Completed Research


PARKINSON’S DISEASE PILOT STUDY II

Title: Jacobson Resonator™ device: A double-blind, sham-stimulation controlled study of the application of magnetic fields using the Jacobson Resonator™ device for the treatment of Parkinson’s Disease.

Primary Purpose of the Study:

  • To gain more qualitative and quantitative data across a broader number of standardized scales to validate anecdotal data regarding benefits reported in Phase I study (i.e. Sleep, Fatigue, Depression, Sense of Smell, reduction in Off time, etc)
  • To further develop a treatment protocol with set output parameters that can effect general improvement in Parkinson's disease signs and symptoms.
  • To determine what, if any, “placebo effect” the intervention has and to develop a proper blinding mechanism for further studies.

 

 

 

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Test Results: Parkinson's Disease Pilot Study II

NOTE:
1. In all scales, the lower the number, the better the outcome.
2. N=6 per group
3. +/- delineates Standard Deviation

Standard Test or Scale BASELINE END POINT
WEEK 8

% CHANGE

p value
PDQ-39 Summary Index (SI)
Quality of Life

Treatment 20.01 +/-12.26< 11.61 +/-7.44 -42 p < .05
Control 24.52 +/-6.93 22.70 +/-6.84 -7
PDQ-39 (Mobility)
Treatment 25.0 +/-24.75 13.33 +/-13.48 -47 p < .05
Control 35.42 +/-12.49 33.33 +/-16.56 -6
PDQ-39 ADL
(Activities of Daily Living)
Treatment 25.00 +/-18.07 9.03 +/-6.67 -64 p < .05
Control 22.92 +/-5.74 20.83 +/-6.97 -9
PDQ-39 BD
(Bodily Discomfort/Pain)
Treatment 27.78 +/-15.52 19.45 +/-6.80 -30 p < .05
Control 22.22 +/-14.59 25.00 +/-20.41 +13
Beck Depression Inventory II
  (Depression)
Treatment 12.33 +/-4.76 6.6 +/-5.32 -47 p < .05
Control 12.17 +/-7.25 12.00 +/-4.94 -1
UPDRS II (ON)
Activities of Daily Living
Treatment 9.83 +/-6.34 4.33 +/-4.08 -56 p < .05
Control 11.67 +/-4.27 8.33 +/-2.25 -28
UPDRS III (ON) Motor
Treatment 23.50 +/-12.99 14.00 +/-7.56 -40 p = .054
Control 29.67 +/-7.94 23.83 +/-11.44 -20
FSS - Fatigue
Treatment 34.33 +/-10.23 26.67 +/-9.29 -22 p = .125
Control 35.17 +/-8.93 33.33 +/-9.65 -5

Click Here to View the Test Battery for PARKINSON’S DISEASE PILOT STUDY II


PARKINSON’S DISEASE PILOT STUDY I

Title: Jacobson Resonator™ device: Efficacy of the Application of Magnetic Fields to the Treatment of Parkinson’s Disease. IRC # 07021-02

Primary Purpose of the Study:

  • To gain a more formal idea - both qualitative and quantitative – of precisely how and to what extent the Resonator™ device may assist in alleviating the signs and symptoms of idiopathic Parkinson's disease when exercising greater control on the treated patient population and size and study outcome measures.
  • To develop a treatment protocol with set output parameters that can effect improvement in Parkinson's disease signs and symptoms universally.

Design: non-randomized, non-blinded single (treatment only) group study.

Subject Demographics:

  • Time frame: 2/9/07 – 5/5/07
  • 13 subjects total: 9 females; 4 males
  • All 13 were Caucasian
  • Avg age: 62 years (SD: 13 yrs; Range: 47-82 yrs)
  • Avg age of PD symptoms onset: 50.15 yrs (SD: 14.35 yrs; Range: 25-75 yrs)
  • Avg age of PD diagnosis: 52.31 yrs (SD: 13.37 yrs; Range: 27-75 yrs)
  • Avg length of time since PD symptom onset: 11.77 yrs (SD: 7.45 yrs; Range: 4-23 yrs)

Methodology: Treated with Resonator™ device for about 1.5 hours 3X per week for 3-5 weeks.

Outcome:

  Standard Test or Scale
BASELINE
3 WEEKS

% CHANGE

  UPDRS II (ADL)
13.92 +/- 4.59
6.77 +/- 3.42
-51%
  UPDRS III (motor)
32.46 +/- 10.09
21.08 +/- 8.83
-35%
  PDQ-39-SI
24.75 +/- 12.85
18.81 +/- 14.47
-24%

Notable improvements were also reported in the following areas:

  • Decreased fatigue/increased energy.
  • Improvement in the quality and quantity of sleep.
  • Ability to return and/or increase participation level in prior activities such as golf and driving.

Subjects were evaluated weekly post-treatment until their PD symptoms had returned to near pre-treatment levels. For almost all subjects, improvement in symptoms was substantially sustained for three weeks after treatment end before starting to diminish.


OTHER DISEASES/CONDITIONS
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Design: Randomized, double blind, placebo controlled

Subject Demographics:

  • Time frame: 10/07 – 4/08
  • 12 subjects total: 10 males; 2 females
  • 6 in treatment group, 6 in sham group
  • All 12 were Caucasian
  • Avg  age: 69 years (SD: 4.1 years; Range: 65-76 years)
  • Avg age of PD symptoms onset: 56.08 yrs (SD: 12.91 yrs; Range: 20-67 yrs)
  • Avg age of PD diagnosis: 61.33 yrs (SD: 4.83 yrs; Range: 55-69 yrs)
  • Avg length of time since PD symptoms onset: 13.17 yrs (SD: 11.00 yrs; Range: 3-25 yrs)

Methodology: Treated with Resonator™ device for about 1.5 hours 3X per week for 8 weeks.

Study Outcome:

  • The treatment group demonstrated improvement over the placebo group in multiple areas of evaluation in the pilot study.
  • Changes between Baseline and Endpoint (week 8) suggest a positive clinical impact across several motor and non-motor standard tests.
  • Testing was also conducted monthly over a 3-month washout period after endpoint, to assess retained benefits, if any. The treatment group demonstrated large benefits vs. control in several scales up to 2 months after their last treatment.
  • Broadly categorized, data suggest that improvements in motor symptoms scales showed improvement vs. placebo ranging from 20-53%. Improvements in non-motor symptoms scales ranged from 17-46%.
  • No serious adverse effects.
 

 

 
 

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Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.