Motor Control Evaluation for Parkinson's Disease

Overseen By Hyosub Kim, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must be taking: Dopaminergic, Dopamine agonists

Disqualifiers: Musculoskeletal conditions, Seizure disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up.

Will I have to stop taking my current medications?

The trial requires participants with Parkinson's to be currently taking dopaminergic or dopamine agonist medications, so you will not need to stop these medications.

What data supports the effectiveness of the treatment Motor Control Assessment for Parkinson's Disease?

Research shows that using objective measurements to guide therapy decisions in Parkinson's disease can lead to significant improvements in motor and non-motor symptoms, suggesting that methods like Motor Control Assessment could be effective in evaluating and managing the condition. ^{1 2 3 4 5}

Is the Motor Control Evaluation for Parkinson's Disease treatment safe for humans?

The research articles reviewed focus on various treatments for Parkinson's disease, highlighting that adverse effects are usually mild or moderate, with only a small percentage of patients discontinuing treatment due to side effects. This suggests that treatments for motor control in Parkinson's disease generally have a safe side-effect profile. ^{6 7 8 9 10}

How does this treatment for Parkinson's disease differ from other treatments?

This treatment uses a digitizing tablet to objectively measure motor blocks (sudden stops in movement) in Parkinson's disease, which is a unique approach compared to traditional methods that rely on subjective clinical scales. It provides a low-cost, quick, and easy way to assess motor control issues specific to Parkinson's, potentially offering more precise monitoring of the condition. ^{11 12 13 14 15}

Research Team

Hyosub Kim, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for people aged 18-85 with Parkinson's Disease who can make reaching movements and are on Parkinson's medication. They must have a good level of mental function (MMSE score ≥ 26/30) and be able to attend all test sessions.

Inclusion Criteria

MMSE score ≥ 26/30

I can reach out about 8 inches.

I am between 18 and 85 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants perform reaching movements in a virtual reality setup with visual and force perturbations applied

4-6 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• Motor Control Assessment

Trial Overview The study focuses on understanding motor control in Parkinson's patients by observing their responses to changes while they reach for things in virtual reality.

Participant Groups

Group I: Behavioral testing Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The MLS motor performance test, which includes assessing 'tapping' regularity, provides a reliable method for evaluating motor dexterity in patients with Parkinson's disease, addressing issues of low interrater reliability found in traditional clinical scores.

This test allows for objective evaluation of therapeutic success by comparing motor performance results before and after treatment, making it a practical tool for therapy control in multicenter studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of symptoms of Parkinson's disease by apparative methods. Kraus, PH., Klotz, P., Fischer, A., et al.[2004]

The quantitative movement analysis (QMA) technique is a reliable and valid measure for assessing MS tremor and is sensitive to improvements following thalamic surgery, making it suitable for clinical trials.

Standard disability scales were found to be insensitive to functional improvements after surgery, while the box and blocks test effectively distinguished between patients with varying degrees of surgical success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical therapy for tremor in multiple sclerosis: an evaluation of outcome measures. Matsumoto, J., Morrow, D., Kaufman, K., et al.[2022]

In a study of 154 participants, those with Parkinson's disease who received treatment guided by objective measurements showed significant improvements in their overall disability scores compared to those who were treated based on conventional assessments.

The use of objective measurements led to better management of both motor and non-motor symptoms of Parkinson's disease, highlighting the importance of incorporating technology into treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A blinded, controlled trial of objective measurement in Parkinson's disease. Woodrow, H., Horne, MK., Fernando, CV., et al.[2020]

This study successfully identified objective methods to assess motor symptoms in Parkinson's disease (PD) patients, distinguishing between those treated with deep brain stimulation (DBS) and those treated with levodopa, using advanced sensor technology.

The classification accuracy of the methods was high, with 81% for training and 71% for test groups, indicating that these objective measures can effectively differentiate between healthy individuals and those with PD, enhancing the evaluation of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feature visualization and classification for the discrimination between individuals with Parkinson's disease under levodopa and DBS treatments. Machado, AR., Zaidan, HC., Paixão, AP., et al.[2018]

The Unified Parkinson's Disease Rating Scale is the most commonly used outcome measure in clinical trials for Parkinson's disease, but it has limitations such as poor inter-rater reliability and a lack of focus on nonmotor symptoms, prompting a revision to improve its effectiveness.

There is a significant need for better-defined measures of motor complications and quality of life in Parkinson's disease trials, as current methods lack consensus and validation, which could impact the assessment of neuroprotective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for clinical trials in Parkinson's disease: achievements and shortcomings. Marras, C., Lang, AE.[2019]

Motor fluctuations and dyskinesias are common and debilitating complications in Parkinson's disease patients within the first few years of treatment, significantly impacting their quality of life.

New therapeutic options, such as subcutaneous apomorphine and deep-brain stimulation, are available for patients who continue to experience motor complications despite optimal medical management, potentially improving both motor and nonmotor symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of motor complications in Parkinson disease: current and emerging therapies. Espay, AJ.[2013]

The oral combination of melevodopa/carbidopa has been shown to improve motor fluctuations in over 743 Parkinson's disease patients, with a faster absorption and more effective delivery compared to standard levodopa formulations.

Treatment with melevodopa/carbidopa does not increase the risk of adverse effects or levodopa-induced dyskinesias, suggesting it is a safe alternative for managing motor symptoms in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the clinical experience with melevodopa/carbidopa fixed combination in patients with Parkinson disease. Stocchi, F., Vacca, L.[2020]

The review identified eight rating scales for assessing drug-induced dyskinesia in Parkinson's disease, with the Abnormal Involuntary Movement Scale (AIMS) and the Rush Dyskinesia Rating Scale being the only ones currently recommended for use, albeit with weak support.

The newer scales, PDYS-26 and UDysRS, show excellent clinimetric properties and could become recommended tools if validated in broader clinical settings, highlighting the need for further testing before introducing new scales.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Colosimo, C., Martínez-Martín, P., Fabbrini, G., et al.[2022]

In a study of 450 Parkinson's disease patients, switching from standard levodopa to Sinemet CR led to significant improvements in motor function and daily living activities, especially in those with motor complications.

The treatment was generally well-tolerated, with only 10% of patients discontinuing due to side effects, and a majority of patients preferred Sinemet CR over their previous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with Parkinson's disease who transfer from standard levodopa to Sinemet CR: the STAR Study. The STAR Multicenter Study Group. Grandas, F., Martínez-Martín, P., Linazasoro, G.[2019]

Levodopa remains the most effective treatment for Parkinson's disease, but its long-term use can lead to motor fluctuations and dyskinesias, prompting clinicians to consider alternative therapies like MAO-B inhibitors and dopamine agonists as first-line treatments.

Despite advances in treatment options, there is currently no therapy available that can alter the progression of Parkinson's disease, highlighting the need for ongoing research into new drugs that are safe, effective, and capable of providing symptomatic relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in the pharmacological treatment of Parkinson's disease. Tuite, P., Riss, J.[2019]

The Advanced Sensing for Assessment of Parkinson's disease (ASAP) protocol provides a quantitative and reliable way to measure motor impairment in individuals with early to moderate Parkinson's disease, using grip force tracking under varying cognitive loads.

In a study of 30 participants, the ASAP protocol was able to predict scores on the Unified Parkinson Disease Rating Scale (UPDRS) with a mean prediction error of about 3.5 points, accounting for 76% of the variability, indicating its potential to track changes in motor symptoms over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of modified regression techniques to a quantitative assessment for the motor signs of Parkinson's disease. Brewer, BR., Pradhan, S., Carvell, G., et al.[2021]

Quantitative measures of motor performance, such as movement time and reaction time, can detect early signs of Parkinson's disease in patients with symptoms lasting less than 2 years, indicating their potential for early diagnosis.

Tests focusing on bradykinesia were found to be the most sensitive for detecting early Parkinson's disease, while rest tremor detection was the most specific, suggesting these tests could be useful for screening at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic analysis of early Parkinson's disease. Watts, RL., Mandir, AS., Ahn, KJ., et al.[2019]

Quantitative measures of motor performance, such as movement time and reaction time, can detect early signs of Parkinson's disease in patients with symptoms lasting less than 2 years, indicating their potential for early diagnosis.

Tests focusing on bradykinesia were found to be the most sensitive for detecting early Parkinson's disease, while rest tremor detection was the most specific, suggesting these tests could be useful for screening at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic analysis of early Parkinson's disease. Watts, RL., Mandir, AS., Ahn, KJ., et al.[2006]

A new measurement system using a digitizing tablet effectively evaluates motor block (MB) during hand movements in patients with Parkinson's disease, providing objective data on this condition.

The results from the digitizing tablet correlated well with traditional assessments of freezing in the Unified Parkinson's Disease Rating Scale, suggesting that this low-cost tool could enhance clinical evaluations of motor block in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to assess hand motor blocks in Parkinson's disease with digitizing tablet. Popovic, MB., Dzoljic, E., Kostic, V.[2019]

The ASAP protocol, which uses sensors to measure grip force under varying cognitive loads, provides a quantitative and reliable way to assess motor impairment in individuals with early to moderate Parkinson's disease, based on a study of 30 participants.

The protocol demonstrated a mean prediction error of about 3.5 points on the Unified Parkinson Disease Rating Scale (UPDRS), accounting for 76% of the variability in scores, suggesting it can effectively track changes in motor symptoms over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Modified Regression Techniques to a Quantitative Assessment for the Motor Signs of Parkinson's Disease. Brewer, ., Pradhan, S., Carvell, G., et al.[2021]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Assessment of symptoms of Parkinson's disease by apparative methods. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical therapy for tremor in multiple sclerosis: an evaluation of outcome measures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A blinded, controlled trial of objective measurement in Parkinson's disease. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Feature visualization and classification for the discrimination between individuals with Parkinson's disease under levodopa and DBS treatments. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Outcome measures for clinical trials in Parkinson's disease: achievements and shortcomings. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of motor complications in Parkinson disease: current and emerging therapies. [2013]

7. Italy pubmed.ncbi.nlm.nih.gov

A systematic review on the clinical experience with melevodopa/carbidopa fixed combination in patients with Parkinson disease. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Quality of life in patients with Parkinson's disease who transfer from standard levodopa to Sinemet CR: the STAR Study. The STAR Multicenter Study Group. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Recent developments in the pharmacological treatment of Parkinson's disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Application of modified regression techniques to a quantitative assessment for the motor signs of Parkinson's disease. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Electrophysiologic analysis of early Parkinson's disease. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Electrophysiologic analysis of early Parkinson's disease. [2006]

14. Japan pubmed.ncbi.nlm.nih.gov

A method to assess hand motor blocks in Parkinson's disease with digitizing tablet. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Application of Modified Regression Techniques to a Quantitative Assessment for the Motor Signs of Parkinson's Disease. [2021]