Assessing Cervical Dystonia

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

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2018-01-31

Brief Summary

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The study involves the use of a novel, non-invasive, monitoring device to measure the response to treatment with botulinum toxin injections in 24 (16 Intervention and 8 control) patients with cervical dystonia. A baseline assessment, prior to botulinum treatment,will be structured around validated clinical rating scales for cervical dystonia and questionnaires and the performance of simple neck movements, and will be undertaken while the patient wears a movement sensor attached to the head with an elastic strap. The same assessments will be undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. The patients' treatment will not be affected by their participation in the research. The device readings will then be compared with the clinical ratings to establish whether it might be used as a more sensitive measure of treatment response than clinical assessment alone. This will help clinicians to plan and execute botulinum injections more effectively in future

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Detailed Description

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Conditions

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Dystonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Interventional Treatment

Group Type ACTIVE_COMPARATOR

Shimmer monitoring

Intervention Type DEVICE

The shimmer monitor, monitors movement and the range of movement.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shimmer monitoring

The shimmer monitor, monitors movement and the range of movement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female participants aged 18 years or older (no upper age limit) and willing and able to provide informed consent.
* Participant is able and willing to comply with the follow-up schedule and protocol.
* Participants diagnosed with cervical dystonia.
* Participant has previously received botulinum toxin therapy for cervical dystonia without adverse side effects OR is naïve to botulinum toxin therapy but is suitable to participate in the investigator's opinion

Exclusion Criteria

* -Participated in another clinical investigation within 30 days.
* Allergy to device components or botulinum toxin.
* Medical co-morbidities that preclude botulinum toxin therapy.
* Patient is incapable of understanding or responding to the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No