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Assessing Cervical Dystonia

Primary Purpose

Dystonia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Shimmer monitoring

About this trial

This is an interventional basic science trial for Dystonia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interventional Treatment

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Successful monitoring of movement by the shimmer monitor

Accurate assessment of cervical dystonia at different time points to assess change over allocated time frame.

Secondary Outcome Measures

Full Information

NCT ID

NCT03587350

First Posted

June 28, 2018

Last Updated

July 13, 2018

Sponsor

The Leeds Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT03587350

Brief Title

Assessing Cervical Dystonia

Official Title

A Single Site, Pilot Study to Assess the Efficacy of a Novel Minimally Invasive Device to Monitor Dystonic Movements in Patients With Cervical Dystonia Receiving Botulinum Toxin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 7, 2017 (Actual)

Primary Completion Date

January 31, 2018 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dystonia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional Treatment

Arm Type

Active Comparator

Arm Title

Usual care

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Shimmer monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful monitoring of movement by the shimmer monitor

Description

Accurate assessment of cervical dystonia at different time points to assess change over allocated time frame.

Time Frame

3, 6, 9 and 12 weeks post botulinum therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Leeds Teaching Hospitals NHS Trust

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

12. IPD Sharing Statement

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Assessing Cervical Dystonia

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