Trial · NCT07168850
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chenge in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) | Baseline to Week 12 | The BFMDRS has a maximum score of 120 for the movement subscale and 30 for the disability subscale. Higher scores indicating more severe dystonia. |
| Secondary | Incidence of treatment-related adverse events | Baseline to Week 24 | Assessment of any treatment-related adverse events throughout the whole study period |
| Secondary | Changes in the Quick Disabilities of Arm, Shoulder & Hand (Quick-DASH) score | Baseline, Week 12 and Week 24 | The QuickDASH is a shortened, 11-item version of the DASH Outcome Measure, designed to assess physical function and symptom severity related to the arm, shoulder, and hand. Maximum score 100; the greater the score the grear the disability. |
| Secondary | Changes in the Clinical Global Impression of Change (CGIC) score | Baseline, week 12 and week 24 | The CGIC is a 7-point scale used to assess the degree of change in a patient's condition since the start of treatment or another defined baseline. Lower scores indicates improvement and higher scores indicating worsening of the patient's condition. |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline, Week 12 and week 24 | The maximum score of the PGIC is 7: the higher the score the higher the improvement reported by a patient. |
| Secondary | Change in the 36-Item Short Form Survey (SF-36) score | Baseline, week 12 and week 24 | The SF-36 questionnaire has a maximum score of 100 for each of its eight scaled scores (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). The higher the scores the more favorable is health state within that specific dimension. |
| Secondary | Changes in the Short-Interval Cortical Inhibition (SICI) | Baseline and Week 24 | This is a neurophysiological measure of inhibitory processes within the motor cortex, assessed using Transcranial Magnetic Stimulation, which is measured as the relative amplitude reduction of motor evoked potentials from the test stimulus when it is preceded by the conditioning stimulus. The greater the change in SICI, the greater the pallidotomy-induced changes in motor cortex intracortical inhibitory circuits |
| Secondary | Changes in intracortical facilitation (ICF) | Baseline and Week 24 | This is a neurophysiological measures of cortical excitability, assessed using paired-pulse Transcranial Magnetic Stimulation, which describes an increase in the magnitude of a motor evoked potential in a target muscle when a suprathreshold test pulse is preceded by a subthreshold conditioning pulse at specific interstimulus intervals. The greater the change in ICF, the greater the pallidotomy-induced changes in intracortical excitatory circuits |
| Secondary | Changes in Paired Associative Stimulation (PAS) | Baseline and week 24 | This is a neurophysiological measure of cortical plasticity assessed using transcranial magnetic stimulation. The greater the change in PAS, the greater the pallidotomy-induced changes in motor cortex synaptic plasticity |
| Secondary | Changes in brain activity (using functional connectivity) using resting-state functional magnetic resonance imaging (rs-fMRI) | Baseline and Week 24 | The investigators will conduct a region-of-interest analysis to calculate changes of fMRI functional connectivity between baseline and post-pallidotomy. |
| Secondary | Changes in pallidotomy lesion morphology via contrast MRI | 24-hour after the procedure, week 12 and week 24 | To evaluate the morphological changes of the lesion after 24 hours, 3 months and 6 months from pallidotomy using contrast-enhanced brain MRI and their relationship with clinical changes including adverse events. |
| Secondary | Changes in the Montreal Cognitive Assessment (MoCA) score | Baseline, week 12 and week 24 | Changes in the Montreal Cognitive Assessment (MoCA) score, a 30-point test of global cognitive functions. Score range: 0-30, with lower scores indicating worse cognitive function and higher scores indicating better cognitive function. |
| Secondary | Change in Digit Span test score | Baseline, week 12 and week 24] | Change in Digit Span test score, a cognitive test assessing memory functions. Score range: 0-\[insert maximum score for the test\], with lower scores indicating greater memory impairment and higher scores indicating better memory function. |
| Secondary | Change in the Stroop Test score | Baseline, week 12 and week 24 | Change in Stroop Test scores, a neuropsychological test assessing frontal-lobe executive cognitive function. Score range: \[insert minimum\]-\[insert maximum\], with higher scores or slower reaction times indicating worse executive cognitive function. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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