Treatment for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Parkinson Disease
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether exercise rehabilitation can improve cognition and slow wave sleep in individuals with Parkinson's disease.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Parkinson Disease. Measurement will happen over the course of Baseline to twelve weeks.

Baseline to twelve weeks
Change in Cognition in Stroop inhibition
Week 24
Change in slow wave sleep (SWS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Exercise Group
Placebo group

This trial requires 120 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.

Exercise GroupPD participants randomized to progressive resistance training PRT) will have 12 weeks of supervised PRT 3 times per week. After the 1st 12 weeks, responders to PRT (increase in slow wave sleep) will continue PRT for an additional 12 weeks, non-responders to PRT will transition to endurance training (ET).
Delayed Exercise GroupPD participants randomized to the delayed exercise control group will not exercise for the 1st 12 weeks of the study. After the 1st 12 weeks, participants in the delayed exercise group will transition to PRT for the 2nd 12 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to twelve week and change from twelve weeks to 24 weeks.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to twelve week and change from twelve weeks to 24 weeks. for reporting.

Who is running the study

Principal Investigator
A. A.
Prof. Amy Amara, Associate Professor
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

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:
Hoehn and Yahr stage 2-3 (performed at screening visit)
age ≥ 45
on stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and <26 (performed at screening visit)
clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as at least one of the following: rest tremor, rigidity, and/or postural instability (per United Kingdom PD Brain Bank Criteria)
No contraindications to an exercise program.
fails exercise readiness evaluation at screening visit
regular participation in an exercise program
cardiovascular or pulmonary disease, including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within the past year, or chronic obstructive pulmonary disease (COPD)
shift workers

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 is parkinson disease?

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The onset of movement disorders usually occurs in a group of syndromes that have high diagnostic overlap with Parkinson disease. The prevalence of Lewy-related disease in non-parkinsonian movement disorder patients is high compared to the general population.

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What are the signs of parkinson disease?

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Several signs of [parkinson disease](https://www.withpower.com/clinical-trials/parkinson-disease) include tremor, briskness of limb movement, and loss of coordination. Moreover, these signs may be intermittent and can occur at any moment during the day or night, irrespective of external stimulation. This contrasts with symptoms of a restless legs syndrome, which typically first arise in the middle of the day, peak throughout the day or night, and often go away with only short-term reduction of dopamine, such as from taking a dopamine agonist. All of these manifestations of parkinsonian symptoms can be disabling in their own right and constitute a serious neurologic problem. Clinically, a doctor should first consider the possibility of a diagnosis other than Parkinson's disease when examining one's patient with parkinsonism-like symptoms.

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How many people get parkinson disease a year in the United States?

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Although PD is a rare disease in the United States, [10,000 PD patients were diagnosed per year] in 1995, this number is likely to be an overenhancement. Most of these patients are less than 80 years of age or less likely to be a resident of the United States. Further, PD-specific hospital admissions are decreasing.

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Can parkinson disease be cured?

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This report demonstrates that the ability of certain Parkinson's disease treatments to control motor symptoms may be improved by concomitant use of selegiline and deep brain stimulation in patients with severe parkinsonism. Data from a recent study and their clinical implications underscore the potential benefit and importance of deep brain stimulation in treating motor symptoms associated with Parkinson's disease.

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What causes parkinson disease?

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The exact cause of Parkinson's disease is unknown, although it is known to be associated with certain genetic risk factors and a combination of environmental and environmental factors. No single environmental factor seems to be responsible for the development of Parkinson's disease.

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What are common treatments for parkinson disease?

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Treatment for Parkinson disease includes surgery, thalamotomy, and deep brain stimulation (DBS). Pharmacological treatment options include monoaminergics, dopamine agonists, and levodopa. DBS has become an important treatment for advanced disease, including freezing of gait. This article also explores common treatments other than DBS for Parkinson's disease.

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Have there been any new discoveries for treating parkinson disease?

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Currently, levodopa, selegiline and other dopa-decarboxylase inhibitors remain the main forms of treatment for PD. Levodopa and selegiline are effective with regard to reducing symptoms in the early stages of the disease, but patients are frequently affected by the worsening of their levodopa-induced dyskinesia, a condition that is often irreversible and is often treated with some sort of deep brain stimulation stimulation to alleviate its damaging side effects. Also, many patients are given a 'drug holiday' for a month to two weeks when they experience an improvement in motor symptoms, as an attempt to reduce the use of levodopa.

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How serious can parkinson disease be?

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Serious complications may include pneumonia, deep-vein thrombosis, and sudden cardiac death. Patients can develop new signs and symptoms of Parkinson disease, including rapid onset hypokaliemia and high serum magnesium.

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Does parkinson disease run in families?

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We found little familial aggregation in Parkinson's disease but a significant association between Parkinson's disease and a family history of Parkinson's disease. The exact genetic makeup of such familial aggregation remains uncertain. In the future, it may help to pinpoint a specific gene influencing the disease.

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What is treatment?

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There is a tendency for PD patients to assume that they should not be treated, but the [right treatment at the right time] for PD patients depends on factors such as severity of motor impairment and level of disability. Current pharmacological therapy for PD is not entirely satisfactory. New treatment strategies need to be established in the future.

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Who should consider clinical trials for parkinson disease?

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Clinic staffs need to consider the inclusion and exclusion criteria of clinical trial and other related information. If the patients show a stable course and can tolerate the adverse events of clinical trials, their participation in clinical trials would be acceptable.

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Has treatment proven to be more effective than a placebo?

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The placebo effect may be an important factor for the clinical treatment of PD, considering the high number of responders. It remains unclear which factors predisposing PD patients to show a placebo effect.

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