Focal DystoniaNCT00306865
Brain Changes in Patients With Focal Hand Dystonia
An observational study of Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how chemical changes in the brain produce symptoms of hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Dystonia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2006to 14 Oct 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will have clinically documented focal hand dystonia. This criterion will be established by the preliminary screening in the NINDS Human Motor Control Section Outpatient Clinic.
- Patients (male or female) will range in age from 18 through 65 years of age. Female patients of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant patients do not participate in the study. Subjects will be asked to abstain from alcohol for one week prior to the study.
- Twenty healthy volunteers will be included; volunteers will be screened in the NINDS Human Motor Control Section Outpatient Clinic, and will have neurological and physical examinations. Healthy volunteers with chronic illnesses, taking any medication that affects the CNS will be excluded. Subjects will be asked to abstain from alcohol for one week prior to the study. Female volunteers of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant subjects do not participate in the study.
Who cannot join
- The following subjects will be excluded:
- Subjects younger than 18 and older than 65 years old.
- Subjects with MRI findings consistent with brain tumors, strokes, trauma or AVMs.
- Patients with progressive neurological disorders other than dystonia.
- Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
- Subjects with cancer, except for skin cancer.
Show all 13Show fewer
- Subjects incapable of giving an informed consent
- Subjects who are pregnant or breastfeeding
- Patients who are currently on benzodiazepines, which binds GABA-A receptors and will compete directly with flumazenil for binding; baclofen which binds GABA-B receptors; flunitrazepam, a benzodiazepine receptor agonist; or triazolam, a partial allosteric modulator of GABA A receptors. Patients need to be off of these medications for four weeks prior to entering the study.
- Patients who have had recent (within 3 months) BoTox injections. Botulinum Toxin A (BoTox) injections are commonly used to relieve pain and muscle spasms of dystonic patients.
- Participation of Children
- Patients or healthy subjects younger than 18 years of age will be excluded from the study due to the following reasons:
- Absorbed radiation dose per mCi is relatively higher, and pharmacodynamic effects are greater in children compared to adults. (ii) No direct benefit for individual patients is anticipated from this study. The study is of "greater than minimal risk", and thus does not meet the criterion of 45 CFR 46 Subpart D (the "prospect of direct benefit") governing participation of children in research.
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: Evaluation of Density and Pattern of Distribution of GABA A Receptors in the Brain of Patients With Focal Hand Dystonia Studied With PET Using [11C] Flumazenil
This study will examine how chemical changes in the brain produce symptoms of hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. The study will use positron emission tomography (PET) to find our which areas of the brain in patients with focal hand dystonia differ from healthy volunteers without focal hand dystonia.
Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations.
Read more
Participants undergo the following procedures:
- PET scanning: The PET scanner is shaped like a doughnut. The subject lies on a bed that can slide in and out of the scanner. A custom-molded plastic mask is placed on the face and head to support the head and prevent it from moving during scanning. Two radioactive substances - five doses (one per scan) of [15 O] water and one dose of [11C] flumazil are injected into the body through a vein. The dose of injected radioactive substance is very small, and they are not harmful to the body. The [15 O] water doses are injected during the first hour and scans are taken every 10 minutes. The [11C] flumazil is injected during the second hour. The radioactive substances are detected by the PET scanner and provide information on the functioning of the brain chemistry.
- MRI scanning: MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time for this study will be less than one hour. Subjects may be asked to lie still for up to 10 minutes at a time.
Read the detailed description
Objective
The purpose of this study is to determine if in focal hand dystonia there is disinhibition involving key structures of the motor control system (basal ganglia, thalamus, cerebellum and motor cortex) caused by dysfunction of the GABA-ergic neurons. The major inhibitory neurotransmitter in the central nervous system is gamma-amino butyric acid (GABA), which acts mainly through GABA A receptors, the majority of which possess the benzodiazepine binding site. Pathological processes involving GABA-ergic neurons will cause alterations in the density of GABA receptors, which can be visualized and measured with positron emission tomography (PET) using as a radioactive ligand [(11)C] Flumazenil.
Study Population
This research will be conducted using 20 patients with primary focal hand dystonia and 20 healthy volunteers that are matched by age and gender.
Design
By using positron emission tomography (PET) using radioactive ligand [(11)C] Flumazenil, we will detect alterations in the density of GABA receptors in patients with primary focal hand dystonia in comparison with control subjects.
Outcome Measures
We will be able to determine the density of GABA A receptors of the various Regions of Interest as measured by PET analysis among these groups of subjects. This study should provide new information concerning localization and degree of dysfunction of GABA-ergic neurons in movement related structures in dystonia, which might open new possibilities for pharmacological treatment of this disorder.
- Conditions
- Focal Dystonia
- Keywords
- Neurotransmitter, Neuroimaging, Movement Disorder, Focal Hand Dystonia, FHD, HV
- Medical subject headings
- Dystonic Disorders, Movement Disorders, Dystonia, Focal, Task-Specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study start17 Mar 2006
- Study completion14 Oct 2010
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
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306865
- Sponsor's protocol ID
- 060031
- Other IDs
- 06-N-0031
- Status last verified
- 14 Oct 2010
- First submitted
- 23 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bara-Jimenez W, Catalan MJ, Hallett M, Gerloff C. Abnormal somatosensory homunculus in dystonia of the hand. Ann Neurol. 1998 Nov;44(5):828-31. doi: 10.1002/ana.410440520.
PubMed 9818942Bennett BD, Bolam JP. Localisation of parvalbumin-immunoreactive structures in primate caudate-putamen. J Comp Neurol. 1994 Sep 15;347(3):340-56. doi: 10.1002/cne.903470303.
PubMed 7822489Bolam JP, Hanley JJ, Booth PA, Bevan MD. Synaptic organisation of the basal ganglia. J Anat. 2000 May;196 ( Pt 4)(Pt 4):527-42. doi: 10.1046/j.1469-7580.2000.19640527.x.
PubMed 10923985
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
- Evaluation of Density and Pattern of Distribution of GABA A Receptors in the Brain of Patients With Focal Hand Dystonia Studied With PET Using [11C] Flumazenil
- ClinicalTrials.gov ID
- NCT00306865
- Acronym / sponsor ID
- 060031
- Conditions
- Focal Dystonia
- Keywords
- Neurotransmitter, Neuroimaging, Movement Disorder, Focal Hand Dystonia, FHD, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Mar 2006
- Study completion
- 14 Oct 2010
- First posted
- 24 Mar 2006 (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 how chemical changes in the brain produce symptoms of hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. The study will use positron emission tomography (PET) to find our which areas of the brain in patients with focal hand dystonia differ from healthy volunteers without focal hand dystonia.
Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations.
Participants undergo the following procedures:
- PET scanning: The PET scanner is shaped like a doughnut. The subject lies on a bed that can slide in and out of the scanner. A custom-molded plastic mask is placed on the face and head to support the head and prevent it from moving during scanning. Two radioactive substances - five doses (one per scan) of [15 O] water and one dose of [11C] flumazil are injected into the body through a vein. The dose of injected radioactive substance is very small, and they are not harmful to the body. The [15 O] water doses are injected during the first hour and scans are taken every 10 minutes. The [11C] flumazil is injected during the second hour. The radioactive substances are detected by the PET scanner and provide information on the functioning of the brain chemistry.
- MRI scanning: MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time for this study will be less than one hour. Subjects may be asked to lie still for up to 10 minutes at a time.
Detailed description
Objective
The purpose of this study is to determine if in focal hand dystonia there is disinhibition involving key structures of the motor control system (basal ganglia, thalamus, cerebellum and motor cortex) caused by dysfunction of the GABA-ergic neurons. The major inhibitory neurotransmitter in the central nervous system is gamma-amino butyric acid (GABA), which acts mainly through GABA A receptors, the majority of which possess the benzodiazepine binding site. Pathological processes involving GABA-ergic neurons will cause alterations in the density of GABA receptors, which can be visualized and measured with positron emission tomography (PET) using as a radioactive ligand [(11)C] Flumazenil.
Study Population
This research will be conducted using 20 patients with primary focal hand dystonia and 20 healthy volunteers that are matched by age and gender.
Design
By using positron emission tomography (PET) using radioactive ligand [(11)C] Flumazenil, we will detect alterations in the density of GABA receptors in patients with primary focal hand dystonia in comparison with control subjects.
Outcome Measures
We will be able to determine the density of GABA A receptors of the various Regions of Interest as measured by PET analysis among these groups of subjects. This study should provide new information concerning localization and degree of dysfunction of GABA-ergic neurons in movement related structures in dystonia, which might open new possibilities for pharmacological treatment of this disorder.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will have clinically documented focal hand dystonia. This criterion will be established by the preliminary screening in the NINDS Human Motor Control Section Outpatient Clinic.
- Patients (male or female) will range in age from 18 through 65 years of age. Female patients of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant patients do not participate in the study. Subjects will be asked to abstain from alcohol for one week prior to the study.
- Twenty healthy volunteers will be included; volunteers will be screened in the NINDS Human Motor Control Section Outpatient Clinic, and will have neurological and physical examinations. Healthy volunteers with chronic illnesses, taking any medication that affects the CNS will be excluded. Subjects will be asked to abstain from alcohol for one week prior to the study. Female volunteers of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant subjects do not participate in the study.
Key exclusion criteria (13 listed)
- Subjects younger than 18 and older than 65 years old.
- Subjects with MRI findings consistent with brain tumors, strokes, trauma or AVMs.
- Patients with progressive neurological disorders other than dystonia.
- Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
- Subjects with cancer, except for skin cancer.
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 2 Jul 2017.
- Background: PubMed 9818942Bara-Jimenez W, Catalan MJ, Hallett M, Gerloff C. Abnormal somatosensory homunculus in dystonia of the hand. Ann Neurol. 1998 Nov;44(5):828-31. doi: 10.1002/ana.410440520.
- Background: PubMed 7822489Bennett BD, Bolam JP. Localisation of parvalbumin-immunoreactive structures in primate caudate-putamen. J Comp Neurol. 1994 Sep 15;347(3):340-56. doi: 10.1002/cne.903470303.
- Background: PubMed 10923985Bolam JP, Hanley JJ, Booth PA, Bevan MD. Synaptic organisation of the basal ganglia. J Anat. 2000 May;196 ( Pt 4)(Pt 4):527-42. doi: 10.1046/j.1469-7580.2000.19640527.x.
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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 Focal 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 3 inclusion and 13 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 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 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 NCT00306865, 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.