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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03587350
Other study ID # NE16/88973
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 7, 2017
Est. completion date January 31, 2018

Study information

Verified date July 2018
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Shimmer monitoring
The shimmer monitor, monitors movement and the range of movement.

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful monitoring of movement by the shimmer monitor Accurate assessment of cervical dystonia at different time points to assess change over allocated time frame. 3, 6, 9 and 12 weeks post botulinum therapy
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