Assessing Cervical Dystonia

Dystonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587350
• Other study ID #: NE16/88973
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Torticollis

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