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Long-term Outcome in Cervical Dystonia Patients Treated With Chronic Pallidal Deep Brain Stimulation Compared to Repeated Botulinum Toxin Injections - a Cross-sectional Observational Study
Sponsor study identifier
observational
50
1 country
1
Study Start
August 6, 2020
Actual (reported)Primary Completion
January 30, 2023
Actual (reported)Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cervical dystonia (CD) is the most common isolated dystonia in adults. Cervical dystonia symptoms can in most patients be managed well by botulinum toxin (BTX) injections, and supporting treatment measures. However, one-fifth to one-third of patients do not obtain sufficient relief from long-term BTX therapy, resulting in reduced quality of life. Deep brain stimulation (DBS) is a treatment method in which electrodes are surgically implanted permanently in the brain to modulate brain networks and function. In cervical dystonia, DBS of the postero-ventral part of the internal globus pallidus (GPi-DBS) has been established as an effective treatment for severe cases. However, the outcome of GPi-DBS in cervical dystonia has been reported mostly in some smaller series with up to 3 years follow-up. Thus, there is a lack of documentation of outcome of GPi-DBS in CD beyond 3 years of treatment and in larger patient materials. In this study the investigators will perform a long-term follow-up study of patients who were operated with a DBS-device targeting the GPi bilaterally, and who have been treated with chronic GPi-DBS for a minimum of 3 years. The investigators will measure the severity of symptom burden and quality of life with validated rating scales. The investigators will compare this DBS-treated cohort with an age- and gender matched group of CD patients who are receiving the standard treatment with botulinum neurotoxin (BoNT) injections and have been treated for at least 3 years as well. The investigators hypothesize that the DBS-treated group will have a significantly lower burden of symptoms at long-term follow-up than the BoNT treated group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 11, 2020
Actual (reported)June 16, 2020
Actual (reported)August 6, 2020
Actual (reported)January 30, 2023
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total score of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
The TWSTRS is a validated clinical scale that assesses cervical dystonia symptom severity, disability and pain (Consky et al, 1990; Consky and Lang 1994; Comella et al, 1992; Dubinsky et al, 1991). In the first part the physical signs of cervical dystonia are scored by the investigator (Severity subscale), the second part rates disability/limitation of activities (Disability subscale), and the third part rates the intensity and duration of pain related to the CD, and its impact on the patient´s ability to participate in normal activities (Pain subscale). The TWSTRS Total score is the sum of the TWSTRS Severity score (0-35), the TWSTRS Disability score (0-30) and the TWSTRS Pain score (0-20), with a maximum total score of 85. Higher scores indicate more severe symptoms/disability/pain.
In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles), and 4-6 weeks after the last injection.
Severity, Disability and Pain subscores of the TWSTRS
In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles),and 4-6 weeks after the last injection.
Total score of the Cervical Dystonia Impact Profile 58 (CDIP-58)
In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles), and 4-6 weeks after the last injection.
Patients with cervical dystonia (CD) who were operated at Oslo University Hospital between June 2004 and December 2017 with a DBS-device targeting the GPi bilaterally, and who have been treated with chronic GPi-DBS for a minimum of 3 years.
CD patients who for a minimum of 3 years have received treatment with botulinum neurotoxin (BoNT) injections at regular intervals (minimum 12 injection cycles) and still are receiving them (Age- and gender matched to the GPi-DBS group)
Chronic/continuous bilateral GPi-DBS
Repeated intramuscular injections at regular intervals of around 3 months
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Adult patients who have cervical dystonia, focal or segmental, and who have been receiving either GPi-DBS, or Botulinum toxin injections, for a minimum of 3 years, and who still receives such treatment. All patients to be included give their written informed consent to participate.
Oslo University Hospital
Oslo, Norway
Inger Marie Skogseid, MDPhD
Oslo University Hospital
First Submitted
June 11, 2020
First Posted
June 16, 2020
Study Start
August 6, 2020
Actual (reported)Primary Completion
January 30, 2023
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 12, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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