Trial · NCT06974916
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side. | 6 Months | The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor. |
| Secondary | Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score as assessed by the blinded reviewers of the video-recordings. | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Treated Upper Limb CRST (A+B) score as assessed by the blinded reviewers of the video-recordings. Higher score means a worse tremor. |
| Secondary | Clinical Rating Scale for Tremor (CRST) part A (0-76) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in resting, postural, and action tremors of all items as measured by CRST part A. Higher score means a worse tremor. |
| Secondary | Bilateral Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-56) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Bilateral Upper Limb CRST (A+B). Higher score means a worse tremor. |
| Secondary | Total Clinical Rating Scale for Tremor (CRST) (A+B) (0-116) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Total CRST (A+B). Higher score means a worse tremor. |
| Secondary | Clinical Rating Scale for Tremor (CRST) part C (0-32) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in functional disabilities as measured by CRST part C. Higher score means a worse tremor. |
| Secondary | Axial Clinical Rating Scale for Tremor (CRST) (0-20) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Axial CRST defined as face, tongue, head tremor and voice items of CRST part A |
| Secondary | Quality of life questionnaire | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in disease specific QOL |
| Secondary | Change of tremor medication | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in tremor medication change |
| Secondary | Safety: Incidence and frequency of adverse events related to the treatment. | 6 Months, 12 Months | Incidence and frequency of adverse events related to the treatment and/or procedure. The investigator will capture any untoward events in the case report forms along with severity, duration, and resolution, and whether the event is considered serious. The severity of adverse events will be categorized according to the definition of adverse events from the International Organization for Standardization (ISO). |
| Other | Objective assessment of specific adverse events | 6 Months, 12 Months | Objective assessment of specific adverse events will be carried out for Speech, Gait and Motor Strength at baseline and 6 months and eventually at 12 months. If the adverse reported in the objective assessment is resolved at 6 months (Speech, Gait and Motor strength) it will not be carried out for the 12-month visit. |
| Other | Patient Global Impression of Change (PGIC) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Patient Global Impression of Change (PGIC). PGIC is a 7-point scale depicting a patient's rating of overall improvement. Higher score means a worse condition. |
| Other | Clinician Global Impression of Change (CGIC) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Clinician Global Impression of Change (CGIC). The CGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition. |
| Other | Caregiver Global Impression of Change (CaGIC) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Caregiver Global Impression of Change (CaGIC). The CaGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition. |
| Other | Beck Depression Inventory II | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Beck Depression Inventory II (BDI-II). The Beck Depression Inventory is a 21-question multiple-choice self-report inventory and is composed of items relating to symptoms of depression. |
| Other | Montreal Cognitive Assessment (MoCA) | 6 Months, 12 Months | Between group comparison through month 6 and within group comparison vs baseline up to month 12 in MoCA Score. The MoCA is a validated assessment that is used to detect cognitive impairment. |
| Other | Responder analysis | 6 Months | A responder analysis will be performed to compute the proportion of subjects achieving a clinically satisfactory result. The CRST will be used. The responder analysis will be based on this scoring: * Full responder: no tremor (0) or barely no tremor (1). * Partial responder: moderate tremor, \< 2cm, (2) * Insufficient responder: marked (2-4 cm, 3) or severe (\> 4 cm) |
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/NCT06974916/registered