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Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

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: NCT00862537
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC

Study Type Observational
Condition Parkinson's Disease
Intervention Device: Resonator Device
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Resontaor Device Therapy
Hide Arm/Group Description active pico-tesla magnetic fields Resonator device therapy
Period Title: Overall Study
Started 18
Completed 11
Not Completed 7
Arm/Group Title Active Resontaor Device Therapy
Hide Arm/Group Description active pico-tesla magnetic fields Resonator device therapy
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  61.1%
>=65 years
7
  38.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
5
  27.8%
Male
13
  72.2%
1.Primary Outcome
Title Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
Hide Description The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).
Time Frame baseline and 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Resontaor Device Therapy
Hide Arm/Group Description:
active pico-tesla magnetic fields Resonator device therapy
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.96  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Resontaor Device Therapy
Hide Arm/Group Description active pico-tesla magnetic fields Resonator device therapy
All-Cause Mortality
Active Resontaor Device Therapy
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Active Resontaor Device Therapy
Affected / at Risk (%)
Total   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Resontaor Device Therapy
Affected / at Risk (%)
Total   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allen S. Braswell CEO
Organization: Pico-Tesla Magnetic Therapies, LLC
Phone: 303 795-3222
EMail: abraswell@pico-tesla.com
Layout table for additonal information
Responsible Party: pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00862537    
Other Study ID Numbers: PD Ext
First Submitted: October 22, 2008
First Posted: March 17, 2009
Results First Submitted: May 13, 2011
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011