Parkinson's DiseasePhase 3NCT00863226
Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
A Phase 3 study testing Resonator Device in people with Parkinson's Disease and Quality of Life, run by pico-tesla Magnetic Therapies, LLC at 6 sites in United States.
Trial summary
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease, Quality of Life
- What is being tested?
- Resonator Device
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2009to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease
- Stable optimized anti-PD drugs for at least 4 weeks
- PDQ-39 Summary Index between 15 and 45
- Ambulatory
- Willing to maintain regular medication regime throughout study
- Able to abstain from starting in new treatments to improve PD symptoms during course of study.
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- No prior surgical interventions for Parkinson's Disease
- Non-demented
- Minimum of 30 years of age, but not older than 85
- Capable of giving full written consent
Who cannot join
- Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
- Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
- Consumption of medications that can produce drug induced parkinsonism
- Chronic pain not associated with PD
- Current or past history of major psychiatric disturbance
- No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
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- Chronic fatigue
- Epilepsy or history of epilepsy
- Seizures or taking medication for epilepsy
- HIV or other autoimmune disorders
- History of ECT
- Uncontrolled hypertension
- Advanced pulmonary disease
- Unstable cardiac disease
- Prior surgical interventions for Parkinson's disease
- Prosthetics or implants comprised of ferrous metals
- Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
- Pregnant, breast feeding or planning pregnancy prior to study end
- Dementia, developmental disability, psychiatric disorder or other cognitive impairment
- Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health Sciences Center
Aurora, Colorado
Mile High Research Center
Denver, Colorado, 80218
CNI Movement Disorders Center
Englewood, Colorado, 80113
Detroit Clinical Research Center
Novi, Michigan, 48337
Suncoast Neuroscience Associates
Saint Petersbury, Florida, 33713
University of South Florida
Tampa, Florida, 33612
About this study
Official title: A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.
Read the detailed description
This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.
- Conditions
- Parkinson's Disease, Quality of Life
- Being tested
- Resonator Device
- Keywords
- Quality of Life issues in Parkinson's disease
- 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
Application of Magnetic Fields Using the Resonator Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PDQ-39 single index score
Measured: 8 weeks
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 startMar 2009
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajeev Kumar, MD, Principal investigatorJack Klapper, MD, Principal investigatorStephen H Schechter, MD, Principal investigatorOlga Klepitskaya, MD, Principal investigatorSteven Cohen, MD, Principal investigatorRobert A Hauser, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863226
- Sponsor's protocol ID
- 09026-01
- Status last verified
- Dec 2011
- First submitted
- 13 Mar 2009
- Last updated
- 14 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT00863226
- Acronym / sponsor ID
- 09026-01
- Conditions
- Parkinson's Disease, Quality of Life
- Keywords
- Quality of Life issues in Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.
Detailed description
This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Idiopathic Parkinson's Disease
- Stable optimized anti-PD drugs for at least 4 weeks
- PDQ-39 Summary Index between 15 and 45
- Ambulatory
- Willing to maintain regular medication regime throughout study
Key exclusion criteria (20 listed)
- Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
- Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
- Consumption of medications that can produce drug induced parkinsonism
- Chronic pain not associated with PD
- Current or past history of major psychiatric disturbance
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 DeviceApplication of Magnetic Fields Using the Resonator Device | Device | – |
Primary outcome
Change in PDQ-39 single index score
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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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.
Rajeev Kumar, MD principal investigator
Jack Klapper, MD principal investigator
Stephen H Schechter, MD principal investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resonator Device in people with Parkinson's Disease and Quality of Life, run by pico-tesla Magnetic Therapies, LLC at 6 sites in United States.
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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 PDQ-39 single index score (time frame: 8 weeks). 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 14 Dec 2011.