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CompletedNCT00779155Updated Jul 12, 2011Results posted

Study of Magnetic Fields for Treatment of Parkinson's Disease

A Phase 2 interventional study of The Resonator and The Resonator control in Parkinson's Disease, sponsored by pico-tesla Magnetic Therapies, LLC. Completed at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-07-12.

Sponsored by pico-tesla Magnetic Therapies, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

pico-tesla Magnetic Therapies, LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • idiopathic PD with motor fluctuations of at least 3-4 hours daily., Subject on levodopa, subject is ambulatory, maintain regular med schedule, willing and able to abstain from new PD treatments, Able to demonstrate correct completion of PD diaries, non-demented, adequate contraceptive measures, capable of giving full written consent.

Exclusion criteria

Exclusion Criteria:

  • any factors that will prevent subject from completing full course of therapy with the resonator, any factors preventing subject from attending clinic in the "off" state, atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other neurologic or non-neurologic disorder which might affect the symptomatic expression of pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism, no psychiatric disturbance, Epilepsy, HIV, Cancer, History of ECT, Diabetic Neuropathy, Uncontrolled HTN, Advanced Pulmonary Disease, Known heart conditions such as cardiac arrythmias, previous PD surgical interventions, prosthetics comprised of ferrous metals, pacemakers, DBS, Uncontrolled, unstable or untreated medical illnesses, Consumption of more than 21 alcoholic drinks per week, Pregnant, breast feeding, developmental disability
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Placebo comparator
    Inactive Resonator Therapy

    Inactive magnetic resonance therapy

    Device: The Resonator control

  • Active comparator
    Active Resonator Therapy

    active magnetic resonance therapy

    Device: The Resonator

Interventions

  • DeviceThe Resonator

    active magnetic field therapy

  • DeviceThe Resonator control

    inactive magnetic field therapy with placebo fields

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.

    The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.

    Time frame: Baseline and 8 weeks

07

Results

Posted Jul 8, 2011

Participant flow

Participant flow — Overall Study
MilestoneInactive Resonator DeviceActive Resonator Device
Started66
Completed66
Not completed00

Outcome measures

PrimaryChange From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.

The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · scores on a scale
Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.
scores on a scaleInactive Resonator DeviceActive Resonator Device
Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.-1 ± .5-5 ± 1.2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inactive Resonator Device—0/6 (0%)0/6 (0%)
Active Resonator Device—0/6 (0%)0/6 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Inactive Resonator DeviceActive Resonator DeviceTotal
<=18 years000
Between 18 and 65 years011
>=65 years6511
Sex: Female, Male
Sex: Female, Male(Participants)Inactive Resonator DeviceActive Resonator DeviceTotal
Female033
Male639
08

Study locations

1 site
  • pico-tesla Magnetic Therapies
    Littleton, Colorado 80120, United States
09

References and documents

Publications

  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00779155
Lead sponsor
pico-tesla Magnetic Therapies, LLC
First posted
Oct 24, 2008
Start date
Aug 2007
Primary completion
Jun 2009
Completion
Jun 2009
Results posted
Jul 8, 2011
Last update
Jul 12, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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