ClinicalTrials.Veeva

Menu

Assessing Cervical Dystonia

T

The Leeds Teaching Hospitals NHS Trust

Status

Completed

Conditions

Dystonia

Treatments

Device: Shimmer monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03587350
NE16/88973

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Interventional Treatment
Active Comparator group
Treatment:
Device: Shimmer monitoring
Usual care
No Intervention group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems