Assessing Cervical Dystonia

NCT03587350 | Completed

• 1 other identifier: NE16/88973
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Dystonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional Treatment

ACTIVE COMPARATOR

Device: Shimmer monitoring

Usual care

NO INTERVENTION

Interventions

Shimmer monitoring DEVICE

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

Interventional Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 16, 2018
• Study Start: April 7, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

GB (1)