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Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections

NCT ID: NCT03969537

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-06-04

Brief Summary

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Many cervical dystonia (CD) patients are limited in their ability to travel to the clinic for follow-up in between injection visits.

A telemedicine visit at the time of peak effectiveness of neurotoxin treatment may be valuable in informing the neurologist's choice of muscle selection and/or dose for the next injection visit. The primary objective of this study is to investigate both patient and physician satisfaction with the use of our telemedicine tool for this type of follow-up. After assessment of the subject, the neurologist will decide whether or not the telemedicine visit was informative to the upcoming injection visit. Subjects will answer questions at the end of the visit regarding their satisfaction with the follow-up and overall telemedicine communication. The principle investigator will complete a similar survey with additional questions about information gathered from the visit to assess the primary objective.

A secure video communications platform will be used for the visit, which will occur 2-4 weeks after the patient's last neurotoxin injection (around the time of peak effectiveness). The investigating neurologist will remotely assess the patient and make notes for the next injection visit.

Detailed Description

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Conditions

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Cervical Dystonia Telemedicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Telemedicine

The patients selected to participate in the study are cervical dystonia (CD) patients who receive treatment at Vanderbilt University Medical Center, where the study takes place.

Telemedicine follow-up visit

Intervention Type OTHER

Study participants will experience two telemedicine (live audio/video) visits.

Interventions

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Telemedicine follow-up visit

Study participants will experience two telemedicine (live audio/video) visits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects of any race, aged 18 and above
* Diagnosed with cervical dystonia and being treated with neurotoxin injections at Vanderbilt University Medical Center
* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.
* Email and internet access
* Personal computing device with audio/video capability

Exclusion Criteria

* Subjects for whom participation in the study may cause medical harm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Allergan Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Charles

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Charles, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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190232

Identifier Type: -

Identifier Source: org_study_id