Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Assessing Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03587350
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

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

Condition or disease Intervention/treatment Phase
Dystonia Device: Shimmer monitoring Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018


Arm Intervention/treatment
Active Comparator: Interventional Treatment Device: Shimmer monitoring
The shimmer monitor, monitors movement and the range of movement.

No Intervention: Usual care



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587350


Locations
Layout table for location information
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Layout table for additonal information
Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03587350     History of Changes
Other Study ID Numbers: NE16/88973
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases