Cervical DystoniaNCT02959645
Assessment of Brain Activities in Cervical Dystonia
An observational study of Cervical Dystonia, run by University of Minnesota at 1 site in United States.
Trial summary
To address joint position sense in cervical dystonia patients and how it affects the brain activity. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 17 May 2018
- How long will I take part?
- 1 Day
- 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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cervical dystonia will be recruited from the University of Minnesota's Movement Disorders Clinic.
Who may be able to join
- patients having cervical dystonia and aged matched healthy control group
Who cannot join
- cervical dystonia patients with severe head tremor will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cortical Network Activities in Cervical Dystonia
To address joint position sense in cervical dystonia patients and how it affects the brain activity.
- Conditions
- Cervical Dystonia
- Medical subject headings
- Torticollis
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 |
|---|---|---|
| Cervical Dystonia | patients will have Cervical Dystonia | |
| Healthy control | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Joint Position Sense
Measured: 30 minutes
Secondary outcomes (1)
Brain Signals Recorded via Non-Invasive Surface Electromyography
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start1 Sep 2017
- Primary completion17 May 2018
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959645
- Sponsor's protocol ID
- 1607M91461
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2016
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Khosravani S, Buchanan J, Johnson MD, Konczak J. Effect of Neck Botulinum Neurotoxin Injection on Proprioception and Somatosensory-Motor Cortical Processing in Cervical Dystonia. Neurorehabil Neural Repair. 2020 Apr;34(4):309-320. doi: 10.1177/1545968320905799. Epub 2020 Feb 26.
PubMed 32102606
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cortical Network Activities in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT02959645
- Acronym / sponsor ID
- 1607M91461
- Conditions
- Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 9 Nov 2016 (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.
To address joint position sense in cervical dystonia patients and how it affects the brain activity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Dystonia | – | –patients will have Cervical Dystonia |
| Healthy control | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical dystonia will be recruited from the University of Minnesota's Movement Disorders Clinic.
Key inclusion criteria (1 listed)
- patients having cervical dystonia and aged matched healthy control group
Key exclusion criteria (1 listed)
- cervical dystonia patients with severe head tremor will be excluded
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
Hand Joint Position Sense
Time frame: 30 minutes
1 secondary outcome
Brain Signals Recorded via Non-Invasive Surface Electromyography
Time frame: 2 hours
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 11 Feb 2022.
- Results publication: PubMed 32102606Khosravani S, Buchanan J, Johnson MD, Konczak J. Effect of Neck Botulinum Neurotoxin Injection on Proprioception and Somatosensory-Motor Cortical Processing in Cervical Dystonia. Neurorehabil Neural Repair. 2020 Apr;34(4):309-320. doi: 10.1177/1545968320905799. Epub 2020 Feb 26.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Dystonia
Enrolling by invitationPhase 2
Accelerating TMS for Cervical Dystonia
Isolated Cervical Dystonia
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
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 Cervical Dystonia, run by University of Minnesota 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 1 inclusion and 1 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 11 Feb 2022. 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?
Hand Joint Position Sense (time frame: 30 minutes). 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 NCT02959645, which also lists 1 linked publication.
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 11 Feb 2022.