HealthyNCT01373840
Role of Dopamine Receptors in Primary Focal Dystonias
An observational study of Healthy and Focal Dystonias, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Focal Dystonias
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any healthy control or patient with primary focal dystonia or arm or face.
Who may be able to join
- Age >20
- Male or Female
- Any race or ethnicity
- Primary focal dystonia (arm or cranial)
- Ability to give informed consent
Who cannot join
- Family history of dystonia
- Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding
- Exposure to radiation therapy
- Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc.
- History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase
- History of exposure to any drugs affecting dopaminergic systems within the last 6 months (e.g. dopamine receptor blocking agents, cocaine, amphetamine, tetrabenazine, reserpine, L-dopa, dopamine agonists, as they might affect the dopamine receptor binding or endogenous dopamine).
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- Active depression (Beck Depression Inventory_II >14)
- Cognitive impairment (Mini-Mental State Score <27)
- CNS active medications such as gabapentin or narcotics, muscle relaxants which might be given for pain in the 3 days prior to study
- History of stroke, seizure, cerebral palsy, generalized dystonia, parkinsonism, inability to hold head still during the scanning time.
Trial locations and contacts
1 site in 1 country.
About this study
Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.
- Conditions
- Healthy, Focal Dystonias
- Keywords
- focal, dystonia, dopamine, receptor
- Medical subject headings
- Dystonic Disorders, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Not described | |
| patients with focal dystonias | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perlmutter Joel, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373840
- Sponsor's protocol ID
- 201102481
- Status last verified
- May 2018
- First submitted
- 10 Jun 2011
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dopamine Receptors in Primary Focal Dystonias
- ClinicalTrials.gov ID
- NCT01373840
- Acronym / sponsor ID
- 201102481
- Conditions
- Healthy, Focal Dystonias
- Keywords
- focal, dystonia, dopamine, receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jun 2011 (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.
Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | – |
| patients with focal dystonias | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any healthy control or patient with primary focal dystonia or arm or face.
Key inclusion criteria (5 listed)
- Age >20
- Male or Female
- Any race or ethnicity
- Primary focal dystonia (arm or cranial)
- Ability to give informed consent
Key exclusion criteria (10 listed)
- Family history of dystonia
- Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding
- Exposure to radiation therapy
- Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc.
- History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase
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 15 May 2018.
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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.
Perlmutter Joel, MD principal investigator
Washington University School of Medicine
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 Healthy and Focal Dystonias, run by Washington University School of Medicine 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 5 inclusion and 10 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 15 May 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.
Where can I read the original study information?
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 15 May 2018.