DystoniaNCT01888926
The Effects of Repetitive Paired Associative Stimulation in 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: People with dystonia have serious muscle contractions that cause abnormal movements or postures. This significantly affects their daily lives. The common type is called organic. The other type is psychogenic. People with this type have typical symptoms plus some psychological effects. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2013to 2 Aug 2016
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the organic dystonia group: Primary focal dystonia diagnosed or confirmed by a movement disorders neurologist, confirmed at the initial visit by a study investigator.
- For the psychogenic dystonia group: Clinically established psychogenic dystonia or probable psychogenic dystonia, according to the Fahn and Williams criteria confirmed by a movement disorders neurologist.
- For the healthy volunteers group: Age-matched healthy volunteers three will be age matched to pyschogenic dystonia group, and three will be age matched to organic dystonia group.
- Adult patients (at least18 years old).
- Right handed.
- Ability to provide own consent
Who cannot join
- Dystonia affecting the right APB and/or FDI, or inability of the subject to perform full range-of-motion exercises with the right FDI and/or APB.
- Medical condition impairing the subject's ability to comply with the study protocol as judged by study investigator, such as but not limited to seizures, brain tumor, stroke, bipolar disorder, depression, hearing problem, uncontrolled systemic hypertension with values above 170/100, heart disease or lung disease, active respiratory disease needing intervention; and pain preventing lying still for up to 40 minutes.
- Current or prior use of botulinum toxin within 3 months prior to TMS intervention.
- Current or prior use of CNS drugs (including antidepressants, anxiolytics, anticonvulsants, antipsychotics, anti-parkinsonian drugs, hypnotics, stimulants, and/or antihistamines) within 1 week prior to TMS intervention.
- Active drug or alcohol intake more than 7 alcohol drinks/week for women and more than 14 alcoholic drinks/week for men.
- Current pregnancy and lactating women. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at least 24 hours prior to TMS procedures.
- Presence of implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, history of shrapnel injury or any other condition/device that may be contraindicated
- Inability or unwillingness of subject to provide written informed consent.
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: Investigating the Plastic Effects of Repetitive Paired Associative Stimulation (rPAS) in Dystonia
Background:
- People with dystonia have serious muscle contractions that cause abnormal movements or postures. This significantly affects their daily lives. The common type is called organic. The other type is psychogenic. People with this type have typical symptoms plus some psychological effects. Researchers will look at how rapid transcranial magnetic stimulation (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect sensations. They will compare the responses of people with different types of dystonia. They will also compare the responses of people with dystonia to responses of people without it. This study may help us learn more about the nature of different types of dystonia.
Read more
Objectives:
- To see whether TMS combined with nerve stimulation affects the brain differently in people with different types of dystonia and those without dystonia.
Eligibility:
- Individuals at least 18 years old, who are right-handed and have dystonia.
- Healthy volunteers at least 18 years old.
Design:
- Participants will have two clinical visits. Each visit will be a few hours long. They can be done on the same day.
- Participants will be screened with a medical history and physical exam.
- Participants will take several sensory tests. For these tests, electrodes will be placed on their skin. The participants will feel small electric shocks during some of the tests.
- Participants will undergo TMS. For 2 minutes, quick electrical currents will pass through a wire coil placed on their head. As this happens, researchers will ask the participants to move certain muscles.
Read the detailed description
Objective:
To investigate the effects of pairing brain and peripheral nerve stimulation in organic and psychogenic dystonia to see if this technique can differentiate them.
Study Population:
We intend to do an internal pilot study of 6 patients with organic dystonia, 6 patients with clinically definite psychogenic dystonia and 6 age-matched healthy volunteers. We will then perform an analysis to see how many subjects we need to prove or disprove a difference between groups.
Design:
Subjects will have a baseline screening visit, electromyography (EMG) and nerve stimulation, sensory threshold testing, and measurements of brain excitability using motor evoked potentials (MEPs) from transcranial magnetic stimulation (TMS). They will then undergo rapid TMS repetitively paired with stimulation of a nerve in the arm. Outcome variables will again be measured immediately after (T0), 30 minutes (T30) after, and 60 minutes (T60) after the end of brain stimulation.
Outcome Measures
Primary outcome variable: Change in MEP amplitudes at T30 from baseline
Secondary outcome variables:
- Input-output curve parameters (measured at baseline, T0, T30, and T60)
- Temporal discrimination threshold (TDT)
Exploratory Measures
- Short interval intracortical inhibition (SICI), a measure of inhibition in the motor cortex
- Influence of Val66Met BDNF polymorphism on the output variables
Repeated measures analyses of variance (ANOVA) will be used to investigate the following three factors on the outcome variables: time (four levels: baseline, T0, T30 and T60) and muscle (two levels: APB and FDI) as within-subject factor and group (three levels: organic dystonia, psychogenic dystonia, and healthy controls) as between-subjects factor. The model of repeated measures ANOVA will include the interactions between the three factors. If the interaction between muscle and group is significant, the interaction between time and group will be evaluated for each muscle separately. If significance is found for time and/or group, then the evaluation will be followed by Tukey Kramer multiple pair-wise comparisons.
- Conditions
- Dystonia
- Keywords
- rPAS, Dystonia
- Medical subject headings
- Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the motor evoked potential (MEP) amplitude at S50 after 30 minutes from rPAS (T30).
Measured: 30 minutes from rPAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study start18 Jun 2013
- Primary completion2 Aug 2016
- Study completion2 Aug 2016
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
- 19 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
- NCT01888926
- Sponsor's protocol ID
- 130163
- Other IDs
- 13-N-0163
- Status last verified
- 2 Aug 2016
- First submitted
- 26 Jun 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
Avanzino L, Martino D, van de Warrenburg BP, Schneider SA, Abbruzzese G, Defazio G, Schrag A, Bhatia KP, Rothwell JC. Cortical excitability is abnormal in patients with the "fixed dystonia" syndrome. Mov Disord. 2008 Apr 15;23(5):646-52. doi: 10.1002/mds.21801.
PubMed 18175341Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.
PubMed 14677378Cheeran B, Talelli P, Mori F, Koch G, Suppa A, Edwards M, Houlden H, Bhatia K, Greenwood R, Rothwell JC. A common polymorphism in the brain-derived neurotrophic factor gene (BDNF) modulates human cortical plasticity and the response to rTMS. J Physiol. 2008 Dec 1;586(23):5717-25. doi: 10.1113/jphysiol.2008.159905. Epub 2008 Oct 9.
PubMed 18845611
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Plastic Effects of Repetitive Paired Associative Stimulation (rPAS) in Dystonia
- ClinicalTrials.gov ID
- NCT01888926
- Acronym / sponsor ID
- 130163
- Conditions
- Dystonia
- Keywords
- rPAS, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 18 Jun 2013
- Primary completion
- 2 Aug 2016 (actual)
- Study completion
- 2 Aug 2016 (actual)
- First posted
- 28 Jun 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:
- People with dystonia have serious muscle contractions that cause abnormal movements or postures. This significantly affects their daily lives. The common type is called organic. The other type is psychogenic. People with this type have typical symptoms plus some psychological effects. Researchers will look at how rapid transcranial magnetic stimulation (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect sensations. They will compare the responses of people with different types of dystonia. They will also compare the responses of people with dystonia to responses of people without it. This study may help us learn more about the nature of different types of dystonia.
Objectives:
- To see whether TMS combined with nerve stimulation affects the brain differently in people with different types of dystonia and those without dystonia.
Eligibility:
- Individuals at least 18 years old, who are right-handed and have dystonia.
- Healthy volunteers at least 18 years old.
Design:
- Participants will have two clinical visits. Each visit will be a few hours long. They can be done on the same day.
- Participants will be screened with a medical history and physical exam.
- Participants will take several sensory tests. For these tests, electrodes will be placed on their skin. The participants will feel small electric shocks during some of the tests.
- Participants will undergo TMS. For 2 minutes, quick electrical currents will pass through a wire coil placed on their head. As this happens, researchers will ask the participants to move certain muscles.
Detailed description
Objective:
To investigate the effects of pairing brain and peripheral nerve stimulation in organic and psychogenic dystonia to see if this technique can differentiate them.
Study Population:
We intend to do an internal pilot study of 6 patients with organic dystonia, 6 patients with clinically definite psychogenic dystonia and 6 age-matched healthy volunteers. We will then perform an analysis to see how many subjects we need to prove or disprove a difference between groups.
Design:
Subjects will have a baseline screening visit, electromyography (EMG) and nerve stimulation, sensory threshold testing, and measurements of brain excitability using motor evoked potentials (MEPs) from transcranial magnetic stimulation (TMS). They will then undergo rapid TMS repetitively paired with stimulation of a nerve in the arm. Outcome variables will again be measured immediately after (T0), 30 minutes (T30) after, and 60 minutes (T60) after the end of brain stimulation.
Outcome Measures
Primary outcome variable: Change in MEP amplitudes at T30 from baseline
Secondary outcome variables:
- Input-output curve parameters (measured at baseline, T0, T30, and T60)
- Temporal discrimination threshold (TDT)
Exploratory Measures
- Short interval intracortical inhibition (SICI), a measure of inhibition in the motor cortex
- Influence of Val66Met BDNF polymorphism on the output variables
Repeated measures analyses of variance (ANOVA) will be used to investigate the following three factors on the outcome variables: time (four levels: baseline, T0, T30 and T60) and muscle (two levels: APB and FDI) as within-subject factor and group (three levels: organic dystonia, psychogenic dystonia, and healthy controls) as between-subjects factor. The model of repeated measures ANOVA will include the interactions between the three factors. If the interaction between muscle and group is significant, the interaction between time and group will be evaluated for each muscle separately. If significance is found for time and/or group, then the evaluation will be followed by Tukey Kramer multiple pair-wise comparisons.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For the organic dystonia group: Primary focal dystonia diagnosed or confirmed by a movement disorders neurologist, confirmed at the initial visit by a study investigator.
- For the psychogenic dystonia group: Clinically established psychogenic dystonia or probable psychogenic dystonia, according to the Fahn and Williams criteria confirmed by a movement disorders neurologist.
- For the healthy volunteers group: Age-matched healthy volunteers three will be age matched to pyschogenic dystonia group, and three will be age matched to organic dystonia group.
- Adult patients (at least18 years old).
- Right handed.
Key exclusion criteria (8 listed)
- Dystonia affecting the right APB and/or FDI, or inability of the subject to perform full range-of-motion exercises with the right FDI and/or APB.
- Medical condition impairing the subject's ability to comply with the study protocol as judged by study investigator, such as but not limited to seizures, brain tumor, stroke, bipolar disorder, depression, hearing problem, uncontrolled systemic hypertension with values above 170/100, heart disease or lung disease, active respiratory disease needing intervention; and pain preventing lying still for up to 40 minutes.
- Current or prior use of botulinum toxin within 3 months prior to TMS intervention.
- Current or prior use of CNS drugs (including antidepressants, anxiolytics, anticonvulsants, antipsychotics, anti-parkinsonian drugs, hypnotics, stimulants, and/or antihistamines) within 1 week prior to TMS intervention.
- Active drug or alcohol intake more than 7 alcohol drinks/week for women and more than 14 alcoholic drinks/week for men.
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
Change from baseline in the motor evoked potential (MEP) amplitude at S50 after 30 minutes from rPAS (T30).
Time frame: 30 minutes from rPAS
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 14 Feb 2018.
- Background: PubMed 18175341Avanzino L, Martino D, van de Warrenburg BP, Schneider SA, Abbruzzese G, Defazio G, Schrag A, Bhatia KP, Rothwell JC. Cortical excitability is abnormal in patients with the "fixed dystonia" syndrome. Mov Disord. 2008 Apr 15;23(5):646-52. doi: 10.1002/mds.21801.
- Background: PubMed 14677378Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.
- Background: PubMed 18845611Cheeran B, Talelli P, Mori F, Koch G, Suppa A, Edwards M, Houlden H, Bhatia K, Greenwood R, Rothwell JC. A common polymorphism in the brain-derived neurotrophic factor gene (BDNF) modulates human cortical plasticity and the response to rTMS. J Physiol. 2008 Dec 1;586(23):5717-25. doi: 10.1113/jphysiol.2008.159905. Epub 2008 Oct 9.
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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 8 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 14 Feb 2018. 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.
What does the primary outcome measure?
Change from baseline in the motor evoked potential (MEP) amplitude at S50 after 30 minutes from rPAS (T30). (time frame: 30 minutes from rPAS). 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 NCT01888926, 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 14 Feb 2018.