CLINICAL TRIAL

Epidural electrical stimulation (EES) of the cervical spinal cord for Nervous System Diseases

Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether electrical stimulation of the spinal cord can help improve arm and hand movement for individuals with stroke.

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About the trial for Nervous System Diseases

Eligible Conditions
Central Nervous System Diseases · Nervous System Diseases · Stroke · Brain Diseases · Cardiovascular Diseases

Treatment Groups

This trial involves 2 different treatments. Epidural Electrical Stimulation (EES) Of The Cervical Spinal Cord is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Epidural electrical stimulation (EES) of the cervical spinal cord
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Single, ischemic or hemorrhagic stroke more than 6 months prior to the time of enrollment with hemiparesis as a result.
Participants must be between the ages of 21 and 70 years old.
Scores higher than 7 and lower than 45 on the Fugl-Meyer scale
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Change from Baseline at Week 4
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from Baseline at Week 4
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from Baseline at Week 4.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Epidural electrical stimulation (EES) of the cervical spinal cord will improve 2 primary outcomes and 2 secondary outcomes in patients with Nervous System Diseases. Measurement will happen over the course of Change from Baseline at Week 1.

Evoked motor responses in arm muscles asses with surface electromyography (EMG)
CHANGE FROM BASELINE AT WEEK 1
We will measure bipolar surface EMGs from shoulder, arm and forearm muscles in responses to electrical stimulation of the cervical spinal cord. We will then quantify peak to peak amplitudes of evoked EMG potentials occurring within 50 ms from each stimulation pulse.
CHANGE FROM BASELINE AT WEEK 1
Selectivity of muscle recruitment
SCORE AT WEEK 1
We will measure bipolar surface EMGs from shoulder, arm and forearm muscles in responses to electrical stimulation of the cervical spinal cord. We will then quantify peak to peak amplitudes of evoked EMG potentials occurring within 50 ms from each stimulation pulse. Peak to peak amplitudes of muscle responses will be mathematically compared to responses in other muscles. Measurements will be performed for each electrode contact. A selectivity measure summarizing the ability to evoke responses in one muscle and not in other muscles will be assessed and reported for each muscle and each contact. Specificity scores range from 0 to 1 where 0 is no-specific and 1 is very specific.
SCORE AT WEEK 1
Shoulder, elbow and wrist joint angles
CHANGE FROM BASELINE AT WEEK 3
We will measure the maximal range of motion of each joint of the arm during a isotonic movements with and without electrical stimulation of the cervical spinal cord
CHANGE FROM BASELINE AT WEEK 3
Change in comfort/discomfort levels during electrical stimulation of the cervical spinal cord
CHANGE FROM BASELINE AT WEEK 4
After each stimulation trains patients will be asked to report their perceived discomfort level using a 10 value subjective scale. Low values will be assigned to low discomfort, and high values to high discomfort.
CHANGE FROM BASELINE AT WEEK 4

Patient Q & A Section

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

Can nervous system diseases be cured?

Curing nervous system diseases remains speculative. Only careful research is likely to clarify if all conditions can be cured or if a cure is only possible in certain cases. Although many people believe that they can cure nervous system conditions, in truth, even if treatment is successful and only temporary symptoms are temporarily alleviated, they will still have to accept that there is no cure.

Anonymous Patient Answer

What are the signs of nervous system diseases?

Nervous system diseases are divided into central nervous system diseases (CNS), peripheral nervous system diseases (PNS), skin and integumentary diseases and other miscellaneous illnesses. Signs of CNS diseases include blurred vision with or without double vision, slurred speech, headaches, altered mental status and, rarely, seizures. Of the PNS signs, the most common is neurogenic bowel, which may manifest itself as cramping abdominal pain, constipation or diarrhea. Skin and integumentary signs that are not neurological signs include anhidrosis, a cold or dry and itchy rash, itching or rash on parts of the body not usually exposed to the sun (e.g.

Anonymous Patient Answer

How many people get nervous system diseases a year in the United States?

This analysis suggests a substantial number of new cases of many neuropsychiatric disorders should occur annually in the U.S. The large, national sample can be used as a baseline when evaluating surveillance data in the U.S. for neurodevelopmental disorders.

Anonymous Patient Answer

What causes nervous system diseases?

The causes of nervous system diseases may include several factors that do not appear to be purely genetic. Damage to the brain or spinal cord due to traumatic head injury, systemic diseases such as malaria, or chronic drug misuse can precipitate neurological change.

Anonymous Patient Answer

What are common treatments for nervous system diseases?

For many nervous system diseases, there is no cure, so treatments focus on symptom management, such as pain management or medications, to help decrease side effects. In this article, common treatments for each nervous system disorder will be discussed.

Anonymous Patient Answer

What is nervous system diseases?

Nervous system diseases are mostly diagnosed by examining the nervous system and, at that, by using imaging and biochemistry, rather than by physical examination, unless they are medically emergency conditions such as stroke.\n

Anonymous Patient Answer

Have there been any new discoveries for treating nervous system diseases?

This is a review of current knowledge of neural health promotion and disease management based on clinical research evidence and literature review. This article discusses the recent advances in neurology and neurosurgery treatment, along with the role of the clinician on promoting a healthy lifestyle for all people, even those who have been diagnosed with these common psychiatric diseases and neurological conditions.

Anonymous Patient Answer

What are the latest developments in epidural electrical stimulation (ees) of the cervical spinal cord for therapeutic use?

EES is a novel noninvasive treatment method which has been used successfully to treat patients suffering from various neuropathic or inflammatory conditions, and has shown potential to be a useful and alternative therapeutic procedure for clinical use. It is also possible that future research could result in the development of innovative therapeutic protocols for future clinical use to treat a variety of central and peripheral neuropathic conditions for which the spinal cord offers an ideal neural pathway. However, further experimentation is warranted to assess the potential for use of EES as a method for spinal cord functional recovery as a result of multiple sclerosis.

Anonymous Patient Answer

Does nervous system diseases run in families?

Although more than 10% of people are thought to develop some disease attributable to mental illness or physical disability during their lifetimes, the vast majority of these people may have no first-hand, family experiences with such mental or physical problems. Although the familial transmission of a disease from one generation to the next is well known, the transmission through more than one generation has received scant attention. The possible contribution from this experience to present diagnoses needs to be examined.

Anonymous Patient Answer

Have there been other clinical trials involving epidural electrical stimulation (ees) of the cervical spinal cord?

Findings from a recent study of an investigation into the effects of ees on the sensory thresholds of the hindlimb of rats with chronic constriction injury indicate that ees may exert analgesic effects by enhancing the descending excitatory mechanisms of the spinoreticular system, but may not restore normal gait in rats with a surgically induced leg injury. If ees could be effective in relieving the pain associated with peripheral neuropathies of human origin, it may be feasible to demonstrate the benefits of ees for the treatment of these disorders.

Anonymous Patient Answer

How serious can nervous system diseases be?

There is no clear-cut cutoff number for the severity of a disease that will result in certain outcomes. However, there are definite features that indicate that certain people are more or less likely to develop a serious complication. For some of the diseases, a simple cutoff number in the disease course in time is not accurate to estimate the outcome. While not all neurological diseases can cause a similar clinical course, they are more likely to result in a permanent and permanent condition. Some neurological disorders are most likely to result in certain outcomes (e.g., dementia), or those with a more severe disease course. At least some neurological conditions are associated with a significant morbidity or even life expectancy.

Anonymous Patient Answer

What are the common side effects of epidural electrical stimulation (ees) of the cervical spinal cord?

Although the number of subjects was small, our findings indicate that EES may be associated with only mild side effects, but more studies with larger number of subjects are needed. It is possible that the duration of the electrical pulses may be too short for long-term application. Further research is necessary to investigate the efficacy and safety of long-term EES and other forms of repetitive electrical stimulation.

Anonymous Patient Answer
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