Assessment of Brain Activities in Cervical Dystonia | NCT02959645

Studies
Assessment of Brain Activities in Cervical Dystonia

NCT02959645

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Feb 11, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Cervical Dystonia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

May 17, 2018Actual

Completion Date

May 17, 2018Actual

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2022

Last Update Posted Date

Feb 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cervical Dystonia		patients will have Cervical Dystonia
Healthy control		Healthy Volunteers

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hand Joint Position Sense		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Brain Signals Recorded via Non-Invasive Surface Electromyography		2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients having cervical dystonia and aged matched healthy control group

Exclusion Criteria:

cervical dystonia patients with severe head tremor will be excluded

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with cervical dystonia will be recruited from the University of Minnesota's Movement Disorders Clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elliott Hall-MSP Lab		Minneapolis	Minnesota	55414	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32102606	Result	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.

ID	Term
D004421	Dystonia
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms