DystoniaNCT01792336
Transcranial Magnetic Stimulation for Focal Hand Dystonia
An observational study of Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2013to 19 Feb 2019
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of focal hand dystonia (patients only).
- Between age 18 and 70 years.
- Able to give informed consent
- Right handed
- Agrees to not drink caffeine or alcohol for 48 hours before study session.
- No open scalp wounds or scalp infections.
Who cannot join
- Has used illegal drugs within the past 6 months based on history, including but not limited to marijuana, cocaine, methamphetamine, etc. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam (other than dystonia in patient group)
- Has had a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.
- Has major depression or any major mental disorders (axis I disorders)
- Has a neurologic disorder other than dystonia
Show all 12Show fewer
- Has had a head injury where there was a loss of consciousness for more than a few seconds.
- Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed.
- Has known hearing loss.
- Pregnancy
- Taking any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, and sympathomimetics.
- Has excessive daytime sleepiness as indicated by a score of 10 or higher on the Epworth Sleepiness Scale.
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: Gamma Frequency Transcranial Magnetic Stimulation in Dystonia
Background:
- The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.
- Focal hand dystonia, also known as "writer's cramp" or "musician's cramp," is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia.
Read more
Objectives:
- To better understand brain rhythms involved in focal hand dystonia.
Eligibility:
- Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.
- Healthy right-handed volunteers between 18 and 60 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.
- Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held on their scalp. A brief electrical current will pass through the coil. It creates a magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and left sides of the head. This will help find the spot that activates the finger muscles, and see how much TMS is needed.
- In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated magnetic pulses delivered in short bursts. There will be four pulses in each burst. Participants will have multiple bursts during the test. This test will look at how the muscles of the hand and fingers respond to brain stimulation.
- Treatment for focal hand dystonia will not be provided as part of this study.
Read the detailed description
Objectives:
The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using transcranial magnetic stimulation (TMS). The study may reveal new information about the role of gamma frequency oscillations in cortical facilitation in dystonia patients versus healthy volunteer subjects.
The findings of this study may also help to determine if abnormal gamma frequency facilitation might become a potential diagnostic tool for dystonia.
<TAB>
Study population:
- We intend to study 13 healthy volunteers and 13 patients with a diagnosis of focal hand dystonia. Thirteen subjects for each group are needed based on the power analysis, with an additional three added to the requested accrual to account for drop-outs, yielding a maximum of 16 subjects per group. Up to 15 focal hand dystonia patients and 15 healthy volunteers may be involved in the pilot experiment. The pilot study will be stopped when a trend in the data emerges, so the total number of subjects who participate in the pilot study may end up being less than the maximum requested accrual of 15. Subjects in the pilot experiment are eligible to later participate in the main experiment.
Design:
The subject will be seated with EMG surface electrodes over the First Dorsal Interosseous (FDI) muscle of each hand monitoring muscle activity. The TMS coil will be placed on the surface of the head and the region of motor cortex corresponding to the respective hand muscle control. The baseline motor evoked potential (MEP) for the FDI muscle will be determined by TMS stimulation and EMG monitoring. A pilot experiment will be performed first. Conditioning stimuli, consisting of repetitive subthreshold TMS stimulation with three pulses at one of eight frequencies, will be delivered. A test stimulus, consisting of a single TMS pulse, will follow the conditioning stimuli at the same interval as the conditioning train, but at a suprathreshold intensity in order to determine the MEP amplitude. After every 5 subjects the pilot data will be analyzed to check for a trend in the frequencies that lead to facilitation. Once a trend emerges, the pilot study will be stopped. The four frequencies with the greatest trend toward facilitation will then be selected and used in the main experiment. The main experiment will be performed the same way as the pilot experiment, but will use only the four frequencies found in the pilot experiment. Conditioning stimuli, consisting of repetitive subthreshold TMS stimulation with three pulses at one of the selected four frequencies, will be delivered. A test stimulus, consisting of a single TMS pulse, will follow the conditioning stimuli at the same interval as the conditioning train, but at a suprathreshold intensity in order to determine the MEP amplitude.
Outcome measures:
We will compare the MEP amplitude following TMS conditioning with the baseline MEP amplitude prior to conditioning. The effect on MEP will then be compared between healthy volunteers and dystonia patients.
- Conditions
- Dystonia
- Keywords
- Repetitive TMS (rTMS), Transcranial Magnetic Stimulation (TMS), Motor Cortex, Focal Hand Dystonia, Facilitation
- Medical subject headings
- Dystonia, Dystonia, Focal, Task-Specific
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential following TMS conditioning versus the baseline MEP amplitude in dystonia patients and healthy subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start13 Feb 2013
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
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 DystoniaStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792336
- Sponsor's protocol ID
- 130076
- Other IDs
- 13-N-0076
- Status last verified
- 19 Feb 2019
- First submitted
- 13 Feb 2013
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Brown P, Farmer SF, Halliday DM, Marsden J, Rosenberg JR. Coherent cortical and muscle discharge in cortical myoclonus. Brain. 1999 Mar;122 ( Pt 3):461-72. doi: 10.1093/brain/122.3.461.
PubMed 10094255Cardin JA, Carlen M, Meletis K, Knoblich U, Zhang F, Deisseroth K, Tsai LH, Moore CI. Driving fast-spiking cells induces gamma rhythm and controls sensory responses. Nature. 2009 Jun 4;459(7247):663-7. doi: 10.1038/nature08002. Epub 2009 Apr 26.
PubMed 19396156Crowell AL, Ryapolova-Webb ES, Ostrem JL, Galifianakis NB, Shimamoto S, Lim DA, Starr PA. Oscillations in sensorimotor cortex in movement disorders: an electrocorticography study. Brain. 2012 Feb;135(Pt 2):615-30. doi: 10.1093/brain/awr332. Epub 2012 Jan 16.
PubMed 22252995
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma Frequency Transcranial Magnetic Stimulation in Dystonia
- ClinicalTrials.gov ID
- NCT01792336
- Acronym / sponsor ID
- 130076
- Conditions
- Dystonia
- Keywords
- Repetitive TMS (rTMS), Transcranial Magnetic Stimulation (TMS), Motor Cortex, Focal Hand Dystonia, Facilitation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 13 Feb 2013
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 15 Feb 2013 (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.
Background:
- The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.
- Focal hand dystonia, also known as "writer's cramp" or "musician's cramp," is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia.
Objectives:
- To better understand brain rhythms involved in focal hand dystonia.
Eligibility:
- Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.
- Healthy right-handed volunteers between 18 and 60 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.
- Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held on their scalp. A brief electrical current will pass through the coil. It creates a magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and left sides of the head. This will help find the spot that activates the finger muscles, and see how much TMS is needed.
- In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated magnetic pulses delivered in short bursts. There will be four pulses in each burst. Participants will have multiple bursts during the test. This test will look at how the muscles of the hand and fingers respond to brain stimulation.
- Treatment for focal hand dystonia will not be provided as part of this study.
Detailed description
Objectives:
The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using transcranial magnetic stimulation (TMS). The study may reveal new information about the role of gamma frequency oscillations in cortical facilitation in dystonia patients versus healthy volunteer subjects.
The findings of this study may also help to determine if abnormal gamma frequency facilitation might become a potential diagnostic tool for dystonia.
<TAB>
Study population:
- We intend to study 13 healthy volunteers and 13 patients with a diagnosis of focal hand dystonia. Thirteen subjects for each group are needed based on the power analysis, with an additional three added to the requested accrual to account for drop-outs, yielding a maximum of 16 subjects per group. Up to 15 focal hand dystonia patients and 15 healthy volunteers may be involved in the pilot experiment. The pilot study will be stopped when a trend in the data emerges, so the total number of subjects who participate in the pilot study may end up being less than the maximum requested accrual of 15. Subjects in the pilot experiment are eligible to later participate in the main experiment.
Design:
The subject will be seated with EMG surface electrodes over the First Dorsal Interosseous (FDI) muscle of each hand monitoring muscle activity. The TMS coil will be placed on the surface of the head and the region of motor cortex corresponding to the respective hand muscle control. The baseline motor evoked potential (MEP) for the FDI muscle will be determined by TMS stimulation and EMG monitoring. A pilot experiment will be performed first. Conditioning stimuli, consisting of repetitive subthreshold TMS stimulation with three pulses at one of eight frequencies, will be delivered. A test stimulus, consisting of a single TMS pulse, will follow the conditioning stimuli at the same interval as the conditioning train, but at a suprathreshold intensity in order to determine the MEP amplitude. After every 5 subjects the pilot data will be analyzed to check for a trend in the frequencies that lead to facilitation. Once a trend emerges, the pilot study will be stopped. The four frequencies with the greatest trend toward facilitation will then be selected and used in the main experiment. The main experiment will be performed the same way as the pilot experiment, but will use only the four frequencies found in the pilot experiment. Conditioning stimuli, consisting of repetitive subthreshold TMS stimulation with three pulses at one of the selected four frequencies, will be delivered. A test stimulus, consisting of a single TMS pulse, will follow the conditioning stimuli at the same interval as the conditioning train, but at a suprathreshold intensity in order to determine the MEP amplitude.
Outcome measures:
We will compare the MEP amplitude following TMS conditioning with the baseline MEP amplitude prior to conditioning. The effect on MEP will then be compared between healthy volunteers and dystonia patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of focal hand dystonia (patients only).
- Between age 18 and 70 years.
- Able to give informed consent
- Right handed
- Agrees to not drink caffeine or alcohol for 48 hours before study session.
Key exclusion criteria (12 listed)
- Has used illegal drugs within the past 6 months based on history, including but not limited to marijuana, cocaine, methamphetamine, etc. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam (other than dystonia in patient group)
- Has had a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.
- Has major depression or any major mental disorders (axis I disorders)
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
Motor evoked potential following TMS conditioning versus the baseline MEP amplitude in dystonia patients and healthy subjects.
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 10094255Brown P, Farmer SF, Halliday DM, Marsden J, Rosenberg JR. Coherent cortical and muscle discharge in cortical myoclonus. Brain. 1999 Mar;122 ( Pt 3):461-72. doi: 10.1093/brain/122.3.461.
- Background: PubMed 19396156Cardin JA, Carlen M, Meletis K, Knoblich U, Zhang F, Deisseroth K, Tsai LH, Moore CI. Driving fast-spiking cells induces gamma rhythm and controls sensory responses. Nature. 2009 Jun 4;459(7247):663-7. doi: 10.1038/nature08002. Epub 2009 Apr 26.
- Background: PubMed 22252995Crowell AL, Ryapolova-Webb ES, Ostrem JL, Galifianakis NB, Shimamoto S, Lim DA, Starr PA. Oscillations in sensorimotor cortex in movement disorders: an electrocorticography study. Brain. 2012 Feb;135(Pt 2):615-30. doi: 10.1093/brain/awr332. Epub 2012 Jan 16.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Dystonia, 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 12 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 was stopped early. 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?
Motor evoked potential following TMS conditioning versus the baseline MEP amplitude in dystonia patients and healthy subjects. (time frame: 6 months). 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 NCT01792336, 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 17 Dec 2019.