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Electromyography Signals as Biomarkers for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168504
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Norconnect Inc

Tracking Information
First Submitted Date June 18, 2014
First Posted Date June 20, 2014
Last Update Posted Date October 8, 2015
Study Start Date June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2014)
Number of successfully identified participants [ Time Frame: one year ]
The successful outcome will be measured as 15 successful identifications of patients with Parkinson's disease (PD) out of 20 subjects of 10 PD patients and 10 healthy controls
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electromyography Signals as Biomarkers for Parkinson's Disease
Official Title Electromyography Signals as Biomarkers for Parkinson's Disease
Brief Summary A simple, painless and reliable method to detect Parkinson's disease at an early stage is very important to patients, doctors and researchers. Doctors want to help patients early, and scientists want to select patients for their research who will help in development of better drugs. We hope that the changes in electrical activity of hand muscles during handwriting will help in early detection of this disease.
Detailed Description

This study will use the analysis of electrical activity recorded from hand muscles during handwriting and at rest. There will be two groups of subjects: early Parkinson's disease patients and healthy people. The researcher analyzing the recorded data will not know who is a patient and who is healthy, as subjects will be identified only by numbers. Healthy volunteers will be of similar age as patients. In the course of this study, various properties of hand muscle electrical activity will be examined, and results will be verified by third party.

A neurologist will accrue 10 early PD patients with mild symptoms and 10 healthy controls. Inclusion and exclusion criteria of participants (early PD patients and healthy controls) will be described by the clients after a discussion with the neurologist. It is important that the healthy controls should be similar to the early PD patients in terms of age, gender, and other factors which might also cause differences in EMG signals. The neurologist's diagnosis of the participants' disease status (early PD or health) will be considered the "reference standard test" results, and will be kept confidential until the end of the study. That is, only the neurologist knows the diagnosis for each participant accrued at the end of the study.

An assistant (recorder), who does not know the disease status of these participants and does not know the study design (e.g., how many PD participants and how many health controls), will record EMG signals of these participants following the pre-specified protocol. The order of these participants being examined by the recorder will be randomized. The signals will be analyzed by the software provided by the clients and results needed for diagnosis will be outputted and saved in individual files, one for each participant.

Another assistant (reader), who has no contact with these participants and does not know the study design (e.g., how many PD participants and how many health controls), would then diagnose each individual as early PD or health based on the analysis outputs, according to pre-specified rules as described in the proposal.

At the end of the study, the reader's diagnoses will be compared to the neurologist's diagnosis by a third party. A diagnosis by the reader is defined as correct if this diagnosis is the same as the neurologist's diagnosis. The success rate of our approach of diagnosing early PD disease is defined by the total number of corrected diagnoses by the reader divided by the total number of diagnoses, which equals to the total number of participants.

Statistical analysis The null hypothesis will be rejected, i.e., the client's claim about the capability of their approach in diagnosing early PD should be accepted, if the number of correct diagnosis equals to or exceeds 15, Otherwise, the null hypothesis will not be rejected and the clients' claim about the capability of their approach in diagnosing early PD will not be accepted. We claim that the success rate of their approach should be no less than 0.8.

We denote P0 (= 0.5) as the success rate under the null hypothesis, and P1 as the success rate under the alternative hypothesis. We expect P1 >= 0.80 based on pilot study results. A sample size of 20 participants achieves 80% power to detect a difference (P1-P0) of 0.30 using a one-sided binomial test. The target significance level is 0.05. The actual significance level achieved by this test is 0.0207. These results assume that the population proportion under the null hypothesis is 0.50.

As a secondary objective, the clients could also generate estimates and 95% confidence intervals of sensitivity and specificity of this approach for diagnosing PD.

However, it should be noted that given the small sample size, we couldn't produce accurate estimate of sensitivity and specificity. For example, with 10 PD participants, and assume that the sensitivity is about 0.9, the width of the 95% CI for the estimated sensitivity would be as large as 0.44.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

PD patients will be selected from the primary care clinic in Claxton - Hepburn Medical Center, Ogdensburg NY. The healthy participants will be selected from the population of St. Lawrence County, NY.

Selection of PD patients: PD confirmed, but with mild symptoms Selection of healthy controls: match in age/gender/education level/profession/etc. if possible.

Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • Healthy controls
    Healthy male and female subjects older than 18 years of age without the symptoms of Parkinson's disease. The ages of subjects in this group will be matching to the ages of subjects in Parkinson's disease group
  • Parkinson's disease patients
    male and female subjects older than 18 years of age at the early stage the disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2014)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Early PD (diagnosed within 6 months)
  • Older than 18 years old

Exclusion Criteria:

  • Less than 18 years old
  • Not taking anti depressants
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02168504
Other Study ID Numbers ESBPD_170614
100/2310 ( Other Identifier: Michael J. Fox Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norconnect Inc
Study Sponsor Norconnect Inc
Collaborators Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Michael Linderman, M. Sc. Eng Norconnect Inc
PRS Account Norconnect Inc
Verification Date October 2015