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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Treatment | Active Comparator |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shimmer monitoring | Device | The shimmer monitor, monitors movement and the range of movement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |