Trial · NCT01921270
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Baseline, Week 6, Week 12 | This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia |
| Secondary | Change in Analogue Pain Scale Score | Baseline, Week 12 | Measure of jaw pain by visual analogue scale (0-100) where 0 represents "no pain" and 100 represents the "most severe pain". |
| Secondary | Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Baseline, Week 6, Week 12 | The SCS-PD measures drooling. Individual items are scored on a scale from 0-3 where 0 represents "never" and 3 represents "always". The overall maximum score is 21. A higher score indicates greater drooling severity. A lower score indicates lesser severity. |
| Secondary | Change in Number of Tongue Bites Per Day | Baseline, Week 12 | The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day. |
| Secondary | Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Baseline, Week 6, Week 12 | Ease of chewing and swallowing will be assessed by the SDQ-20 (modified to exclude question 5 due to redundancy as it relates to drooling and question 15 which is not relevant to the study as it involves prior aspiration pneumonias). Individual items are scored from 0 (never) to 3 (very frequently). The overall score is the total for all items; a higher score indicating more frequent swallowing disturbance; a lower score indicating no or less frequent disturbance, with a possible maximum score of 39. |
| Secondary | Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating | Baseline, Week 6, Week 12 | The Fahn-Marsden Part B "Speech" Question assesses the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding. |
| Secondary | Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score | Baseline, Week 6, Week 12 | The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life. |
| Secondary | Mean Global Clinical Impression - Improvement Scale (CGI) Index Score | Week 6, Week 12 | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Responses are scored on a scale from 1 to 7; 1 represents "very much improved" and 7 represents "very much worse". |
| Secondary | Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score | Baseline, Week 6, Week 12 | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Responses are scored on a scale from 1 to 7; 1 represents "normal, not at all ill" and 7 represents "among the most extremely ill patients". |
| Secondary | Mean Global Clinical Impression- Efficacy Index Score | Week 6, Week 12 | The Clinical Global Impression - Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment. Responses range on a scale from 0 to 4 with 4 being the best response. |
| Secondary | Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater | Baseline, Week 6, Week 12 | The UDRS measures dystonia severity. The UDRS is being rated by un-blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia. |
| Secondary | Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater | Baseline, Week 6, Week 12 | This scale measures the severity of dystonia for the jaw and tongue by an un-blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia |
| Secondary | Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater | Baseline, Week 6, Week 12 | The UDRS measures dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01921270/registered