DystoniaNCT00072956
The Physiology of Tricks
An observational study of Dystonia and Torticollis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the action of sensory tricks on an occurrence known as surround inhibition when there is a disorder of muscle tone affecting a single body part in isolation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dystonia, Torticollis
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2005
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nineteen patients age 18 or over with cervical dystonia with a minimal of one effective trick, 15 patients age 18 and over with cervical dystonia with no effective trick will be recruited for the study.
- For patients, the selection criteria are the presence of cervical dystonia and the minimal of one sensory trick in the patient with trick group, and no trick in the patient without trick group.
- The interview of dystonic patients will be focused on medical history, neurologic examination and effectiveness of the patient's tricks which will be accessed by measuring the degree of head rotation before and during trick application.
- The diagnosis of dystonia will rely on review of medical record, history, and clinical evaluation.
- For the patients that are receiving botulinum toxin injections, the evaluation will be done 3 months after their last injection.
- Their gender, age, or ethnic origin will not provide bias for inclusion to the study.
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- There is no evidence of higher prevalence of dystonia in any particular race, thus the races and ethnicity of the subjects recruited for this study will approximate that of the general population.
- Fifteen normal subjects age 18 and over will be recruited for the control group.
- The controls will not have dystonia or any other neurological condition.
- All subjects will sign an informed consent prior to participation in the trial, and the trial will be approved by the NINDS IRB committee.
Who cannot join
- Exclusion criteria for the trial covering both the normal control and dystonia group will include;
- Any concurrent medical or surgical condition as well as neurological or psychiatric illnesses.
- Any individual who is on medications with potential influence of the nervous system function (antidepressants, antianxiolytics, anticonvulsants, antipsychotic, antiparkinsonian, hypnotics, and stimulants).
- Patients who have received Botulinum toxin injections within 3 months of starting the protocol.
- Individual who has a pacemaker, an implanted medical pump, a metal plate or medical object in the skull or eye (for example, after brain surgery)
- Individual with a history of seizures.
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
This study will examine the action of sensory tricks on an occurrence known as surround inhibition when there is a disorder of muscle tone affecting a single body part in isolation. Surround inhibition refers to a situation that suppresses unwanted movements, known as dystonia, in surrounding muscles during voluntary actions. There are tricks-various actions-that people use to temporarily stop those unwanted movements. Such tricks can include touching the affected body part, placing an object in the mouth, pulling the hair, and others. Often these tricks are beneficial early in the illness but become less effective as it progresses. This study is guided by a hypothesis that sensory tricks will restore surround inhibition and by another hypothesis that it is the application of the tricks, not simply sensory input, that is effective in doing that restoring. Emphasis is on cervical dystonia, involuntary actions affecting the neck, in which the tricks commonly involve the cheeks and chin. The technique used in the study is transcranial magnetic stimulation (TMS).
Patients ages 18 and older who have cervical dystonia with at least one effective trick and patients with no effective trick may be eligible for this study. There will also be a control group of healthy participants.
Participants will be asked to show the sensory trick and may be asked to be videotaped. During the TMS procedure, they will be seated in a comfortable chair, with hands placed on a pillow on the lap. Small electrodes-soft strips that stick to the skin-will be placed on the skin to record the electrical activity of some muscles in the neck that are activated by the stimulation from TMS. In TMS, there will be a wire coil held over the scalp. A brief electrical current will be passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg. In addition, patients may be asked to tense certain muscles slightly or perform other simple actions so that the coil can be positioned appropriately. Patients will sometimes be asked to bite down and tap their teeth slightly for about 1-1/2 minutes at a time. They will be asked to show the sensory trick. The stimulation is usually not painful, although sometimes strong contractions of the scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure discontinued at any time. The testing session takes about 2 hours, done on an outpatient basis.
Read the detailed description
The purpose of this study is to investigate the mechanism of sensory tricks on surround inhibition in the motor cortex in focal dystonia. Sensory tricks or Geste antagoniste, are various manoeuvres used by dystonic patients to transiently diminish their spasms. Many of these manoeuvres involve motor as well as sensory input and here we use the term 'tricks' to refer to both phenomena. Little is known of this unique feature that is an evidence for the abnormality of sensorimotor integration in focal dystonia. The relief of dystonic symptoms by the application of tricks suggests its potential as a clue to the understanding of the yet unclear mechanism of dystonia. There is evidence that surround inhibition, a cortical phenomenon that functions to suppress unwanted movements in surrounding muscles during voluntary actions, is impaired in dystonia. Since tricks transiently relieve the dystonic symptoms, we hypothesize that the mechanism of tricks is the normalization of surround inhibition which is defective in dystonia.
- Conditions
- Dystonia, Torticollis
- Keywords
- Transcranial Magnetic Stimulation, Torticollis, Cervical Dystonia, Surround Inhibition, Sensory Tricks
- Medical subject headings
- Dystonia, Torticollis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2003 (estimated)
- Study startNov 2003
- Study completionOct 2005
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.
- 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
- 49 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072956
- Sponsor's protocol ID
- 040041
- Other IDs
- 04-N-0041
- Status last verified
- Oct 2005
- First submitted
- 12 Nov 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
PubMed 11222454Bara-Jimenez W, Shelton P, Sanger TD, Hallett M. Sensory discrimination capabilities in patients with focal hand dystonia. Ann Neurol. 2000 Mar;47(3):377-80.
PubMed 10716260Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
PubMed 9679773
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
- The Physiology of Tricks
- ClinicalTrials.gov ID
- NCT00072956
- Acronym / sponsor ID
- 040041
- Conditions
- Dystonia, Torticollis
- Keywords
- Transcranial Magnetic Stimulation, Torticollis, Cervical Dystonia, Surround Inhibition, Sensory Tricks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Nov 2003
- Study completion
- Oct 2005
- First posted
- 13 Nov 2003 (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 examine the action of sensory tricks on an occurrence known as surround inhibition when there is a disorder of muscle tone affecting a single body part in isolation. Surround inhibition refers to a situation that suppresses unwanted movements, known as dystonia, in surrounding muscles during voluntary actions. There are tricks-various actions-that people use to temporarily stop those unwanted movements. Such tricks can include touching the affected body part, placing an object in the mouth, pulling the hair, and others. Often these tricks are beneficial early in the illness but become less effective as it progresses. This study is guided by a hypothesis that sensory tricks will restore surround inhibition and by another hypothesis that it is the application of the tricks, not simply sensory input, that is effective in doing that restoring. Emphasis is on cervical dystonia, involuntary actions affecting the neck, in which the tricks commonly involve the cheeks and chin. The technique used in the study is transcranial magnetic stimulation (TMS).
Patients ages 18 and older who have cervical dystonia with at least one effective trick and patients with no effective trick may be eligible for this study. There will also be a control group of healthy participants.
Participants will be asked to show the sensory trick and may be asked to be videotaped. During the TMS procedure, they will be seated in a comfortable chair, with hands placed on a pillow on the lap. Small electrodes-soft strips that stick to the skin-will be placed on the skin to record the electrical activity of some muscles in the neck that are activated by the stimulation from TMS. In TMS, there will be a wire coil held over the scalp. A brief electrical current will be passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg. In addition, patients may be asked to tense certain muscles slightly or perform other simple actions so that the coil can be positioned appropriately. Patients will sometimes be asked to bite down and tap their teeth slightly for about 1-1/2 minutes at a time. They will be asked to show the sensory trick. The stimulation is usually not painful, although sometimes strong contractions of the scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure discontinued at any time. The testing session takes about 2 hours, done on an outpatient basis.
Detailed description
The purpose of this study is to investigate the mechanism of sensory tricks on surround inhibition in the motor cortex in focal dystonia. Sensory tricks or Geste antagoniste, are various manoeuvres used by dystonic patients to transiently diminish their spasms. Many of these manoeuvres involve motor as well as sensory input and here we use the term 'tricks' to refer to both phenomena. Little is known of this unique feature that is an evidence for the abnormality of sensorimotor integration in focal dystonia. The relief of dystonic symptoms by the application of tricks suggests its potential as a clue to the understanding of the yet unclear mechanism of dystonia. There is evidence that surround inhibition, a cortical phenomenon that functions to suppress unwanted movements in surrounding muscles during voluntary actions, is impaired in dystonia. Since tricks transiently relieve the dystonic symptoms, we hypothesize that the mechanism of tricks is the normalization of surround inhibition which is defective in dystonia.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Nineteen patients age 18 or over with cervical dystonia with a minimal of one effective trick, 15 patients age 18 and over with cervical dystonia with no effective trick will be recruited for the study.
- For patients, the selection criteria are the presence of cervical dystonia and the minimal of one sensory trick in the patient with trick group, and no trick in the patient without trick group.
- The interview of dystonic patients will be focused on medical history, neurologic examination and effectiveness of the patient's tricks which will be accessed by measuring the degree of head rotation before and during trick application.
- The diagnosis of dystonia will rely on review of medical record, history, and clinical evaluation.
- For the patients that are receiving botulinum toxin injections, the evaluation will be done 3 months after their last injection.
Key exclusion criteria (6 listed)
- Exclusion criteria for the trial covering both the normal control and dystonia group will include;
- Any concurrent medical or surgical condition as well as neurological or psychiatric illnesses.
- Any individual who is on medications with potential influence of the nervous system function (antidepressants, antianxiolytics, anticonvulsants, antipsychotic, antiparkinsonian, hypnotics, and stimulants).
- Patients who have received Botulinum toxin injections within 3 months of starting the protocol.
- Individual who has a pacemaker, an implanted medical pump, a metal plate or medical object in the skull or eye (for example, after brain surgery)
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 11222454Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
- Background: PubMed 10716260Bara-Jimenez W, Shelton P, Sanger TD, Hallett M. Sensory discrimination capabilities in patients with focal hand dystonia. Ann Neurol. 2000 Mar;47(3):377-80.
- Background: PubMed 9679773Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
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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 Dystonia and Torticollis, 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 10 inclusion and 6 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 NCT00072956, 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; AzTrials last refreshed its copy on 31 Oct 2026.