Parkinson DiseasePhase 1/2NCT00977184
50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
A Phase 1/2 study testing 50 HZ Repetitive TMS in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic field which induces an electric current in the brain leading to a change in the activity of brain cells. There are different effects on the brain with different rates of stimulation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 50 HZ Repetitive TMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2010
- Phase
- Phase 1/2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 40 to 80 years with DOPA-responsive PD
- Hoehn and Yahr grade of 2 to 4 while off
- Must be on a regimen including levodopa
- Total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
- problems with walking and gait time for a 10-meter distance greater than six seconds or more
Who cannot join
- Any active psychiatric disease
- History of seizures and epilepsy
- Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for SSRI
- Pallidotomy, implanted electrodes and generator for deep brain stimulation
- Pregnancy
- Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during TEP.
Show all 11Show fewer
- Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
- Dementia as assessed by the Folstein's Mini-Mental Test Examination (MMSE less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview)
- Unable to walk a 10-meter distance.
- More than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in UPDRS item 13), history of fall(s) with significant injuries, absence of postural response in the on and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in UPDRS item 30)
- Pregnancy is unusual in patients with PD, grade 2-4. Urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to starting the 50 Hz rTMS and also at the initial interview after signing the consent form. Women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Controlled Study of 50 Hz Repetitive Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease
Background:
- In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic field which induces an electric current in the brain leading to a change in the activity of brain cells. There are different effects on the brain with different rates of stimulation. In a previous study in people with Parkinson's disease, repetitive TMS (rTMS) given at a particular rate temporarily improved their ability to walk. A faster rate of rTMS may be more effective in treating symptoms than the rate originally used.
- This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the people in this study will have active rTMS; the other half will have no brain stimulation with rTMS.
Read more
Objectives:
- To see if a faster rate of transcranial magnetic stimulation is a more effective treatment for the symptoms of Parkinson's disease than the slower rates that have been studied.
Eligibility:
- Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate Parkinson's disease.
- Participants must currently be taking Sinemet or dopamine agonists drugs (e.g., bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and rotigotine), and are willing to continue their same treatments for the duration of the study.
Design:
- This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks. Participants can also be admitted and stay as an inpatient in the NIH Clinical Center for the entire study period (for the 10 visits during the first weeks and the follow-up visit a month later).
- Initial visit will consist of a physical examination; a test of participants' time to walk 10 meters; and questions about memory, mood, and quality of life. Participants should not take Parkinson's disease medications for 12 hours before this visit; once the examinations and tests are complete, participants will be able to take the medications. Researchers will repeat the tests 1 hour after participants take the medication.
- TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation session will last half an hour. Half of the participants will receive active TMS; the other half will receive sham TMS.
- The first 10 participants will have additional tests to study the safety of rapid TMS in patients with Parkinson's disease.
- A day after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication as in the first assessment and respond to questions about mood, memory, and quality of life.
- One month after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication.
Read the detailed description
Objective:
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease (PD) patients.
Study population:
Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine agonists) and have gait problems.
Design:
This is a randomized, double-blind, placebo (sham)-controlled study of 26 patients with PD in 2 groups (real versus sham stimulation). The study involves performance (8 interventions) of 50 Hz rTMS with large circular coil over the motor cortex on both sides of the brain. Assessment of PD symptoms with standard tests of motor function will be performed over a one-month period.
Outcome measure:
The primary endpoint include the changes in gait speed as assessed by the time it takes to walk 10 meters and the changes in bradykinesia as assessed by measuring the time it takes to do 10 combined hand and arm movements.
Secondary endpoints include the changes in the total, motor and activities of daily living Unified Parkinson's Disease Rating Scale (UPDRS) score.
- Conditions
- Parkinson Disease
- Being tested
- 50 HZ Repetitive TMS, Sham rTMS
- Keywords
- Parkinson's Disease, Transcranial Magnetic Stimulation (TMS), Treatment Study, PD, Parkinson 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.
50 HZ Repetitive TMSProcedure or surgery
Sham rTMSProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS | Experimental | Not described Receives: Procedure: 50 HZ Repetitive TMS |
| Sham rTMS | Sham comparator | Not described Receives: Procedure: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.
Measured: Baseline, 1 day post rTMS
Secondary outcomes (4)
Bradykinesia
Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.
Measured: Baseline, 1 day post rTMS
Total UPDRS Score
The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.
Measured: Baseline, 1 day post rTMS
Motor UPDRS
The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.
Measured: Baseline, 1 day post rTMS
Activities of Daily Living UPDRS
The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).
Measured: Baseline, 1 day post rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Mark Hallett, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977184
- Sponsor's protocol ID
- 090221
- Other IDs
- 09-N-0221
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2009
- Last updated
- 27 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 9437571Baudewig J, Siebner HR, Bestmann S, Tergau F, Tings T, Paulus W, Frahm J. Functional MRI of cortical activations induced by transcranial magnetic stimulation (TMS). Neuroreport. 2001 Nov 16;12(16):3543-8. doi: 10.1097/00001756-200111160-00034.
PubMed 11733708Belmaker 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 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of 50 Hz Repetitive Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00977184
- Acronym / sponsor ID
- 090221
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Transcranial Magnetic Stimulation (TMS), Treatment Study, PD, Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Posted 27 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic field which induces an electric current in the brain leading to a change in the activity of brain cells. There are different effects on the brain with different rates of stimulation. In a previous study in people with Parkinson's disease, repetitive TMS (rTMS) given at a particular rate temporarily improved their ability to walk. A faster rate of rTMS may be more effective in treating symptoms than the rate originally used.
- This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the people in this study will have active rTMS; the other half will have no brain stimulation with rTMS.
Objectives:
- To see if a faster rate of transcranial magnetic stimulation is a more effective treatment for the symptoms of Parkinson's disease than the slower rates that have been studied.
Eligibility:
- Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate Parkinson's disease.
- Participants must currently be taking Sinemet or dopamine agonists drugs (e.g., bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and rotigotine), and are willing to continue their same treatments for the duration of the study.
Design:
- This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks. Participants can also be admitted and stay as an inpatient in the NIH Clinical Center for the entire study period (for the 10 visits during the first weeks and the follow-up visit a month later).
- Initial visit will consist of a physical examination; a test of participants' time to walk 10 meters; and questions about memory, mood, and quality of life. Participants should not take Parkinson's disease medications for 12 hours before this visit; once the examinations and tests are complete, participants will be able to take the medications. Researchers will repeat the tests 1 hour after participants take the medication.
- TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation session will last half an hour. Half of the participants will receive active TMS; the other half will receive sham TMS.
- The first 10 participants will have additional tests to study the safety of rapid TMS in patients with Parkinson's disease.
- A day after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication as in the first assessment and respond to questions about mood, memory, and quality of life.
- One month after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication.
Detailed description
Objective:
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease (PD) patients.
Study population:
Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine agonists) and have gait problems.
Design:
This is a randomized, double-blind, placebo (sham)-controlled study of 26 patients with PD in 2 groups (real versus sham stimulation). The study involves performance (8 interventions) of 50 Hz rTMS with large circular coil over the motor cortex on both sides of the brain. Assessment of PD symptoms with standard tests of motor function will be performed over a one-month period.
Outcome measure:
The primary endpoint include the changes in gait speed as assessed by the time it takes to walk 10 meters and the changes in bradykinesia as assessed by measuring the time it takes to do 10 combined hand and arm movements.
Secondary endpoints include the changes in the total, motor and activities of daily living Unified Parkinson's Disease Rating Scale (UPDRS) score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Experimental | Procedure: 50 HZ Repetitive TMS |
| Sham rTMS | Sham comparator | Procedure: Sham rTMS |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 40 to 80 years with DOPA-responsive PD
- Hoehn and Yahr grade of 2 to 4 while off
- Must be on a regimen including levodopa
- Total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
- problems with walking and gait time for a 10-meter distance greater than six seconds or more
Key exclusion criteria (11 listed)
- Any active psychiatric disease
- History of seizures and epilepsy
- Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for SSRI
- Pallidotomy, implanted electrodes and generator for deep brain stimulation
- Pregnancy
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 |
|---|---|---|
| 50 HZ Repetitive TMS | Procedure or surgery | Real rTMS |
| Sham rTMS | Procedure or surgery | Sham rTMS |
Primary outcome
Gait Speed
Time frame: Baseline, 1 day post rTMS
Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.
4 secondary outcomes
Bradykinesia
Time frame: Baseline, 1 day post rTMS
Total UPDRS Score
Time frame: Baseline, 1 day post rTMS
Motor UPDRS
Time frame: Baseline, 1 day post rTMS
Activities of Daily Living UPDRS
Time frame: Baseline, 1 day post rTMS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 11733708Baudewig J, Siebner HR, Bestmann S, Tergau F, Tings T, Paulus W, Frahm J. Functional MRI of cortical activations induced by transcranial magnetic stimulation (TMS). Neuroreport. 2001 Nov 16;12(16):3543-8. doi: 10.1097/00001756-200111160-00034.
- 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 1/2 study testing 50 HZ Repetitive TMS 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 5 inclusion and 11 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 27 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 27 Dec 2012). 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?
Gait Speed (time frame: Baseline, 1 day post rTMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00977184, 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 27 Dec 2012.