the IR-PC+SD method was painful for them. IR-PC and IR-PC+SD showed no significant difference in the frequency of serious complications." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving active remote ischemic conditioning?

"None of the clinical trials that have been done has involved this intervention, though there are a few basic principles of how ischemic conditioning will help. Remote ischemic conditioning may help the body regain its ability to ischemia by decreasing the overall amount of ischemia. Ischemic preconditioning, however, has the advantage of taking place on an individual basis before an ischemic event. Remote ischemic conditioning has yet to be studied in any clinical trials." - Anonymous Online Contributor

Unverified Answer

What is active remote ischemic conditioning?

"Results from a recent paper of this pilot study show that the active form of RIPC produces no significant improvements in walking ability or functional status in individuals with chronic spinal cord injury when compared to passive RIPC or placebo." - Anonymous Online Contributor

Unverified Answer

Has active remote ischemic conditioning proven to be more effective than a placebo?

"Patients who received the protocol therapy had a significant decrease in SCI-related pain scores that was comparable to those in the control group. Moreover, the therapy did not have any detrimental effects on neurologic recovery. Thus ATRC is considered a safe active procedure that might be considered for future clinical trials to assess efficacy of remote ischemic conditioning as a novel therapeutic strategy for acute pain treatment post SCI." - 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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