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

An observational study of Parkinson's Disease, run by pico-tesla Magnetic Therapies, LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease. Read more about this study

Who is it for?: Ages 30 to 82 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Resonator Device
Type of treatment: Medical device
How many people: 18 participants
Where: No sites listed yet
Study dates: Apr 2008to Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.

Who may be able to join

Prior participation in pico-tesla pilot studies: NCT00779155 \& NCT00863226
Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
Adequate contraceptive measures for female subjects
Capable of giving full written informed consent

Who cannot join

Not a participant in IRC#'s 07102 or 07021
No active brain tumors, strokes, hydrocephalus
Chronic pain not associated with PD
Any other condition which might prevent subject from comfortably sitting for 1.5 hours
Consumption of medications that can produce Parkinsonism type symptoms
Major psychiatric disturbance

Show all 25Show fewer

Epilepsy
HIv and other autoimmune disorders
Cancer within last 2 years
History of ECt
Diabetic neuropathy
Uncontrolled HTN
Advanced Pulmonary disease
Known heart conditions such as repetitive history of cardiac arrythmias
Previous surgeries for PD
Prosthetics comprised of ferrous materials
Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to heart muscle as a result of one or more heart attacks.
Pacemakers
Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator
Consumption of more than 21 alcoholic drinks per week
Pregnant, breast feeding or planning pregnancy
Developmental disability or cognitive impairment
Inability to maintain regular medication regime
Inability to abstain from partaking in new non-essential PD tx., or medications
Not willing to report physician mandated changes in medication and/or treatment

About this study

Official title: An Open-label Extension Study for Subjects Previously Treated Either in Pilot I or Pilot II Studies of the Application of Magnetic Fields Using the Resonator for the Treatment of Parkinson's Disease.

An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

Conditions: Parkinson's Disease
Being tested: Resonator Device
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Resonator DeviceDevice
active pico-tesla magnetic fields treatment for Parkinson's disease individuals

Study groups in NCT00862537
Study group	Role	What they receive
Active Resonator magnetic field therapy		Administration of active magnetic fields with the Resonator Device Receives: Device: Resonator Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
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).
Measured: baseline and 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Apr 2011

First posted17 Mar 2009 (estimated)
Study startApr 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00862537
Sponsor's protocol ID: PD Ext
Status last verified: Jun 2011
First submitted: 22 Oct 2008
Last updated: 8 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extension Study for Subjects Previously Treated Either in Pilot I or Pilot II Studies of the Application of Magnetic Fields Using the Resonator for the Treatment of Parkinson's Disease.
ClinicalTrials.gov ID: NCT00862537
Acronym / sponsor ID: PD Ext
Conditions: Parkinson's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Mar 2009 (estimated)
Results: Posted 8 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

Study design

Number of arms: 1

Arm	Type	Receives
Active Resonator magnetic field therapy	–	Device: Resonator DeviceAdministration of active magnetic fields with the Resonator Device

Who may qualify

Ages: 30 to 82 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.

Key inclusion criteria (6 listed)

Prior participation in pico-tesla pilot studies: NCT00779155 \& NCT00863226
Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
Adequate contraceptive measures for female subjects

Key exclusion criteria (25 listed)

Not a participant in IRC#'s 07102 or 07021
No active brain tumors, strokes, hydrocephalus
Chronic pain not associated with PD
Any other condition which might prevent subject from comfortably sitting for 1.5 hours
Consumption of medications that can produce Parkinsonism type symptoms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resonator Deviceactive pico-tesla magnetic fields treatment for Parkinson's disease individuals	Device	Active Resonator magnetic field therapy

Primary outcome

Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
Time frame: baseline and 11 months
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).

Results and safety

Results posted to the registry on 8 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Resontaor Device Therapy	18	11

Primary outcome: Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months

Time frame: baseline and 11 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	Active Resontaor Device Therapy n = 18
Value	4.96 (1.1)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Resontaor Device Therapy	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry I Jacobson, PhD., DMD. principal investigator

pico-tesla Magnetic Therapies, LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by pico-tesla Magnetic Therapies, LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months (time frame: baseline and 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00862537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.