Focal DystoniaNCT02106936
Depotentiation in People With Focal Hand Dystonia
An observational study of Focal Dystonia and Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or postures. Musicians, writers, and athletes often get it. Researchers want to study how patients with this condition learn, a process of the brain that depends on a property called plasticity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Dystonia, Healthy Volunteers
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2014to 20 Jun 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years or older
- Must be right-handed
- FHD includes only writer s cramp
- Must be able to provide consent
- No open scalp wounds or scalp infections.
- Agrees to not drink caffeine or alcohol for 48 hours before study session.
Who cannot join
- Has used illegal drugs within the past 6 months based on history. 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, head trauma, 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 11Show fewer
- Has had a head injury where there was a loss of consciousness for more than a few seconds.
- Has metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye,
- Has known hearing loss.
- Pregnancy and lactation
- 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.
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: Depotentiation in Focal Hand Dystonia Patients
Background:
- Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or postures. Musicians, writers, and athletes often get it. Researchers want to study how patients with this condition learn, a process of the brain that depends on a property called plasticity.
Read more
Objective:
- To study brain plasticity in people with FHD.
Eligibility:
- Right-handed adults 18 years and older with FHD.
- Healthy, right-handed adult volunteers.
Design:
- Participants will be screened with medical history, physical exam, pregnancy test, and questionnaire about their right-handedness.
- Participants will have 2 study visits on 2 different days.
- Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation (TMS) pulses on the left side of the head. A brief electrical current passes through a wire coil on the scalp. They will hear a click and may feel a pulling on the skin or muscle twitches. They may have to keep their eyes open and remain alert, tense certain muscles, or perform simple finger movements.
- Forty more pulses, with 10 seconds between, will be given on the left side of the head. Some will be small, some big.
- Researchers will measure muscle response through small electrodes taped to the right hand.
- A cloth cap will be put on the participant s head. Researchers will write on tape on the cap.
- Participants will have the r-PAS. An electrical stimulator will be placed on the nerve at the right wrist. Repeated magnetic pulses will be delivered in trains or short bursts together with electrical stimulation of nerve. Participants will receive up to 840 pulses.
- Participants will be contacted after a few days for a follow-up check.
Read the detailed description
Objectives:
Primary objectives:
To explore the proper parameters creating a long-term depression (LTD)-like effect and depotentiation (DePo) by using rapid paired associative stimulation (rPAS) in focal hand dystonia (FHD) patients
Sample Size and Population:
We plan to recruit 28 healthy volunteers (HVs) and 28 FHD patients from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS.
Design:
Phase 1 deals with HVs while phase 2 deals with FHD patients. We will complete phase 1 before starting phase 2. Each phase is composed of 2 experiments. In phase 1, experiments 1 and 2 will create the LTD-like effect and DePo in HVs and in phase 2, experiments 3 and 4 will elicit the LTD-like effect and DePo in FHD patients. We will use regression analysis to show that the motor evoked potential (MEP) amplitude declines after eliciting the LTD-like effect and DePo.
Outcome measurements:
Primary outcome:
Determining the parameters for creating the LTD-like effect and DePo in HVs and FHD using rPAS
Secondary outcome:
Measuring the percent change of the MEP amplitude after applying the proper stimulus parameters causing an LTD-like effect and DePo in both HVs and FHD.
- Conditions
- Focal Dystonia, Healthy Volunteers
- Keywords
- Focal Hand Dystonia, Depotentiation, Transcranial Magnetic Stimulation (TMS), Rapid Paired Associative Stimulation, Healthy Volunteer
- Medical subject headings
- Dystonic Disorders, Dystonia, Focal, Task-Specific
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential amplitude
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start5 Mar 2014
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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 Focal 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Prachaya Srivanitchapoom, MD
- 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
- NCT02106936
- Sponsor's protocol ID
- 140070
- Other IDs
- 14-N-0070
- Status last verified
- 20 Jun 2017
- First submitted
- 3 Apr 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Centonze D, Costa C, Rossi S, Prosperetti C, Pisani A, Usiello A, Bernardi G, Mercuri NB, Calabresi P. Chronic cocaine prevents depotentiation at corticostriatal synapses. Biol Psychiatry. 2006 Sep 1;60(5):436-43. doi: 10.1016/j.biopsych.2005.11.018. Epub 2006 Feb 14.
PubMed 16476411Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.
PubMed 18566003Figiel GS, Epstein C, McDonald WM, Amazon-Leece J, Figiel L, Saldivia A, Glover S. The use of rapid-rate transcranial magnetic stimulation (rTMS) in refractory depressed patients. J Neuropsychiatry Clin Neurosci. 1998 Winter;10(1):20-5. doi: 10.1176/jnp.10.1.20.
PubMed 9547462
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depotentiation in Focal Hand Dystonia Patients
- ClinicalTrials.gov ID
- NCT02106936
- Acronym / sponsor ID
- 140070
- Conditions
- Focal Dystonia, Healthy Volunteers
- Keywords
- Focal Hand Dystonia, Depotentiation, Transcranial Magnetic Stimulation (TMS), Rapid Paired Associative Stimulation, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Prachaya Srivanitchapoom, MD
- Study start
- 5 Mar 2014
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 8 Apr 2014 (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:
- Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or postures. Musicians, writers, and athletes often get it. Researchers want to study how patients with this condition learn, a process of the brain that depends on a property called plasticity.
Objective:
- To study brain plasticity in people with FHD.
Eligibility:
- Right-handed adults 18 years and older with FHD.
- Healthy, right-handed adult volunteers.
Design:
- Participants will be screened with medical history, physical exam, pregnancy test, and questionnaire about their right-handedness.
- Participants will have 2 study visits on 2 different days.
- Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation (TMS) pulses on the left side of the head. A brief electrical current passes through a wire coil on the scalp. They will hear a click and may feel a pulling on the skin or muscle twitches. They may have to keep their eyes open and remain alert, tense certain muscles, or perform simple finger movements.
- Forty more pulses, with 10 seconds between, will be given on the left side of the head. Some will be small, some big.
- Researchers will measure muscle response through small electrodes taped to the right hand.
- A cloth cap will be put on the participant s head. Researchers will write on tape on the cap.
- Participants will have the r-PAS. An electrical stimulator will be placed on the nerve at the right wrist. Repeated magnetic pulses will be delivered in trains or short bursts together with electrical stimulation of nerve. Participants will receive up to 840 pulses.
- Participants will be contacted after a few days for a follow-up check.
Detailed description
Objectives:
Primary objectives:
To explore the proper parameters creating a long-term depression (LTD)-like effect and depotentiation (DePo) by using rapid paired associative stimulation (rPAS) in focal hand dystonia (FHD) patients
Sample Size and Population:
We plan to recruit 28 healthy volunteers (HVs) and 28 FHD patients from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS.
Design:
Phase 1 deals with HVs while phase 2 deals with FHD patients. We will complete phase 1 before starting phase 2. Each phase is composed of 2 experiments. In phase 1, experiments 1 and 2 will create the LTD-like effect and DePo in HVs and in phase 2, experiments 3 and 4 will elicit the LTD-like effect and DePo in FHD patients. We will use regression analysis to show that the motor evoked potential (MEP) amplitude declines after eliciting the LTD-like effect and DePo.
Outcome measurements:
Primary outcome:
Determining the parameters for creating the LTD-like effect and DePo in HVs and FHD using rPAS
Secondary outcome:
Measuring the percent change of the MEP amplitude after applying the proper stimulus parameters causing an LTD-like effect and DePo in both HVs and FHD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 18 years or older
- Must be right-handed
- FHD includes only writer s cramp
- Must be able to provide consent
- No open scalp wounds or scalp infections.
Key exclusion criteria (11 listed)
- Has used illegal drugs within the past 6 months based on history. 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, head trauma, 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 amplitude
Time frame: Immediate
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 2 Jul 2017.
- Background: PubMed 16476411Centonze D, Costa C, Rossi S, Prosperetti C, Pisani A, Usiello A, Bernardi G, Mercuri NB, Calabresi P. Chronic cocaine prevents depotentiation at corticostriatal synapses. Biol Psychiatry. 2006 Sep 1;60(5):436-43. doi: 10.1016/j.biopsych.2005.11.018. Epub 2006 Feb 14.
- Background: PubMed 18566003Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.
- Background: PubMed 9547462Figiel GS, Epstein C, McDonald WM, Amazon-Leece J, Figiel L, Saldivia A, Glover S. The use of rapid-rate transcranial magnetic stimulation (rTMS) in refractory depressed patients. J Neuropsychiatry Clin Neurosci. 1998 Winter;10(1):20-5. doi: 10.1176/jnp.10.1.20.
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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 Focal Dystonia and Healthy Volunteers, 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 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: stopped early, as of the sponsor's last update on 2 Jul 2017. 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 amplitude (time frame: Immediate). 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 NCT02106936, 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 2 Jul 2017.