Parkinson DiseaseNCT00023062
Transcranial Magnetic Stimulation in Parkinson's Disease
An observational study of Parkinson Disease and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use transcranial magnetic stimulation (TMS) to explore how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients:
- Patients with established, dopa-responsive PD, Hoehn and Yahr stage I-III, age 21 and older will be included.
- Patients will be recruited from the NINDS HMCS and ETB clinical programs and from the community.
- Healthy Controls:
- Healthy controls 21 and older will be recruited through the NIH Clinical Research Volunteer Program and from the community.
Who cannot join
- Exclusionary criteria will be: any significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
- Persons with surgically or traumatically implanted foreign bodies in the head (other than dental appliances of fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
- Patients:
- Patients with persistent "resting" tremor that precludes testing at rest may be excluded as well as any patient to whom the screening physician makes a judgment that withdrawal of medications poses a significant risk due to immobility or risk of falling.
- Patients on long-acting dopamine agonists will also be excluded.
- Patients in Hoehn and Yahr stage IV will also be excluded, since they are least likely to tolerate medication withdrawal and are also unlikely to be able to maintain muscle relaxation for TMS testing.
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- No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
- Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
- HEALTHY CONTROLS:
- Ages 21 and older will be recruited through the NIH Clinical Research Volunteer Program (CRVP) and from the community.
- All individuals will be processed through the CRVP before participating. Recruitment will be focused on optimizing age, sex, educational, and racial matching with patient group. Patients' spouses will be invited to participate.
- No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
- Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
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: TMS Measures in Parkinson's Disease
This study will use transcranial magnetic stimulation (TMS) to explore how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Activity in the motor cortex-the outer part of the brain-will be examined use TMS in patients with Parkinson's disease and in healthy volunteers.
Normal volunteers and patients with Parkinson's disease (stage I to III) 21 years of age and older may be eligible for this study.
Read more
All participants will have transcranial magnetic stimulation. For this procedure, an insulated wire coil is placed on the subject's scalp and a brief electrical current is passed through the coil. This creates a magnetic pulse that passes into the brain and generates very small electrical currents in the cortex, briefly disrupting the function of the brain cells in the stimulated area. This may cause muscle twitching or tingling in the face, jaw or limb. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes taped to the skin over the muscle. In most cases, the study will last less than 3 hours. Participants will also fill out questionnaires about aspects of personality and will be tested for their ability to perform certain cognitive (thinking) and movement tasks. Patients with Parkinson's disease will, in addition, be administered the Uniform Parkinson's Disease Rating Scale to measure disease severity.
Patients will be requested to stop all Parkinson's disease medications 12 hours before the study. They may resume medications immediately after the study. Patients who so wish may be admitted to the hospital the day or evening before the study while they are off medications and stay there until they feel ready to leave.
Read the detailed description
Paired pulse transcranial magnetic stimulation (TMS) provides a measure of the balance of inhibitory and facilitatory activity evokable in the motor cortex. Studies in several diverse disorders of basal ganglia outflow and cortical regulation show an alteration in the direction of decreased inhibition or increased facilitation. In general, these have been quite small, data from different interstimulus intervals have been pooled for analysis, and, therefore, disease and state-specific information may have been missed. A deeper understanding of what this technique can tell us about pathological and normal cortical regulation requires detailed studies within populations looking for correlations between physiological and clinical/behavioral variables and large, uniform, head-to-head comparisons between clinical populations. This proposal contains a project that combines the correlational and comparative approaches in Parkinson's disease and healthy individuals. Data from this project will then be comparable to future similar studies in other disorders.
- Conditions
- Parkinson Disease, Healthy
- Keywords
- Natural History, Motor Cortex, Behavior, Healthy Volunteers, Motor Control, Parkinson Disease, Parkinson's, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Parkinson Disease, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2001 (estimated)
- Study startAug 2001
- Study completionAug 2003
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
- Observational
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023062
- Sponsor's protocol ID
- 010240
- Other IDs
- 01-N-0240
- Status last verified
- Aug 2003
- First submitted
- 22 Aug 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.
PubMed 1695404Di Lazzaro V, Restuccia D, Oliviero A, Profice P, Ferrara L, Insola A, Mazzone P, Tonali P, Rothwell JC. Magnetic transcranial stimulation at intensities below active motor threshold activates intracortical inhibitory circuits. Exp Brain Res. 1998 Mar;119(2):265-8. doi: 10.1007/s002210050341.
PubMed 9535577Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.
PubMed 10636140
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
- TMS Measures in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00023062
- Acronym / sponsor ID
- 010240
- Conditions
- Parkinson Disease, Healthy
- Keywords
- Natural History, Motor Cortex, Behavior, Healthy Volunteers, Motor Control, Parkinson Disease, Parkinson's, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Aug 2001
- Study completion
- Aug 2003
- First posted
- 23 Aug 2001 (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 use transcranial magnetic stimulation (TMS) to explore how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Activity in the motor cortex-the outer part of the brain-will be examined use TMS in patients with Parkinson's disease and in healthy volunteers.
Normal volunteers and patients with Parkinson's disease (stage I to III) 21 years of age and older may be eligible for this study.
All participants will have transcranial magnetic stimulation. For this procedure, an insulated wire coil is placed on the subject's scalp and a brief electrical current is passed through the coil. This creates a magnetic pulse that passes into the brain and generates very small electrical currents in the cortex, briefly disrupting the function of the brain cells in the stimulated area. This may cause muscle twitching or tingling in the face, jaw or limb. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes taped to the skin over the muscle. In most cases, the study will last less than 3 hours. Participants will also fill out questionnaires about aspects of personality and will be tested for their ability to perform certain cognitive (thinking) and movement tasks. Patients with Parkinson's disease will, in addition, be administered the Uniform Parkinson's Disease Rating Scale to measure disease severity.
Patients will be requested to stop all Parkinson's disease medications 12 hours before the study. They may resume medications immediately after the study. Patients who so wish may be admitted to the hospital the day or evening before the study while they are off medications and stay there until they feel ready to leave.
Detailed description
Paired pulse transcranial magnetic stimulation (TMS) provides a measure of the balance of inhibitory and facilitatory activity evokable in the motor cortex. Studies in several diverse disorders of basal ganglia outflow and cortical regulation show an alteration in the direction of decreased inhibition or increased facilitation. In general, these have been quite small, data from different interstimulus intervals have been pooled for analysis, and, therefore, disease and state-specific information may have been missed. A deeper understanding of what this technique can tell us about pathological and normal cortical regulation requires detailed studies within populations looking for correlations between physiological and clinical/behavioral variables and large, uniform, head-to-head comparisons between clinical populations. This proposal contains a project that combines the correlational and comparative approaches in Parkinson's disease and healthy individuals. Data from this project will then be comparable to future similar studies in other disorders.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with established, dopa-responsive PD, Hoehn and Yahr stage I-III, age 21 and older will be included.
- Patients will be recruited from the NINDS HMCS and ETB clinical programs and from the community.
- Healthy controls 21 and older will be recruited through the NIH Clinical Research Volunteer Program and from the community.
Key exclusion criteria (13 listed)
- Exclusionary criteria will be: any significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
- Persons with surgically or traumatically implanted foreign bodies in the head (other than dental appliances of fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
- Patients with persistent "resting" tremor that precludes testing at rest may be excluded as well as any patient to whom the screening physician makes a judgment that withdrawal of medications poses a significant risk due to immobility or risk of falling.
- Patients on long-acting dopamine agonists will also be excluded.
- Patients in Hoehn and Yahr stage IV will also be excluded, since they are least likely to tolerate medication withdrawal and are also unlikely to be able to maintain muscle relaxation for TMS testing.
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 4 Mar 2008.
- Background: PubMed 1695404DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.
- Background: PubMed 9535577Di Lazzaro V, Restuccia D, Oliviero A, Profice P, Ferrara L, Insola A, Mazzone P, Tonali P, Rothwell JC. Magnetic transcranial stimulation at intensities below active motor threshold activates intracortical inhibitory circuits. Exp Brain Res. 1998 Mar;119(2):265-8. doi: 10.1007/s002210050341.
- Background: PubMed 10636140Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.
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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?
An observational study of Parkinson Disease and Healthy, 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 5 inclusion and 13 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.
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 NCT00023062, 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.