Parkinson's DiseaseNCT00841464
Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
An observational study of Parkinson's Disease, run by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia at 1 site in United States.
Trial summary
The purpose of this research study is to test the usefulness of external magnetic stimulation (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease (PD). Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA Medical Center. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2011
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Parkinson's disease will be recruited ONLY at the Parkinson's Disease Research, Education, and Clinical Center (PADRECC) of the Philadelphia VA Medical Center.
Who may be able to join
- 40 to 80 years of age
- Diagnosis of possible or probable PD by the UK Brain Bank clinical diagnostic criteria
- Stable anti-Parkinsonian medical regimen for at least 30 days prior to enrollment
- Hoehn \& Yahr Scale score of I to III
- No evidence of secondary or atypical Parkinsonism on MRI test in the past year
- Subjects are capable of giving informed consent
Who cannot join
- Contraindications to MRI (e.g. cardiac pacemaker, claustrophobia, metal fragments or hardware within the orbit or cranium)
- History of stroke or TIA within the past year
- Dementia defined as a MMSE score < 25
- Status post deep brain stimulation surgery
- Unstable medical conditions that would likely prevent the subject from completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prospective Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
The purpose of this research study is to test the usefulness of external magnetic stimulation (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease (PD).
Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to receive either active external magnetic stimulation or fake stimulation. The external magnetic stimulation is delivered by wearing a helmet that is embedded with many small circuits which produce a very small magnetic field around the head. The helmet is to be worn daily for two minutes immediately before bedtime for three months in a row. The helmet is for investigational use only and has not been approved for use by the FDA.
Read the detailed description
Current research seeks to provide a drug-free, non-invasive and non-toxic therapy for Parkinson's disease through transcranial magnetic stimulation (TMS) in the form of picoTesla magnetic therapy (pTMT). This therapy consists of an electronic device that emits magnetic flux densities that are more than ten million times lower than the magnetic flux density of the earth's magnetic field. Repetitive transcranial magnetic stimulation (rTMS) therapy aims to manipulate overall quality of life by improving motor function, as well as cognitive and neuropsychiatric symptoms such as depression.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Transcranial Magnetic Stimulation
- Medical subject headings
- Parkinson Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startMar 2009
- Study completionMay 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
- Sponsor type
- US federal agency
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- John E Duda, M.D., Principal investigator, Parkinson's Disease Research, Education, and Clinical Center (PADRECC), PhiladelphiaTimothy Roberts, Ph.D., Principal investigator, Department of Radiology, The Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841464
- Sponsor's protocol ID
- 1EA-0000071
- Status last verified
- Jul 2012
- First submitted
- 10 Feb 2009
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00841464
- Acronym / sponsor ID
- 1EA-0000071
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Parkinson's Disease Research, Education, and Clinical Center, PhiladelphiaUS federal agency
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Mar 2009
- Study completion
- May 2011 (actual)
- First posted
- 11 Feb 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 research study is to test the usefulness of external magnetic stimulation (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease (PD).
Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to receive either active external magnetic stimulation or fake stimulation. The external magnetic stimulation is delivered by wearing a helmet that is embedded with many small circuits which produce a very small magnetic field around the head. The helmet is to be worn daily for two minutes immediately before bedtime for three months in a row. The helmet is for investigational use only and has not been approved for use by the FDA.
Detailed description
Current research seeks to provide a drug-free, non-invasive and non-toxic therapy for Parkinson's disease through transcranial magnetic stimulation (TMS) in the form of picoTesla magnetic therapy (pTMT). This therapy consists of an electronic device that emits magnetic flux densities that are more than ten million times lower than the magnetic flux density of the earth's magnetic field. Repetitive transcranial magnetic stimulation (rTMS) therapy aims to manipulate overall quality of life by improving motor function, as well as cognitive and neuropsychiatric symptoms such as depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Parkinson's disease will be recruited ONLY at the Parkinson's Disease Research, Education, and Clinical Center (PADRECC) of the Philadelphia VA Medical Center.
Key inclusion criteria (6 listed)
- 40 to 80 years of age
- Diagnosis of possible or probable PD by the UK Brain Bank clinical diagnostic criteria
- Stable anti-Parkinsonian medical regimen for at least 30 days prior to enrollment
- Hoehn \& Yahr Scale score of I to III
- No evidence of secondary or atypical Parkinsonism on MRI test in the past year
Key exclusion criteria (5 listed)
- Contraindications to MRI (e.g. cardiac pacemaker, claustrophobia, metal fragments or hardware within the orbit or cranium)
- History of stroke or TIA within the past year
- Dementia defined as a MMSE score < 25
- Status post deep brain stimulation surgery
- Unstable medical conditions that would likely prevent the subject from completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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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.
John E Duda, M.D. principal investigator
Parkinson's Disease Research, Education, and Clinical Center (PADRECC), Philadelphia
Timothy Roberts, Ph.D. principal investigator
Department of Radiology, The Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia at 1 site 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 6 inclusion and 5 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Jul 2012.