Parkinson's DiseaseNCT00862537
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.
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
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- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerry I Jacobson, PhD., DMD., Principal investigator, pico-tesla Magnetic Therapies, LLC
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
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
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.
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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?
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.