Parkinson DiseasePhase 2NCT00029666
Study of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease
A Phase 2 study testing Neopulse Magnetic Stimulator in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to change the electrical activity of the nerve cells in the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neopulse Magnetic Stimulator
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2005
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women aged forty to eighty five years with DOPA-responsive, akinetic-rigid PD.
- Patients who have not participated in Human Motor Control Section (HMCS) protocols for PD in the past will be interviewed and examined by either the PI or a Brain Stimulation Unit (BSU) or HMCS physician in order to establish the diagnosis of PD and rule out any neurologic condition.
- Only patients with a Hoehn and Yahr grade of 3 to 5 while "off" will be accepted.
- Patients must be on a regimen including levodopa, and have a total dose of medication equal to more than 375 mg of levodopa equivalent including their dopamine agonist agents.
- Patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be 5 seconds or more.
- Any patient whose record does not contain a neurological examination from the past year will be reexamined before enrollment. The study will be explained and informed consent obtained by a protocol investigator.
Who cannot join
- Any significant medical or psychiatric illness (other than PD), pregnancy (urine sample for the pregnancy test will be obtained prior to the rTMS start, at the day of the initial interview and signing the consent form), history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
- Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medication pump, metal plate in the skull, and metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
- Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
- Mentally impaired patients having no capacity to provide their own consent will be excluded from the study. The physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview. No psychological tests will be used. Formal reevaluation will not be done.
- Children are excluded since Parkinson's disease is not, generally, a disorder of children.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Placebo Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to change the electrical activity of the nerve cells in the brain. It has been proposed as a treatment for brain disorders, including Parkinson's disease. In preliminary studies, some patients' symptoms improved; in some they worsened temporarily, and some showed no change.
Patients between 40 and 80 years of age with moderately severe Parkinson's disease, whose main problem is slowness of movement and stiffness, may be eligible for this study.
Read more
Participants will be randomly assigned to one of two treatment groups: one will receive rTMS to parts of the brain involved in controlling movement; the other will receive sham, or placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will take their Parkinson's disease medications during the study, but will stop taking the medicines for 4 to 5 hours before one of the sessions.
For rTMS, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The pulses are delivered in trains, or short bursts, lasting 1 second each. There will be 48 trains for a total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the scalp or face and may also cause small movements of the limbs.
Just before and after each rTMS session, patients will have a neurologic examination, including an evaluation of walking. Their motor function tests will be recorded on videotape to document possible improvement and to allow physicians to rate the improvement. The physicians will not know which patients are receiving actual rTMS and which are receiving sham treatment. Ratings before the first and after the last rTMS sessions will be more detailed.
Read the detailed description
The treatment of Parkinson's disease (PD) needs further improvement, particularly in the area of gait and freezing. A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced small effects on bradykinesia in drug free patients in limited trials. We hypothesize that rTMS will have a beneficial effect on gait and freezing in medicated patients, and propose to test this in a controlled trial. Specifically, we propose to look at the effect of 25 Hz stimulation since this type of stimulation has been shown to increase the excitability of the cerebral cortex. Over a one-year period, we will enroll 40 adults with PD and evaluate the effects 8 treatments over a period of 4 weeks. We will investigate effects on the motor cortex and the dorsolateral prefrontal cortex since both of these regions may be underactivated in PD and recent data suggest a change in diencephalic dopamine function with rTMS of the prefrontal cortex. Symptoms will be evaluated with standard tests of motor function including the Unified Parkinson's Disease Rating Scale and specific tests of gait and freezing. We will look for acute effects of stimulation and for cumulative effects.
- Conditions
- Parkinson Disease
- Being tested
- Neopulse Magnetic Stimulator
- Keywords
- Motor Cortex, Sham Stimulation, Prefrontal Cortex, Brain Stimulation, Gait, Parkinson, Parkinson's, PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neopulse Magnetic StimulatorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2002 (estimated)
- Study startJan 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029666
- Sponsor's protocol ID
- 020105
- Other IDs
- 02-N-0105
- Status last verified
- Mar 2005
- First submitted
- 17 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Aarsland D, Larsen JP, Waage O, Langeveld JH. Maintenance electroconvulsive therapy for Parkinson's disease. Convuls Ther. 1997 Dec;13(4):274-7.
PubMed 9437571Balldin J, Granerus AK, Lindstedt G, Modigh K, Walinder J. Neuroendocrine evidence for increased responsiveness of dopamine receptors in humans following electroconvulsive therapy. Psychopharmacology (Berl). 1982;76(4):371-6. doi: 10.1007/BF00449127.
PubMed 6812112Belmaker RH, Grisaru N. Magnetic stimulation of the brain in animal depression models responsive to ECS. J ECT. 1998 Sep;14(3):194-205.
PubMed 9773358
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00029666
- Acronym / sponsor ID
- 020105
- Conditions
- Parkinson Disease
- Keywords
- Motor Cortex, Sham Stimulation, Prefrontal Cortex, Brain Stimulation, Gait, Parkinson, Parkinson's, PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Mar 2005
- First posted
- 18 Jan 2002 (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.
This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to change the electrical activity of the nerve cells in the brain. It has been proposed as a treatment for brain disorders, including Parkinson's disease. In preliminary studies, some patients' symptoms improved; in some they worsened temporarily, and some showed no change.
Patients between 40 and 80 years of age with moderately severe Parkinson's disease, whose main problem is slowness of movement and stiffness, may be eligible for this study.
Participants will be randomly assigned to one of two treatment groups: one will receive rTMS to parts of the brain involved in controlling movement; the other will receive sham, or placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will take their Parkinson's disease medications during the study, but will stop taking the medicines for 4 to 5 hours before one of the sessions.
For rTMS, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The pulses are delivered in trains, or short bursts, lasting 1 second each. There will be 48 trains for a total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the scalp or face and may also cause small movements of the limbs.
Just before and after each rTMS session, patients will have a neurologic examination, including an evaluation of walking. Their motor function tests will be recorded on videotape to document possible improvement and to allow physicians to rate the improvement. The physicians will not know which patients are receiving actual rTMS and which are receiving sham treatment. Ratings before the first and after the last rTMS sessions will be more detailed.
Detailed description
The treatment of Parkinson's disease (PD) needs further improvement, particularly in the area of gait and freezing. A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced small effects on bradykinesia in drug free patients in limited trials. We hypothesize that rTMS will have a beneficial effect on gait and freezing in medicated patients, and propose to test this in a controlled trial. Specifically, we propose to look at the effect of 25 Hz stimulation since this type of stimulation has been shown to increase the excitability of the cerebral cortex. Over a one-year period, we will enroll 40 adults with PD and evaluate the effects 8 treatments over a period of 4 weeks. We will investigate effects on the motor cortex and the dorsolateral prefrontal cortex since both of these regions may be underactivated in PD and recent data suggest a change in diencephalic dopamine function with rTMS of the prefrontal cortex. Symptoms will be evaluated with standard tests of motor function including the Unified Parkinson's Disease Rating Scale and specific tests of gait and freezing. We will look for acute effects of stimulation and for cumulative effects.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged forty to eighty five years with DOPA-responsive, akinetic-rigid PD.
- Patients who have not participated in Human Motor Control Section (HMCS) protocols for PD in the past will be interviewed and examined by either the PI or a Brain Stimulation Unit (BSU) or HMCS physician in order to establish the diagnosis of PD and rule out any neurologic condition.
- Only patients with a Hoehn and Yahr grade of 3 to 5 while "off" will be accepted.
- Patients must be on a regimen including levodopa, and have a total dose of medication equal to more than 375 mg of levodopa equivalent including their dopamine agonist agents.
- Patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be 5 seconds or more.
Key exclusion criteria (5 listed)
- Any significant medical or psychiatric illness (other than PD), pregnancy (urine sample for the pregnancy test will be obtained prior to the rTMS start, at the day of the initial interview and signing the consent form), history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
- Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medication pump, metal plate in the skull, and metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
- Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
- Mentally impaired patients having no capacity to provide their own consent will be excluded from the study. The physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview. No psychological tests will be used. Formal reevaluation will not be done.
- Children are excluded since Parkinson's disease is not, generally, a disorder of children.
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 |
|---|---|---|
| Neopulse Magnetic Stimulator | Device | – |
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 4 Mar 2008.
- Background: PubMed 9437571Aarsland D, Larsen JP, Waage O, Langeveld JH. Maintenance electroconvulsive therapy for Parkinson's disease. Convuls Ther. 1997 Dec;13(4):274-7.
- Background: PubMed 6812112Balldin J, Granerus AK, Lindstedt G, Modigh K, Walinder J. Neuroendocrine evidence for increased responsiveness of dopamine receptors in humans following electroconvulsive therapy. Psychopharmacology (Berl). 1982;76(4):371-6. doi: 10.1007/BF00449127.
- Background: PubMed 9773358Belmaker RH, Grisaru N. Magnetic stimulation of the brain in animal depression models responsive to ECS. J ECT. 1998 Sep;14(3):194-205.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neopulse Magnetic Stimulator in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 4 Mar 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT00029666, which also lists 3 linked publications.
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 4 Mar 2008.