CLINICAL TRIAL

Treatment for Paresis

Recruiting · 18+ · All Sexes · Martinez, CA

This study is evaluating whether a method of brain stimulation may help improve walking ability for individuals who have had a stroke.

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About the trial for Paresis

Eligible Conditions
Stroke · Gait Dysfunction · Paresis · Hemiparesis

Treatment Groups

This trial involves a single treatment. Treatment 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.
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 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A stroke is confirmed by neuroimaging if it is visible on a CT or MRI scan. show original
A stroke which occurred 3 months prior to enrolling in the study was excluded from the analysis. show original
The ability to walk, independently and at least 25' on level ground, even if requiring a brace or assistive device (like a cane), is a requirement for this job. show original
over ALL other factors Veteran Status will always be a factor that is prioritized over all others show original
hemiparesis resulting from stroke
One-sided, stroke that affects the cortex or a sub-cortical area. show original
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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: immediately post-PAS
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately post-PAS
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: immediately post-PAS.
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 Treatment will improve 2 primary outcomes in patients with Paresis. Measurement will happen over the course of immediately post-PAS.

change in Motor Evoked Potential (MEP) size
IMMEDIATELY POST-PAS
The difference in MEP size (area) post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 1. MEP size is considered an indicator of cortical/neural excitability. An increase in MEP size would suggest that PAS enhanced cortical excitability. MEP size can be expressed in either absolute/raw values or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
IMMEDIATELY POST-PAS
change in ankle plantarflexor power (A2)
IMMEDIATELY POST-PAS
The difference in A2 post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 2. A2 quantifies the dynamic force producing capacity and is critical to forward progression during walking. An increase in A2 amplitude, area, or slope would suggest that PAS enhanced cortical excitability/neural connectivity enabling production of greater, more effective plantarflexor power during walking. A2 is expressed relative to the individual subject's body weight. Change in A2 can be expressed in either these normalized units or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
IMMEDIATELY POST-PAS

Patient Q & A Section

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

What are the latest developments in treatment for therapeutic use?

Therapies include a host of treatments, some which are being translated into the real world. The field is evolving and still faces the challenge of the very high percentage of dropouts. These developments make for challenging clinical and organizational challenges.

Anonymous Patient Answer

What are common treatments for paresis?

It is often impractical for a patient with spastic paresis to use an orthosis or splint, due to a lack of understanding of the mechanism for which the spasticity is in part caused. There are four common treatments for paresis: manual training and spastic physiotherapy, anti-spastic surgery, muscle relaxation, anti-sphincteric drugs, or splints, braces, or orthotics. The common treatments often offer relief from some spastic paresis to some degree, but their use is not recommended if there is any serious pain and stiffness.

Anonymous Patient Answer

Can paresis be cured?

Paresis is frequently cured without specific surgical planning. The decision as to whether an operation should be performed must be based on the specific type of paraplegia and the history of the patient. In certain cases, the use of a baclofen pump can be an effective and convenient therapy.

Anonymous Patient Answer

What is paresis?

Paresis is a neurological syndrome characterized by motor (movement), sensory (sense), and autonomic disturbances; these may be localised or extrapyramidal in nature. Paresis can be caused by a variety of underlying conditions. The differential diagnosis includes spinocerebellar ataxia type 2, hereditary motor and sensory neuropathies, Friedreich's ataxia, myasthenia gravis, and systemic lupus erythematosus (SLE), amongst others. \n\nThis article contains text from the http://www.purescience.com/text_1.

Anonymous Patient Answer

What are the signs of paresis?

Persistent and unexplained muscle weakness can signify a diagnosis of myasthenia gravis. All patients with paresis should have their antibody titre investigated if no explanation for the weakness can be found.

Anonymous Patient Answer

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

Paralysis remains a serious problem in the United States. The occurrence of paresis from a nontraumatic etiology differs widely among countries and among races. Paralysis rates of patients who have received an acute hospital admission for a nonthrombolytic stroke are similar in the United Kingdom and the United States.

Anonymous Patient Answer

What causes paresis?

While the most common cause of paralysis is encephalopathy (particularly in ICUs), autoimmune processes can also cause paresis and are often undiagnosed. These autoimmune disorders can be treated with steroids.

Anonymous Patient Answer

What does treatment usually treat?

More than 50% of patients receiving palliative treatment believe that medications treat the symptoms rather than the disease. Physicians and pharmaceutical companies need to educate patients about treatment for symptoms and to avoid the "treatment-for-symptom" phenomenon by providing appropriate patient lists for these treatments.

Anonymous Patient Answer

How does treatment work?

Results from a recent paper demonstrate that postoperative motor function at 5-year follow-up was similar to that following conservative treatment, but motor and neurological recovery is more limited in adults compared to children.

Anonymous Patient Answer

Does treatment improve quality of life for those with paresis?

Patients and their caregivers reported an acceptable improvement in quality of life in PLS patients who were treated with baclofen infusion pump therapy. These improvements were associated with reductions in pain, improved movement control, and increased ability to perform leisure activities, as well as an improvement in caregiver's quality of life.

Anonymous Patient Answer

Who should consider clinical trials for paresis?

When patients with stroke-related muscle paresis were asked about outcomes they would consider, they frequently cite [pain, functional capacity, and quality of life as the most important outcomes for future clinical trials]. Physicians should take the patients' expectations into account when they trial new therapies for a variety of conditions. Physicians who do clinical trials for paresis should consider clinical trials for both aphasia and dysphagia. Clinical trials for paresis are currently underutilized.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Treatment with antidepressants, psychotropic medications, analgesics for neuropathic pain, hypnosis, and physical therapy has shown effectiveness for treating some symptoms of neuropathic pain. A placebo is less effective than no therapy in treating neuropathic pain because physical therapy, hypnosis, and psychotropic medications can effectively alleviate symptoms for a time, and have therefore been called temporary 'placebos'. None of the studies in this review were adequately powered to determine if treatment with a placebo, or placebo alone, was more effective at reducing symptom severity compared to no treatment. Further research is required to determine more specifically which intervention (placebo or no-treatment) has the strongest effect on patients' symptoms of neuropathic pain.

Anonymous Patient Answer
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