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Completed

NCT Number: NCT03587350

Assessing Cervical Dystonia

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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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shimmer monitoring

Device

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

Primary outcomes

  1. Successful monitoring of movement by the shimmer monitor

    Time frame: 3, 6, 9 and 12 weeks post botulinum therapy

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

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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