Trial · NCT07905612
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Standardized Facial Muscle Activity From Week 1 to Week 13 | Week 1 and Week 13 (end of treatment). | Change in standardized facial muscle activity from Week 1 to Week 13. Surface electromyography is recorded from the zygomaticus major, corrugator supercilii, and medial frontalis during emotional speech and song observation. Mean activity 1-4 seconds after stimulus onset is expressed as percentage change from a 2-second prestimulus baseline, then standardized within participant and muscle, then within participant across muscles. Both recordings at each visit are included. Activity is retained by muscle and stimulus emotion. Analyses assess overall responsiveness across emotional trials, excluding neutral/calm, and emotion-congruent responses: happy versus neutral/calm for zygomaticus; negative emotions (sad, angry, fearful, disgust) versus neutral/calm for corrugator; and surprise versus neutral/calm for frontalis. Values are unitless with no fixed limits; positive changes indicate increased activity. |
| Primary | Change in Standardized Facial Muscle Activity From Week 1 to Two Months After Treatment | Week 1 and two months after completion of the 13-week intervention. | Change in standardized facial muscle activity from Week 1 to two months after treatment completion. Surface electromyography is recorded from the zygomaticus major, corrugator supercilii, and medial frontalis during emotional speech and song observation. Mean activity 1-4 seconds after stimulus onset is expressed as percentage change from a 2-second prestimulus baseline, then standardized within participant and muscle, then within participant across muscles. Both recordings at each visit are included. Activity is retained by muscle and stimulus emotion. Analyses assess overall responsiveness across emotional trials, excluding neutral/calm, and emotion-congruent responses: happy versus neutral/calm for zygomaticus; negative emotions (sad, angry, fearful, disgust) versus neutral/calm for corrugator; and surprise versus neutral/calm for frontalis. Values are unitless with no fixed limits; positive changes indicate increased activity. |
| Primary | Change in Modified MDS-UPDRS Part III Motor Examination Total Score From Week 1 to Week 13 | Week 1 and Week 13 (end of treatment). | Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Motor impairment is assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The postural-stability item was not administered. The modified total comprises the remaining 32 ratings, each scored 0-4; eligible partially completed assessments are prorated to the 32-rating scale. Total scores range from 0 to 128, with higher scores indicating greater impairment. Change scores range from -128 to 128. Negative changes indicate reduced motor impairment. |
| Primary | Change in Modified MDS-UPDRS Part III Motor Examination Total Score From Week 1 to Two Months After Treatment | Week 1 and two months after completion of the 13-week intervention. | Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Motor impairment is assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The postural-stability item was not administered. The modified total comprises the remaining 32 ratings, each scored 0-4; eligible partially completed assessments are prorated to the 32-rating scale. Total scores range from 0 to 128, with higher scores indicating greater impairment. Change scores range from -128 to 128. Negative changes indicate reduced motor impairment. |
| Primary | Change in MDS-UPDRS Part III Facial Expression Score From Week 1 to Week 13 | Week 1 and Week 13 (end of treatment). | Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Facial expression is assessed using item 3.2 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses reduced facial expression, including blinking, spontaneous smiling, and lower-face movement. Scores range from 0 to 4, with higher scores indicating greater impairment. Change scores range from -4 to 4. Negative changes indicate reduced facial-expression impairment. |
| Primary | Change in MDS-UPDRS Part III Facial Expression Score From Week 1 to Two Months After Treatment | Week 1 and two months after completion of the 13-week intervention. | Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Facial expression is assessed using item 3.2 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses reduced facial expression, including blinking, spontaneous smiling, and lower-face movement. Scores range from 0 to 4, with higher scores indicating greater impairment. Change scores range from -4 to 4. Negative changes indicate reduced facial-expression impairment. |
| Primary | Change in MDS-UPDRS Part III Speech Score From Week 1 to Week 13 | Week 1 and Week 13 (end of treatment). | Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Speech is assessed using item 3.1 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses speech volume, modulation, and clarity. Scores range from 0 to 4, with higher scores indicating greater speech impairment. Change scores range from -4 to 4. Negative changes indicate reduced speech impairment. |
| Primary | Change in MDS-UPDRS Part III Speech Score From Week 1 to Two Months After Treatment | Week 1 and two months after completion of the 13-week intervention. | Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Speech is assessed using item 3.1 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses speech volume, modulation, and clarity. Scores range from 0 to 4, with higher scores indicating greater speech impairment. Change scores range from -4 to 4. Negative changes indicate reduced speech impairment. |
| Secondary | Emotion-Recognition Accuracy at Week 13 | Week 13 (end of treatment). | Emotion recognition is assessed during the audiovisual speech and song task. After each video, participants select the emotion portrayed. Neutral and calm are combined into a single category for both target emotions and participant responses before scoring. Each valid response is scored 1 if it matches the target category after this grouping and 0 otherwise. Accuracy is expressed as the percentage of correct responses, from 0% to 100%, with higher values indicating more accurate recognition. Responses from both recordings at the assessment visit are included. |
| Secondary | Emotion-Recognition Accuracy at Two Months After Treatment | Two months after completion of the 13-week intervention. | Emotion recognition is assessed during the audiovisual speech and song task. After each video, participants select the emotion portrayed. Neutral and calm are combined into a single category for both target emotions and participant responses before scoring. Each valid response is scored 1 if it matches the target category after this grouping and 0 otherwise. Accuracy is expressed as the percentage of correct responses, from 0% to 100%, with higher values indicating more accurate recognition. Responses from both recordings at the assessment visit are included. |
| Secondary | Emotion-Recognition Response Time at Week 13 | Week 13 (end of treatment). | Response time for selecting the emotion portrayed in the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster emotion-category responses. This measure is distinct from the response time for rating emotional intensity. |
| Secondary | Emotion-Recognition Response Time at Two Months After Treatment | Two months after completion of the 13-week intervention. | Response time for selecting the emotion portrayed in the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster emotion-category responses. This measure is distinct from the response time for rating emotional intensity. |
| Secondary | Happiness Measures Composite Score at Week 6 | Week 6 (during treatment). | Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness. |
| Secondary | Happiness Measures Composite Score at Week 13 | Week 13 (end of treatment). | Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness. |
| Secondary | Happiness Measures Composite Score at Two Months After Treatment | Two months after completion of the 13-week intervention. | Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness. |
| Secondary | PDQ-39 Summary Index at Week 6 | Week 6 (during treatment). | Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life. |
| Secondary | PDQ-39 Summary Index at Week 13 | Week 13 (end of treatment). | Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life. |
| Secondary | PDQ-39 Summary Index at Two Months After Treatment | Two months after completion of the 13-week intervention. | Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life. |
| Secondary | Emotion-Recognition Unbiased Hit Rate at Week 13 | Week 13 (end of treatment). | Emotion-recognition accuracy is adjusted for response bias using Wagner's unbiased hit rate (Hu). For each emotion, Hu is the proportion of presentations of that emotion correctly identified multiplied by the proportion of uses of that response label that are correct. Scores range from 0 to 1, with higher scores indicating better recognition after adjustment for response bias. Scores are retained by emotion. |
| Secondary | Emotion-Recognition Unbiased Hit Rate at Two Months After Treatment | Two months after completion of the 13-week intervention. | Emotion-recognition accuracy is adjusted for response bias using Wagner's unbiased hit rate (Hu). For each emotion, Hu is the proportion of presentations of that emotion correctly identified multiplied by the proportion of uses of that response label that are correct. Scores range from 0 to 1, with higher scores indicating better recognition after adjustment for response bias. Scores are retained by emotion. |
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.
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