Text Size

Study of Magnetic Fields for Treatment of Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT00779155
First received: October 22, 2008
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
Results First Received: May 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Device: The Resonator
Device: The Resonator control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inactive Resonator Device inactive magnetic fields with placebo fields
Active Resonator Device Active pico-tesla magnetic fields

Participant Flow:   Overall Study
    Inactive Resonator Device     Active Resonator Device  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Inactive Resonator Device inactive magnetic fields with placebo fields
Active Resonator Device Active pico-tesla magnetic fields
Total Total of all reporting groups

Baseline Measures
    Inactive Resonator Device     Active Resonator Device     Total  
Number of Participants  
[units: participants]
 		  6     6     12  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     0     1     1  
>=65 years     6     5     11  
Gender  
[units: participants]
 		     
Female     0     3     3  
Male     6     3     9  



  Outcome Measures

1.  Primary:   Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.   [ Time Frame: Baseline and 8 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Allen S. Braswell CEO
Organization: Pico-Tesla Magnetic Therapies, LLC
phone: 303-795-3222
e-mail: abraswell@pico-tesla.com


Publications of Results:
O. Klepitskaya, R. Kumar, Efficacy and Safety of Low Level Electromagnetic Fields Treatment in Parkinson's Disease. Movement Disorders; Vol. 23, No. 11, 2008, pp. 1628-1637


Responsible Party: pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00779155     History of Changes
Other Study ID Numbers: PD pilot 2
Study First Received: October 22, 2008
Results First Received: May 13, 2011
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board