Trial · NCT04432285
Long-term Outcome of DBS Versus Botulinum Toxin Treatment in Cervical Dystonia
NCT04432285, Unknown, Oslo University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Outcome of DBS Versus Botulinum Toxin Treatment in Cervical Dystonia. Trials, record NCT04432285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04432285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Outcome of DBS Versus Botulinum Toxin Treatment in Cervical Dystonia
- NCT number
- NCT04432285
- Status
- Unknown
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Oslo University Hospital
- Conditions
- Cervical Dystonia
- Interventions
- DBS-device, implanted in GPi bilaterally, Botulinum toxin
- First posted
- 2020-06-16
- Last updated
- 2023-12-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total score of the Toronto Western Spasmodic Torticollis Rating Scale (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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | CDIP-58 is a patient-rated questionnaire that assesses disease-specific health-related quality of life. It includes 58 items grouped into eight dimensions. Summary scores of the eight dimensions are generated by summing items and are then transformed to a 0-100 scale. High scores indicate worse health. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04432285
GET https://conductscience.org/api/trials/v1/NCT04432285/registered