Treatment for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
Parkinson Disease+1 More
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether a combination of physical therapy and medication may improve gait and balance in individuals with Parkinson's disease.

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Eligible Conditions

  • Parkinson Disease
  • Idiopathic Parkinson's Disease

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Parkinson Disease. Measurement will happen over the course of 12 weeks.

12 weeks
Balance Evaluation
Change in gait
Motor function

Trial Safety

Trial Design

3 Treatment Groups

Physical Therapy plus Atomoxetine

This trial requires 42 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Physical Therapy plus AtomoxetineAtomoxetine 10 mg daily in combination with PT or PT alone.
Physical Therapy plus MethylphenidateMethylphenidate 20 mg daily in combination with PT
Physical Therapy
Other
Physical Therapy (PT) will consist of two weekly sessions over a 12 week period using the Mellen center protocol PT for PD.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Patients with PD having significant balance or gait disorder with a score ≥2 in the Unified Parkinson Disease Rating Scale (UPDRS) 3.10 item 'independent walking but with substantial gait impairment; not related to off periods' occurring despite satisfactory motor control by dopaminergic therapy, with a medication regimen unlikely to change in the next 30 days.

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 parkinson disease be cured?

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A limited number of studies are available, but the information that is available is inconsistent, and indicates that this technique is ineffective. The use of the HHT may be the only treatment that can be effective and safe.

Unverified Answer

What causes parkinson disease?

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The number of risk factors for the development of PD is high, but they do not imply a specific cause of PD, and a single risk factor may not be enough to cause PD. We discuss whether the "motor hypothesis" of PD can explain our observations. To do this, we need to understand how and why different neurons are affected, so that strategies can be developed for preserving healthy neurons from acquiring mutations that can lead to PD.

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

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Based on population studies, an estimated 100,000 people under 65 get PD annually. Findings from a recent study, the prevalence of PD in our clinic is similar to the national prevalence of PD. Therefore, it seems prudent to look for PD patients at an enlarged institution such as Harbor-UCLA Medical Center.

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What are the signs of parkinson disease?

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The signs of PD are often insidious and do not occur suddenly. Dementia is a frequent feature of PD and may occur in the first 20 years of the disease. Some signs are more common at one time than another: tremor, rigidity, bradykinesia, gait- and posture-stabilizing problems occur later in the disease. Dementia may be the only sign of PD in older people or may be evident as the disease progresses.

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What are common treatments for parkinson disease?

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A wide variety of medications and non-pharmacological approaches have been used to treat parkinson disease over the last 40 years. Because evidence supporting the effectiveness of pharmacological interventions in non- Parkinson's disease cohorts is mixed, more rigorous, prospective validation of PD medication is urgently needed.

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What is parkinson disease?

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It is the degenerative disease of the substantia nigra that leads to the typical symptoms of rigidity, bradykinesia, tremor, and postural instability and gait disorders. We expect to be able to diagnose Parkinson's disease earlier due to the knowledge of its clinical manifestations as a result of clinical practice, which implies a good adherence of diagnostic criteria and a correct use of the therapeutic tools of non-pharmacological treatment such as physical therapy.

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What are the common side effects of treatment?

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Dopaminergic drugs cause side effects, which are common during the first year of treatment. There are several side effects that are more common than others. Most side effects fall into the digestive system and the central and peripheral nervous system, and they occur at a similar rate in all patients. It is important to understand when these side effects occur, and to monitor your symptoms. Side effects, which generally occur less frequently, are more common in elderly people and people with medical conditions such as kidney problems or [depressive disorders] that require long-term antidepressant medication.

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What does treatment usually treat?

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Patients with Parkinson's disease are often subjected to therapies which are intended to treat their symptoms, but patients may not receive full therapeutic benefit from treatments used routinely for the symptoms. It is difficult to reconcile this disconnection between patient and clinician perceptions of symptom efficacy and patient outcomes, including the need for further therapeutic intervention.

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Does treatment improve quality of life for those with parkinson disease?

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Results from a recent clinical trial found that treatment with rasagiline provided benefit in a number of aspects of Parkinson's disease-related health, mood, motor functioning, and quality of life and does not appear to have a adverse effect of worsening the condition. There is strong evidence that rasagiline has benefit in Parkinson's disease, and this has been confirmed in the UK through regulation by the Medicines and Healthcare Products Regulatory Agency.

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How serious can parkinson disease be?

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Despite the large number of years elapsed since disease onset, the majority of patients with PD (over 99%) meet U.S. movement disorder surveillance requirements. These are high risk, motor features that are disabling, and are not age related. These criteria are consistent with existing clinical diagnostic criteria for PD. There is a substantial diagnostic gap in the U.S. because of a general lack of awareness of motor features of PD. Therefore, a formal and consistent national surveillance program is needed to better delineate prodromal and PD symptoms and symptoms at a population level.

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Is treatment typically used in combination with any other treatments?

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The treatments commonly used in conjunction with deep brain stimulation do not change considerably over the course of treatment. There was no evidence of improvement during two years of follow-up but it is possible that a longer period of follow-up is required.

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Has treatment proven to be more effective than a placebo?

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Patients who were treated outperformed their non-treated counterparts on every outcome measure. Data from a recent study suggest that there are treatment-specific benefits in treating patients with parkinson disease compared with a placebo or treatment as-usual.

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